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Feasibility and effects of remotely supervised aerobic training and resistance training in older adults with mild cognitive impairment:a pilot three-arm randomised controlled trial
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作者 Xiuxiu Huang Shifang Zhang +9 位作者 Xiaoyan Zhao Xinrui Li Fulian Bao Yue Lan Yuyao Zhang Ran An Bei Li Fang Yu Yongan Sun Qiaoqin Wan 《General Psychiatry》 2025年第2期123-133,共11页
Background Evidence on the effects of different exercise interventions on cognitive function is insufficient.Aims To evaluate the feasibility and effects of remotely supervised aerobic exercise(AE)and resistance exerc... Background Evidence on the effects of different exercise interventions on cognitive function is insufficient.Aims To evaluate the feasibility and effects of remotely supervised aerobic exercise(AE)and resistance exercise(RE)interventions in older adults with mild cognitive impairment(MCI).Methods This study is a 6-month pilot three-arm randomised controlled trial.Eligible participants(n=108)were recruited and randomised to the AE group,RE group or control(CON)group with a 1:1:1 ratio.Interventions were delivered at home with remote supervision.We evaluated participants’global cognition,memory,executive function,attention,physical activity levels,physical performance and muscle strength of limbs at baseline,3 months(T1)and 6 months(T2)after randomisation.A linear mixed-effects model was adopted for data analyses after controlling for covariates.Tukey’s method was used for adjusting for multiple comparisons.Sensitivity analyses were performed after excluding individuals with low compliance rates.Results 15(13.89%)participants dropped out.The median compliance rates in the AE group and RE group were 67.31%and 93.27%,respectively.After adjusting for covariates,the scores of the Alzheimer’s Disease Assessment Scale-Cognitive subscale in the AE group decreased by 2.04(95%confidence interval(CI)−3.41 to−0.67,t=−2.94,p=0.004)and 1.53(95%CI−2.88 to−0.17,t=−2.22,p=0.028)points more than those in the CON group at T1 and T2,respectively.The effects of AE were still significant at T1(estimate=−1.70,95%CI−3.20 to−0.21,t=−2.69,p=0.021),but lost statistical significance at T2 after adjusting for multiple comparisons.As for executive function,the Stroop time interference in the RE group decreased by 11.76 s(95%CI−21.62 to−1.90,t=−2.81,p=0.015)more than that in the AE group at T2 after Tukey’s adjustment.No other significant effects on cognitive functions were found.Conclusions Both remotely supervised AE and RE programmes are feasible in older adults with MCI.AE has positive effects on global cognition,and RE improves executive function. 展开更多
关键词 cognitive function resistance exercise re interventions exercise interventions remotely supervised aerobic exercise ae aerobic training remote supervision randomised controlled mild cognitive
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Systematic review of randomised controlled trials:Probiotics for functional constipation 被引量:56
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作者 Anna Chmielewska Hania Szajewska 《World Journal of Gastroenterology》 SCIE CAS CSCD 2010年第1期69-75,共7页
AIM:To systematically evaluate and update evidence on the efficacy and safety of probiotic supplementation for the treatment of constipation. METHODS:The MEDLINE,EMBASE,CINAHL,and Cochrane Library databases were searc... AIM:To systematically evaluate and update evidence on the efficacy and safety of probiotic supplementation for the treatment of constipation. METHODS:The MEDLINE,EMBASE,CINAHL,and Cochrane Library databases were searched in May 2009 for randomised controlled trials(RCTs)performed in paediatric or adult populations related to the study aim. RESULTS:We included five RCTs with a total of 377 subjects(194 in the experimental group and 183 in the control group).The participants were adults (three RCTs,n=266)and children(two RCTs,n= 111)with constipation.In adults,data suggests a favourable effect of treatment with Bifidobacterium lactis DN-173 010,Lactobacillus casei Shirota,and Escherichia coli Nissle 1917 on defecation frequency and stool consistency.In children,L.casei rhamnosusLcr35,but not L.rhamnosus GG,showed a beneficial effect. CONCLUSION:Until more data are available,we believe the use of probiotics for the treatment of constipation condition should be considered investigational. 展开更多
关键词 randomised controlled trials CONSTIPATION PROBIOTICS ADULTS CHILDREN
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A randomised controlled comparison of injection,thermal,and mechanical endoscopic methods of haemostasis on mesenteric vessels 被引量:8
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作者 C C Hepworth S S Kadirkamanathan +1 位作者 F Gong C P Swain 《World Journal of Gastroenterology》 SCIE CAS CSCD 1998年第3期71-71,共1页
Arandomisedcontroledcomparisonofinjection,thermal,andmechanicalendoscopicmethodsofhaemostasisonmesentericves... Arandomisedcontroledcomparisonofinjection,thermal,andmechanicalendoscopicmethodsofhaemostasisonmesentericvesselsCCHepworth1,S... 展开更多
关键词 MESENTERIC comparison ENDOSCOPIC HAEMOSTASIS mechanical CONTROLLED methods of randomised VESSELS
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Volar locking distal radius plates show better short-term results than other treatment options:A prospective randomised controlled trial 被引量:21
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作者 Herwig Drobetz Lidia Koval +4 位作者 Patrick Weninger Ruth Luscombe Paula Jeffries Stefan Ehrendorfer Clare Heal 《World Journal of Orthopedics》 2016年第10期687-694,共8页
AIM To compare the outcomes of displaced distal radius fractures treated with volar locking plates and with immediate postoperative mobilisation with the outcomes of these fractures treated with modalities that necess... AIM To compare the outcomes of displaced distal radius fractures treated with volar locking plates and with immediate postoperative mobilisation with the outcomes of these fractures treated with modalities that necessitate 6 wk wrist immobilisation.METHODS A prospective,randomised controlled single-centre trial was conducted with 56 patients who had a displaced radius fracture were randomised to treatment either with a volar locking plate(n=29),or another treatment modality(n=27;cast immobilisation with or without wires or external fixator).Outcomes were measured at 12 wk.Functional outcome scores measured were the Patient-Rated Wrist Evaluation(PRWE)Score;Disabilities of the Arm,Shoulder and Hand and activities of daily living(ADLs).Clinical outcomes were wrist range of motion and grip strength.Radiographic parameters were volar inclination and ulnar variance.RESULTS Patients in the volar locking plate group had significantly better PRWE scores,ADL scores,grip strength and range of extension at three months compared with the control group.All radiological parameters were significantly better in the volar locking plate group at 3 mo.CONCLUSION The present study suggests that volar locking plates produced significantly better functional and clinical outcomes at 3 mo compared with other treatment modalities.Anatomical reduction was significantly more likely to be preserved in the plating group.Level of evidence:Ⅱ. 展开更多
关键词 Volar locking distal radius plate Prospective randomised controlled Postoperative mobilisation Distal radius fracture Short-term outcome
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Multicenter randomised controlled trial comparing the high definition white light endoscopy and the bright narrow band imaging for colon polyps 被引量:2
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作者 Rajvinder Singh Kuan Loong Cheong +10 位作者 Leonardo Zorron Cheng Tao Pu Dileep Mangira Doreen Siew Ching Koay Carmen Kee Siew Chien Ng Rungsun Rerknimitr Satimai Aniwan Tiing-Leong Ang Khean-Lee Goh Shiaw Hooi Ho James Yun-Wong Lau 《World Journal of Gastrointestinal Endoscopy》 CAS 2017年第6期273-281,共9页
AIM To compare high definition white light endoscopy and bright narrow band imaging for colon polyps' detection rates. METHODS Patients were randomised to high definition white light endoscopy(HD-WLE) or the brigh... AIM To compare high definition white light endoscopy and bright narrow band imaging for colon polyps' detection rates. METHODS Patients were randomised to high definition white light endoscopy(HD-WLE) or the bright narrow band imaging(b NBI) during withdrawal of the colonoscope. Polyps identified in either mode were characterised using b NBI with dual focus(b NBI-DF) according to the Sano's classification. The primary outcome was to compare adenoma detection rates(ADRs) between the two arms. The secondary outcome was to assess the negative predictive value(NPV) in differentiating adenomas from hyperplastic polyps for diminutive rectosigmoid lesions.RESULTS A total of 1006 patients were randomised to HD-WLE(n = 511) or b NBI(n = 495). The mean of adenoma per patient was 1.62 and 1.84, respectively. The ADRs in b NBI and HD-WLE group were 37.4% and 39.3%, respectively. When adjusted for withdrawal time(OR = 1.19, 95%CI: 1.15-1.24, P < 0.001), the use of b NBI was associated with a reduced ADR(OR = 0.69, 95%CI: 0.52-0.92). Nine hundred and thirty three polyps(86%) in both arms were predicted with high confidence. The sensitivity(Sn), specificity(Sp), positive predictive value and NPV in differentiating adenomatous from non-adenomatous polyps of all sizes were 95.9%, 87.2%, 94.0% and 91.1% respectively. The NPV in differentiating an adenoma from hyperplastic polyp using b NBI-DF for diminutive rectal polyps was 91.0%.CONCLUSION ADRs did not differ between b NBI and HD-WLE, however HD-WLE had higher ADR after adjustment of withdrawal time. b NBI surpassed the PIVI threshold for diminutive polyps. 展开更多
关键词 Narrow band imaging Dual focus High definition White light endoscopy COLON POLYPS randomised controlled trial
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Adjunctive Peony-Glycyrrhiza decoction for antipsychotic-induced hyperprolactinaemia:a meta-analysis of randomised controlled trials 被引量:3
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作者 Wei Zheng Dong-Bin Cai +8 位作者 Hai-Yan Li Yu-Jie Wu Chee H Ng Gabor S Ungvari Shan-Shan Xie Zhan-Ming Shi Xiao-Min Zhu Yu-Ping Ning Yu-Tao Xiang 《General Psychiatry》 CSCD 2018年第4期3-9,共7页
Background Hyperprolactinaemia is a common adverse effect of antipsychotics (APs). The results of Peony-Glycyrrhiza decoction (PGD) as a potentially useful adjunctivetreatment for hyperprolactinaemia are inconsis... Background Hyperprolactinaemia is a common adverse effect of antipsychotics (APs). The results of Peony-Glycyrrhiza decoction (PGD) as a potentially useful adjunctivetreatment for hyperprolactinaemia are inconsistent.Aim This meta-analysis of randomised controlled trials (RCTs) examined the effcacy and safety of adjunctive PGDtherapy for AP-induced hyperprolactinaemia.Methods English (PubMed, Embase, Cochrane Library, PsycINFO) and Chinese (Chinese National Knowledge Infrastructure, Wanfang Data) databases were systematicallysearched up to 10 June 2018. The inclusion criteria were based on PICOS-Participants: adult patients with schizophrenia; Intervention: PGD plus APs; Comparison: APs plus placebo or AP monotherapy; Outcomes: effcacy and safety; Study design: RCTs. The weighted mean difference (WMD) and risk ratio (RR) along with their 95% CIs were calculated using Review Manager (RevMan) V.5.3 software.Results Five RCTs (n=450) were included and analysed. Two RCTs (n=140) were double-blind and four RCTs (n=409) reported ‘random’ assignment with specifc description. The PGD group showed a signifcantly lower serum prolactin level at endpoint than the control group (n=380, WMD: ?32.69 ng/mL (95% CI -41.66 to 23.72), p〈0.00001, I2=97%). Similarly, the superiority of PGD over the control groups was also found in the improvement of hyperprolactinaemia-related symptoms. No difference was found in the improvement of psychiatric symptoms assessed by the Positive and Negative Syndrome Scale (n=403, WMD: -0.62 (95% CI -2.38 to 1.15), p=0.49, I^2=0%). There were similar rates of all-cause discontinuation (n=330, RR 0.93 (95% CI 0.63 to 1.37), p=0.71, I^2=0%) and adverse drug reactions between the two groups. According to the Grading of Recommendations Assessment, Development and Evaluation approach, the level of evidence of primary and secondary outcomes ranged from ‘very low’ (14.3%), ‘low’ (42.8%), ‘moderate’ (14.3%), to ‘high’ (28.6%).Conclusions Current evidence supports the adjunctive use of PGD to suppress elevated prolactin and improve prolactin-induced symptoms without signifcant adverse events in adult patients with AP-induced hyperprolactinaemia. High-quality RCTs with longer duration are needed to confrm these fndings. 展开更多
关键词 Adjunctive Peony-Glycyrrhiza decoction antipsychotic-induced hyperprolactinaemia a meta-analysis of randomised controlled trials
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Biodegradable stent or balloon dilatation for benign oesophageal stricture: Pilot randomised controlled trial 被引量:1
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作者 Anjan Dhar Helen Close +6 位作者 Yirupaiahgari K Viswanath Colin J Rees Helen C Hancock A Deepak Dwarakanath Rebecca H Maier Douglas Wilson James M Mason 《World Journal of Gastroenterology》 SCIE CAS 2014年第48期18199-18206,共8页
AIM: To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures.
关键词 Benign oesophageal stricture Biodegradable stent Endoscopic balloon dilatation Pilot study randomised controlled trial DYSPHAGIA
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Difficulties in Recruitment for a Randomised Controlled Trial of Lifestyle Intervention for Type 2 Diabetes: Implications for Diabetes Management 被引量:2
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作者 George A. Jelinek Emily Hadgkiss +7 位作者 Craig Hassed Bernard Crimmins Peter Schattner Danny Liew Rick Kausman Warrick J. Inder Siegfried Gutbrod Tracey J. Weiland 《Open Journal of Endocrine and Metabolic Diseases》 2012年第4期53-57,共5页
Objective: To report our experience of attempting a randomised controlled trial of an intensive lifestyle intervention for early type 2 diabetes delivered in a residential setting. Methods: We established a trial requ... Objective: To report our experience of attempting a randomised controlled trial of an intensive lifestyle intervention for early type 2 diabetes delivered in a residential setting. Methods: We established a trial requiring 84 participants (46 standard care and 38 intervention) to detect a 1% difference in HbA1c between intervention and control groups at 12 months, allowing for attrition. Ethics approval was obtained from Monash University. Results: The study was abandoned after five months of consistent promotion due to recruitment failure (four subjects recruited). Conclusion: It appears to be difficult for patients with diabetes to commit to a live-in period of education regarding lifestyle modification as a means of treating the illness. We recommend better education of patients and their doctors about the potential health benefits of lifestyle change to manage type 2 diabetes, and further research into novel methods of delivering lifestyle advice which are both effective and sustainable. 展开更多
关键词 Type 2 Diabetes MELLITUS randomised Controlled TRIAL Management LIFESTYLE Risk Factors
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Randomised controlled trial comparing modified Sano's and narrow band imaging international colorectal endoscopic classifications for colorectal lesions 被引量:4
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作者 Leonardo Zorrón Cheng Tao Pu Kuan Loong Cheong +7 位作者 Doreen Siew Ching Koay Sze Pheh Yeap Amanda Ovenden Mahima Raju Andrew Ruszkiewicz Philip W Chiu James Y Lau Rajvinder Singh 《World Journal of Gastrointestinal Endoscopy》 2018年第9期210-218,共9页
AIM To assess the utility of modified Sano′s(MS) vs thenarrow band imaging international colorectal endoscopic(NICE) classification in differentiating colorectal polyps.METHODS Patients undergoing colonoscopy between... AIM To assess the utility of modified Sano′s(MS) vs thenarrow band imaging international colorectal endoscopic(NICE) classification in differentiating colorectal polyps.METHODS Patients undergoing colonoscopy between 2013 and 2015 were enrolled in this trial.Based on the MS or the NICE classifications,patients were randomised for real-time endoscopic diagnosis.This was followed by biopsies,endoscopic or surgical resection.The endoscopic diagnosis was then compared to the final(blinded) histopathology.The primary endpoint was the sensitivity(Sn),specificity(Sp),positive predictive value(PPV) and negative predictive value(NPV) of differentiating neoplastic and non-neoplastic polyps(MSⅡ/Ⅱo/Ⅲa/Ⅲb vs I or NICE 1 vs 2/3).The secondary endpoints were "endoscopic resectability"(MSⅡ/Ⅱo/Ⅲa vs Ⅰ/Ⅲb or NICE 2 vs 1/3),NPV for diminutive distal adenomas and prediction of post-polypectomy surveillance intervals.RESULTS A total of 348 patients were evaluated.The Sn,Sp,PPV and NPV in differentiating neoplastic polyps from non-neoplastic polyps were,98.9%,85.7%,98.2% and 90.9% for MS;and 99.1%,57.7%,95.4% and 88.2% for NICE,respectively.The area under the receiver operating characteristic curve(AUC) for MS was 0.92(95%CI:0.86-0.98);and AUC for NICE was 0.78(95%CI:0.69,0.88).The Sn,Sp,PPV and NPV in predicting "endoscopic resectability" were 98.9%,86.1%,97.8% and 92.5% for MS;and 98.6%,66.7%,94.7% and 88.9% for NICE,respectively.The AUC for MS was 0.92(95%CI:0.87-0.98);and the AUC for NICE was 0.83(95%CI:0.75-0.90).The AUC values were statistically different for both comparisons(P = 0.0165 and P = 0.0420,respectively).The accuracy for diagnosis of sessile serrated adenoma/polyp(SSA/P) with high confidence utilizing MS classification was 93.2%.The differentiation of SSA/P from other lesions achieved Sp,Sn,PPV and NPV of 87.2%,91.5%,89.6% and 98.6%,respectively.The NPV for predicting adenomas in diminutive rectosigmoid polyps(n = 150) was 96.6% and 95% with MS and NICE respectively.The calculated accuracy of post-polypectomy surveillance for MS group was 98.2%(167 out of 170) and for NICE group was 92.1%(139 out of 151).CONCLUSION The MS classification outperformed the NICE classification in differentiating neoplastic polyps and predicting endoscopic resectability.Both classifications met ASGE PIVI thresholds. 展开更多
关键词 COLORECTAL POLYPS COLORECTAL ADENOMAS COLORECTAL NEOPLASM COLORECTAL lesions randomised controlled trial COLONOSCOPY Magnifying COLONOSCOPY Endoscopic imaging
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Acupuncture of different stimulation for the treatment of neck type cervical spondylosis:a randomised controlled trial 被引量:1
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作者 Da Li Chun-Yan Chen +2 位作者 Wei Zhang Jia-Yu Huang Ren-Hong Wan 《TMR Non-Drug Therapy》 2021年第3期34-39,共6页
Objective:To observe the difference in clinical efficacy of acupuncture with strong and weak stimulation in treating neck type cervical spondylosis.Methods:64 patients with neck type cervical spondylosis were randomly... Objective:To observe the difference in clinical efficacy of acupuncture with strong and weak stimulation in treating neck type cervical spondylosis.Methods:64 patients with neck type cervical spondylosis were randomly divided into strong stimulation group and weak stimulation group,with 32 cases in each group.The acupoints selected are Jingjiaji 5-7(cervical acupoints EX-B2 C5-C7),Tianzhu(BL10)on both sides,Houxi(SI3)on both sides,Hegu(LI4)on both sides,Geshu(BL17)on both sides,and Ashi.In the strong stimulation group,deep needling with 0.25 mm×40 mm milli-needle was performed,with a mild reinforcing-reducing method.The twisting angle was 90°-180°,the frequency was 60-90 times/min,and the needles were applied for 1 min at each point.Keep the needle for 30 minutes,twisting was performed every 10 min during the retention period.Change hands once.In the weak stimulation group,shallow acupuncture with a 0.18 mm×40 mm milli-needle was performed,with a mild reinforcing-reducing method,with a twisting angle of 60°-90°,a frequency of 30-60 times/min,and acupuncture for 10 seconds at each acupoint.Keep the needle for 30 minutes,and no needle during the retention period.Patients in both groups were treated once every 1 to 2 days,3 times a week for 2 weeks,and followed up for 1 month after all treatments.The two groups of patients were compared before and after treatment and during follow-up.The McGill pain questionnaire score and the cervical spine dysfunction index score were compared to determine the clinical efficacy.Statistical analysis was performed using SPSS 22.0 statistical software.Results:1 case drop-out in the strong stimulation group and 1 case in the weak stimulation group.The total effective rate of the strong stimulation group was 90.32%,the total effective rate of the weak stimulation group was 83.87%,and the total effective rate of the strong stimulation group was higher than that of the weak stimulation group(P<0.05).The total scores of the short-form McGill pain questionnaire,the VAS score,and the cervical spine dysfunction index scores of the two groups of patients were significantly lower than those of this group before treatment,and the difference was statistically significant(P<0.05).The total scores of the short-form McGill pain questionnaire,visual analogue scale score,and cervical spine dysfunction index scores of the strong stimulation group after treatment and follow-up were significantly lower than those of the weak stimulation group(P<0.05).Conclusion:Acupuncture with strong and weak stimulation can effectively treat patients with cervical spondylosis,and deep acupuncture with filiform needles and strong stimulation have better effect. 展开更多
关键词 ACUPUNCTURE IRRITATION Neck type cervical spondylosis randomised controlled trial
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Rhythmical massage improves autonomic nervous system function:a single-blind randomised controlled trial
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作者 Georg Seifert Jenny-Lena Kanitz +3 位作者 Carolina Rihs Ingrid Krause Katharina Witt Andreas Voss 《Journal of Integrative Medicine》 CAS CSCD 2018年第3期172-177,共6页
Background: Rhythmical massage therapy(RMT) is a massage technique used in anthroposophic medicine.Objective: The authors aimed to investigate the physiological action of RMT on the cardiovascular system by analys... Background: Rhythmical massage therapy(RMT) is a massage technique used in anthroposophic medicine.Objective: The authors aimed to investigate the physiological action of RMT on the cardiovascular system by analysing heart rate variability(HRV).Design, setting, participants and intervention: This study was a randomised, controlled and single-blinded trial, involving 44 healthy women(mean age:(26.20 ± 4.71) years). The subjects were randomised to one of three arms: RMT with aromatic oil(RA), RMT without aromatic oil(RM) or standardised sham massage(SM). In the study the subjects were exposed to a standardised stress situation followed by one of the study techniques and Holter electrocardiograms(ECGs) were recorded for 24 h.Main outcome measures: HRV parameters were calculated from linear(time and frequency domain) and nonlinear dynamics(symbolic dynamics, Poincare plot analysis) of the 24-h Holter ECG records.Results: Short-and long-term effects of massage on autonomic regulation differed significantly among the three groups. Immediately after an RMT session, stimulation of HRV was found in the groups RA and RM. The use of an aromatic oil produced greater short-term measurable changes in HRV compared with rhythmic massage alone, but after 24 h the effect was no longer distinguishable from the RM group.The lowest stimulation of HRV parameters was measured in the SM group.Conclusion: RMT causes specific and marked stimulation of the autonomic nervous system. Use of a medicinal aromatic oil had only a temporary effect on HRV, indicating that the RM causes the most relevant long-term effect. The effect is relatively specific, as the physiological effects seen in the group of subjects who received only SM were considerably less pronounced. 展开更多
关键词 Sham massage WELL-BEING MOOD ALERTNESS Relaxation Stress Heart rate variability randomised controlled trial
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Effects of moderate-intensity aerobic exercise combined with acupuncture on attention function of mentally-retarded adolescents:a randomised controlled trial
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作者 LI Shuoqi GUO Rong +4 位作者 LIU Chunjing ZHAI Jiali LI Keke LI Shiming YU Wenbing 《Journal of Traditional Chinese Medicine》 SCIE CSCD 2023年第1期154-159,共6页
OBJECTIVE:To detect the impact of moderate-intensity aerobic exercise combined with acupuncture on the attention function of mentally-retarded adolescents from the three dimensions of attention concentration,attention... OBJECTIVE:To detect the impact of moderate-intensity aerobic exercise combined with acupuncture on the attention function of mentally-retarded adolescents from the three dimensions of attention concentration,attention transfer and attention span.METHODS:A total of 48 adolescents with mild to moderate mental disabilities were recruited.The participants were randomly divided into four groups:control group(C),Traditional Chinese Medicine acupuncture group(M),moderate-intensity aerobic exercise group(E)and exercise and acupuncture combined intervention group(J).Before and after the experimental intervention,the participant’s height,weight and attention ability were measured.RESULTS:The improved range of attention total duration of the J group after the intervention was significantly higher than that of the E and M groups(P<0.05),whereas that of the latter groups was significantly higher compared to that of the C group(P<0.05).The J group showed significantly higher(P<0.05)attention span values after the intervention compared to the E,M and C groups.The C group did not show a significant difference in attention transfer at 12 weeks compared to before intervention(P>0.05),whereas the E,M and J groups increased significantly(P<0.05)after intervention than the C group.CONCLUSIONS:Moderate-intensity aerobic exercise combined with acupuncture can more effectively improve the attention concentration and attention span of mentally-retarded adolescents than aerobic exercise or acupuncture alone. 展开更多
关键词 ACUPUNCTURE EXERCISE intellectual disability ADOLESCENT attention function randomised controlled trial
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CONSORT 2010 checklist of information to include when reporting a randomised trial and further explanations
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《Neural Regeneration Research》 SCIE CAS CSCD 2011年第28期2237-2240,共4页
关键词 WHEN CONSORT 2010 checklist of information to include when reporting a randomised trial and further explanations 2010
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Ginkgo biloba Extract EGb 761® Improves Central Vestibular Vertigo in Patients Undergoing Vestibular Exercises: A Randomised Placebo-Controlled Trial
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作者 Wolfgang Heide Birgit Adlung +1 位作者 Cornelia Körtke Robert Hoerr 《Neuroscience & Medicine》 CAS 2022年第3期91-102,共12页
Background: Ginkgo biloba extract EGb 761<sup>&#174;</sup> is widely used to treat various types of vertigo. Aims: An exploratory trial was conducted to evaluate the efficacy of EGb 761<sup>&... Background: Ginkgo biloba extract EGb 761<sup>&#174;</sup> is widely used to treat various types of vertigo. Aims: An exploratory trial was conducted to evaluate the efficacy of EGb 761<sup>&#174;</sup> in addition to vestibular exercises in central vestibular vertigo caused by vertebro-basilar ischaemia. Subjects and Methods: In this randomised, placebo-controlled, double-blind trial, 40 patients were enrolled in the vertigo clinic of a neurological university hospital and treated with daily doses of 240 mg EGb 761<sup>&#174;</sup> or placebo for a period of 180 days. All patients regularly performed vestibular exercises in addition. Efficacy was assessed using: a visual analogue scale for the patients to rate the overall intensity of vertigo;a numeric scale for physician-rated change;a vertigo score based on intensity, duration, and frequency of vertigo;and electronystagmography. Results: Until day 180, the mean patient-rated intensity of vertigo decreased by 46% during EGb 761<sup>&#174;</sup> treatment and by 19% with placebo (p <sup>&#174;</sup> group compared to the placebo group. Nystagmus or other eye movement disorders were present only in small subgroups of patients without sufficient statistical power to detect differences between treatment groups. Conclusions: EGb 761<sup>&#174;</sup> alleviated vertigo caused by ischaemic lesions in the brainstem or cerebellum in patients undergoing vestibular exercises. 展开更多
关键词 Ginkgo biloba Extract EGb 761® randomised Controlled Trial (RCT) VERTIGO DIZZINESS Vestibular Exercises
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An intensive and personalised care planning programme improves clinical outcomes in patients with diabetic retinopathy:a pilot randomised controlled trial
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作者 Amudha Aravindhan Eva K.Fenwick +2 位作者 Ryan Eyn Kidd Man Aw Ai Tee Ecosse L.Lamoureux 《Annals of Eye Science》 2020年第1期9-14,共6页
Background:Using a pilot randomised controlled trial(RCT),to assess the short-term effectiveness of a structured diabetic retinopathy(DR)-specific,intensive,and personalised care planning(DR-IPCP)intervention on diabe... Background:Using a pilot randomised controlled trial(RCT),to assess the short-term effectiveness of a structured diabetic retinopathy(DR)-specific,intensive,and personalised care planning(DR-IPCP)intervention on diabetes control outcomes in Singaporeans with poorly controlled type 2 diabetes.Methods:Eighteen individuals with mild-moderate DR and poor glycemic control[HbA1c≥64 mmol/mol(≥8.0%)over two consecutive 6-month readings]were randomized to DR-IPCP(n=9)or usual care(UC,n=9).The intervention included a physician consultation,an initial personalised eye consultation with a experienced diabetes nurse educator,and three behaviour change follow-up calls.HbA1c(primary outcome),lipids and blood pressure were assessed at baseline and three months post-intervention.Participant feedback regarding the DR-IPCP program was collected at three months via a semi-structured telephone interview.Results:While no significant between-group differences were observed,DR-IPCP participants experienced significant within-group reductions in HbA1c,total cholesterol,and low density lipoprotein at follow-up compared to baseline[7 mmol/mol(−0.8%),−0.64 mmol/L,and−0.66 mmol/L,respectively].No significant within-group changes in these parameters were observed in the UC group.Following the DR-IPCP intervention,participants reported a clearer understanding of the link between diabetes management;the development and progression of DR.Conclusions:DR-IPCP provides an effective short-term improvement in diabetes control parameters in DR patients with poor diabetes control.An adequately powered and longitudinal RCT is warranted to assess the clinical,patient-centred and economic potential of this programme in this population. 展开更多
关键词 Diabetic retinopathy randomised controlled trial diabetes control personalised care planning INTERVENTION BEHAVIOUR
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Educational Video Increases Maternal Self-Efficacy for Prevention of Diarrhoea in Young Children:A Randomised Clinical Trial
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作者 Emanuella Silva Joventino Adria Marcela Vieira Ferreira +4 位作者 Maria de Fátima Pereira de Sousa Jardeliny Correa da Penha Monica Oliveira Batista Oria Paulo Cesar de Almeida Lorena Barbosa Ximenes 《Health》 2014年第21期2867-2874,共8页
The aim of this study was to compare the scores of maternal self-efficacy for child diarrhoea prevention, between intervention and control groups, according to sanitary, social and demographic characteristics. A rando... The aim of this study was to compare the scores of maternal self-efficacy for child diarrhoea prevention, between intervention and control groups, according to sanitary, social and demographic characteristics. A randomised clinical trial was carried out on 163 mothers of children under 5 years old. Data collection was conducted during two months, at two different moments (M0 and M1);at the moment M0 only the intervention group watched the educational video to promote self-efficacy for child diarrhoea prevention;at M1 (two months later) the scale was applied to both groups. In the intervention group, greater mean self-efficacy scores were obtained compared with the control group. The following variables showed statistically significant associations (p < 0.05) with maternal self-efficacy: age 35 or over;high school education;working outside the home;residence with 4 to 5 people;house not of brick or mortar;public refuse collection;piped water supply;consumption of mineral water;and public sewerage network. After use of the video “Diarrhoea: you can prevent it”, the maternal self-efficacy increased, proving that this strategy is able to assist the nursing staff in educational practices. 展开更多
关键词 Health Education DIARRHOEA INFANTILE Maternal Behaviour randomised Controlled Trial
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Episiotomy restricted to foetal indications and occurrence of severe perineal tears: systematic review and meta-analysis of randomised clinical trials
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作者 Beatriz Lorenzi Daniel Bianca Baron Geronimo +1 位作者 Gustavo Yano Callado Eduardo Félix Martins Santana 《Gynecology and Obstetrics Clinical Medicine》 2025年第4期247-254,共8页
This systematic review and meta-analysis evaluated the impact of a restrictive episiotomy protocol on the incidence of severe perineal tears in first vaginal deliveries. A comprehensive search was conducted in Pub Med... This systematic review and meta-analysis evaluated the impact of a restrictive episiotomy protocol on the incidence of severe perineal tears in first vaginal deliveries. A comprehensive search was conducted in Pub Med, CENTRAL, Embase, Latin American and Caribbean Health Sciences Literature and Clinical Trials. gov until June 2024. The study followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and was registered in PROSPERO(CRD42024550295). Randomised controlled trials comparing restrictive episiotomy(for foetal indications only) with selective episiotomy in first-time vaginal deliveries were included. Two reviewers independently extracted data, assessed bias using the Cochrane Risk of Bias tool and conducted assessment according to Grading of Recommendations Assessment, Development and Evaluation(GRADE). Statistical analyses were performed using R(v.4.4.0) and Rev Man(v.8.6.1). Two trials with a total of 785 participants met the inclusion criteria. The restrictive episiotomy group showed a 51.8% reduction in severe perineal tears(risk ratio(RR)=0.50, 95% CI 0.21 to 1.21), though this result was not statistically significant. Episiotomy rates were lower in the restrictive group(RR=0.61, 95% CI 0.49 to 0.76). There were no significant differences in minor perineal tears, intact perineum rates or neonatal outcomes between the two groups. Despite the lack of statistical significance in the reduction of severe perineal tear occurrence, the findings suggest a trend towards improved perineal outcomes with restrictive episiotomy. Additionally, given the potential physical and psychological consequences of episiotomies, limiting their use to foetal indications may be beneficial. Further research is needed to confirm these findings and guide clinical practice. 展开更多
关键词 episiotomy randomised controlled trials restrictive protocol first vaginal delivery systematic review severe perineal tears restrictive episiotomy protocol
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Synchronous tele-interpersonal psychotherapy versus tele-cognitive behavioural therapy for adults:which works better?Results from a randomised clinical trial
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作者 Luiza Silveira Lucas Bruno Lo lacono Borba +9 位作者 Bruno Martini de Azevedo Alexandro Cagliari Andreia Rosane de Moura Valim Edna Linhares Garcia Silvia Virginia Coutinho Areosa Alessandra Menezes Morelle Marzie Rita Alves Damin Simone Stulp Alana Castro Panzenhagen Flávio Milman Shansis 《General Psychiatry》 2025年第5期369-378,共10页
Background Tele-cognitive behavioural therapy(t-CBT)is the most studied remote therapy,and evidence supports its efficacy in treating depression and anxiety symptoms.Aims To compare the effectiveness of tele-interpers... Background Tele-cognitive behavioural therapy(t-CBT)is the most studied remote therapy,and evidence supports its efficacy in treating depression and anxiety symptoms.Aims To compare the effectiveness of tele-interpersonal psychotherapy(t-IPT)to that of t-CBT.We hypothesise that t-IPT is as effective as t-CBT.Methods We conducted a randomised clinical trial with two parallel arms and equal randomisation.The allocation was on a 1∶1 ratio based on a computerised randomisation sequence of permuted blocks of 50.Interventions and assessments were done via a website designed specifically for the trial.Participants were community-based adults with symptoms of anxiety,depression or irritability who received four sessions of t-CBT or t-IPT.The main outcome measures were the Patient Health Questionnaire-9 for depressive symptoms,Generalised Anxiety Disorder-7 for anxiety symptoms and Affective Reactivity Index for irritability.Results 149 individuals with a mean(standard deviation)age of 32.51(10.73)years were randomised to receive t-CBT(n=73)or t-IPT(n=76).Seven participants withdrew from the interventions(t-CBT,n=4;t-IPT,n=3),and 20 participants completed the interventions but did not complete the follow-up questionnaires(t-CBT,n=9;t-IPT,n=11).Analysis was conducted by intention-to-treat.There was a significant overall reduction in symptoms of depression,anxiety and irritability(p<0.001)in both treatment arms;neither modality was superior to the other.Effectiveness analysis showed that the two interventions were equivalent.Conclusions In community adults,t-IPT is as effective as t-CBT in treating symptoms of anxiety,depression or irritability. 展开更多
关键词 Depression Anxiety computerised randomisation sequence remote therapyand Teletherapy Interpersonal Psychotherapy treating depression anxiety symptomsaims Cognitive Behavioral Therapy
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DRug-coated Balloon for Endovascular treatment of sYmptOmatic intracraNial stenotic Disease(DR.BEYOND):the protocol of a multicentre randomised trial 被引量:1
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作者 Dapeng Mo Xu Tong +4 位作者 Xiaoqing Li Chuan Qin Yuesong Pan Sheng Guan Zhongrong Miao 《Stroke & Vascular Neurology》 2025年第2期269-275,共7页
Background Although endovascular stenting is considered an effective and safe therapeutic option for symptomatic intracranial atherosclerotic disease(sICAD),an elevated rate of restenosis remains an important issue fo... Background Although endovascular stenting is considered an effective and safe therapeutic option for symptomatic intracranial atherosclerotic disease(sICAD),an elevated rate of restenosis remains an important issue for the conventional bare-metal stent(BMS).Recent evidence from observational studies suggests that applying drug-coated balloons(DCB)in sICAD may decrease restenosis occurrence.Additional large randomised studies are warranted to provide firmer evidence and to determine which patients would benefit most from DCB.Aim To design a randomised trial to examine DCB angioplasty(Taijieweiye intracranial paclitaxel-coated balloon catheter)versus BMS stenting(Wingspan intracranial stent system)in patients with sICAD.Design This is a multicentre,prospective,randomised,open-label,blinded end-point study to assess whether DCB angioplasty reduces the risk of restenosis compared with BMS stenting in sICAD patients with high-grade stenosis(≥70%-99%).Our goal is to randomly assign 198 eligible individuals at a 1:1 ratio to undergo DCB angioplasty(intervention group)or BMS stenting(control group).Outcome The primary efficacy outcome is restenosis at 6 months post treatment,that is,>50%stenosis in or within 5 mm of the treated segment and>20%absolute luminal loss.The primary safety outcome is stroke or death within 30 days post treatment.Discussion The DRug-coated Balloon for Endovascular treatment of sYmptOmatic intracraNial stenotic Disease trial aims to produce strong evidence on the efficacy and safety of DCB angioplasty as a promising therapeutic option for sICAD cases with high-grade stenosis. 展开更多
关键词 Randomized Trial large randomised studies RESTENOSIS observational studies Drug Coated Balloons Endovascular Treatment endovascular stenting intracranial atherosclerotic disease sicad
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Impact of different types of physical exercise on sleep quality in older population with insomnia:a systematic review and network meta-analysis of randomised controlled trials
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作者 Pakwan Bahalayothin Kittiphon Nagaviroj Thunyarat Anothaisintawee 《Family Medicine and Community Health》 2025年第1期33-44,共12页
Objective To measure the impact of each type of exercise on sleep quality and identify the exercise that enhances sleep quality the most.Study selection Eligible randomised controlled trials that compare physical exer... Objective To measure the impact of each type of exercise on sleep quality and identify the exercise that enhances sleep quality the most.Study selection Eligible randomised controlled trials that compare physical exercise to routine activities,usual care,non-physical activity,or health education to measure the Pittsburgh Sleep Quality Index.Data source Studies retrieved from Medline,Embase,CINAHL,Scopus,ClinicalTrial.gov and ThaiJo from the database’s inception to October 2022.Data extraction and synthesis Two reviewers independently identified studies,collected data and assessed bias.In the absence of heterogeneity,a fixed effect model was used for pairwise meta-analysis.Alternatively,a random effect model was used.A two-stage network meta-analysis used the surface under the cumulative ranking curve(SUCRA)to compare exercise efficacy.Main outcome Global Pittsburgh Sleep Quality Index(GPSQI)and subdomain score.Results This review comprised 2170 people from 25 trials.Direct meta-analysis revealed significant improvement in GPSQI with combined exercise(unstandardised mean difference(USMD)−2.35,95%CI−3.13 to-1.57,p<0.001,I^(2)=69.13%).GPSQI decreased considerably with aerobic activity(USMD−4.36,95%CI−7.86 to-0.86,p=0.01,I^(2)=97.83%).For the network meta-analysis,strengthening,aerobic and combination exercise significantly lowered GPSQI(USMD−5.75,-3.76 and−2.54,respectively).Strength training improved GPSQI scores most effectively(SUCRA 94.6%).Conclusion Exercise that strengthens muscles,rather than aerobic or combination exercises,is the most effective way to enhance sleep quality. 展开更多
关键词 Physical exercise Older population randomised controlled trials Sleep quality INSOMNIA measure impact physical exercise extraction synthesis tw
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