scholarly journals Randomised controlled trial (RCT) study design for a large-scale municipal fall prevention exercise programme in community-living older women: study protocol for the Kuopio Fall Prevention Study (KFPS)

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e028716
Author(s):  
Tommi Vilpunaho ◽  
Heikki Kröger ◽  
Risto Honkanen ◽  
Heli Koivumaa-Honkanen ◽  
Joonas Sirola ◽  
...  
Keyword(s):  
Older Women ◽  
Fall Prevention ◽  
Large Scale ◽  
Study Groups ◽  
Exercise Programme ◽  
Healthy Ageing ◽  
Community Living ◽  
Control Group ◽  
Mineral Density ◽  
Randomised Controlled

IntroductionFalls are a substantial health problem in seniors, causing fractures and being the leading cause of fatal injuries. The benefits of physical activity in fall prevention have been shown in randomised controlled trials (RCTs) in small cohorts (eg, ≤200 persons), but there is a gap between the known health effects of exercise and the large-scale implementation of effective activity in communities. Mental health and subjective well-being (SWB) should also be studied since they are strongly related to healthy ageing. Thus far, the proven efficacy of communal strategies to reduce falls and improve healthy ageing is sparse.Methods and analysisIn 2016, a 2-year RCT was launched in Kuopio, Finland to estimate the efficacy of a large, population-based, fall prevention exercise programme in community-living older women (born 1932–1945). Both the intervention and control group (n=457+457) receive health education. The intervention group is also offered free 6-month supervised training courses (weekly gym training and Taiji sessions), followed by a free 6-month unsupervised use of exercise facilities, as well as unsupervised low-cost exercise is also offered for another 12 months. During the whole 24-month follow-up, controls are free to pursue all their normal physical activities. Both study groups undergo the study measurements three times. Outcome measures include recording of falls, injuries, bone mineral density, changes in health and functional status and cognitive performance, deaths and SWB. Finally, the cost-effectiveness and cost–utility analysis will be conducted from the societal view. The main analyses comparing outcomes between study groups will be conducted using the intention to treat principle.Ethics and disseminationThe study has been reviewed and approved by the Research Ethics Committee of the Hospital District of North Savo. All regulations and measures of ethics and confidentiality are handled in accordance with the Declaration of Helsinki.Trial registration numberNCT02665169; Pre-results.

scholarly journals Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040108
Author(s):  
Rowan W Johnson ◽  
Sian A Williams ◽  
Daniel F Gucciardi ◽  
Natasha Bear ◽  
Noula Gibson
Keyword(s):  
Exercise Prescription ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Programme ◽  
Home Exercise ◽  
Control Group ◽  
Neurodevelopmental Disabilities ◽  
Home Exercise Programme ◽  
Exercise Programmes ◽  
Randomised Controlled

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.

scholarly journals Multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson’s

2019 ◽  
Vol 90 (7) ◽  
pp. 774-782 ◽  
Author(s):  
Kim Chivers Seymour ◽  
Ruth Pickering ◽  
Lynn Rochester ◽  
Helen C Roberts ◽  
Claire Ballinger ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Fall Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Prevention Programme ◽  
Control Group ◽  
Chair Stand ◽  
Subgroup Analyses ◽  
Randomised Controlled ◽  
Fall Prevention Programme

ObjectiveTo estimate the effect of a physiotherapist-delivered fall prevention programme for people with Parkinson’s (PwP).MethodsPeople at risk of falls with confirmed Parkinson’s were recruited to this multicentre, pragmatic, investigator blind, individually randomised controlled trial with prespecified subgroup analyses. 474 PwP (Hoehn and Yahr 1–4) were randomised: 238 allocated to a physiotherapy programme and 236 to control. All participants had routine care; the control group received a DVD about Parkinson’s and single advice session at trial completion. The intervention group (PDSAFE) had an individually tailored, progressive home-based fall avoidance strategy training programme with balance and strengthening exercises. The primary outcome was risk of repeat falling, collected by self-report monthly diaries, 0–6 months after randomisation. Secondary outcomes included Mini-BESTest for balance, chair stand test, falls efficacy, freezing of gait, health-related quality of life (EuroQol EQ-5D), Geriatric Depression Scale, Physical Activity Scale for the Elderly and Parkinson’s Disease Questionnaire, fractures and rate of near falling.ResultsAverage age is 72 years and 266 (56%) were men. By 6 months, 116 (55%) of the control group and 125 (61.5%) of the intervention group reported repeat falls (controlled OR 1.21, 95% CI 0.74 to 1.98, p=0.447). Secondary subgroup analyses suggested a different response to the intervention between moderate and severe disease severity groups. Balance, falls efficacy and chair stand time improved with near falls reduced in the intervention arm.ConclusionPDSAFE did not reduce falling in this pragmatic trial of PwP. Other functional tasks improved and reduced fall rates were apparent among those with moderate disease.Trial registration numberISRCTN48152791.

scholarly journals Does tension applied in kinesio taping affect pain or function in older women with knee osteoarthritis? A randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041121
Author(s):  
Yago Tavares Pinheiro ◽  
Germanna Medeiros Barbosa ◽  
Hilmaynne Renaly Fonseca Fialho ◽  
César Augusto Medeiros Silva ◽  
Jaciara de Oliveira Anunciação ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Older Women ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Group Differences ◽  
Control Group ◽  
Kinesio Taping ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo analyse the short-term effects of kinesio taping (KT) with tension (KTT) or without tension (KTNT) in older women with knee osteoarthritis (KOA), and compare them to controls who did not receive KT.DesignRandomised controlled trial.SettingUniversity physiotherapy school clinic.ParticipantsForty-five older women (fifteen participants per group) with 66.8 (±5.6) years and clinical diagnosis of KOA were assessed pre, post and 3 days after intervention.InterventionsParticipants were randomly allocated to KTT, who received two simultaneous applications of KT with tension on the knee and rectus femoris; KTNT, who received the same application as the KTT group, but without tension and a control group that attended a class on KOA.Primary and secondary outcome measuresPrimary outcome was pain intensity and secondary outcomes were knee-related health status, functional capacity, muscle strength and global rating of change.ResultsNo between-group differences were observed in pain after the first intervention (KTT vs KTNT: mean difference (MD), −1.8 points; 95% CI −4.2 to 0.5; KTT vs control: MD, −1.2 points; 95% CI −3.6 to 1.2; KTNT vs control: MD, 0.66 points; 95% CI −1.7 to 3.0) or 3 days later (KTT vs KTNT: MD, −1.3 points; 95% CI −3.7 to 1.0; KTT vs control: MD, 0.13 points; 95% CI −2.2 to 2.5; KTNT vs control: MD, 1.4 points; 95% CI −0.9 to 3.8). The lack of between-group differences was also found for secondary outcomes.ConclusionThe short-term use of KT with or without tension in older woman with KOA had no beneficial effects on pain and function. These findings call into question the clinical use of KT as a non-pharmacological therapy for this population.Trial registration numberNCT03624075.

scholarly journals 86 Developing the Adapted Lifestyle - Integrated Functional Exercise Programme in Thai Context (TLIFE) to Prevent Falls among Older Adults in Thailand: A Mixed Methods Study

2019 ◽  
Vol 48 (Supplement_4) ◽  
pp. iv18-iv27
Author(s):  
Sasiporn Ounjaichon ◽  
Chris Todd ◽  
Emma Stanmore ◽  
Elisabeth Boulton
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Retention Rate ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Programme ◽  
Community Dwelling ◽  
Control Group ◽  
Functional Exercise ◽  
Randomised Controlled

Abstract Introduction Falls are the leading cause of injuries in older Thai adults. There is a need to develop a fall prevention exercise programme to encourage participation and adherence. The adapted Lifestyle-integrated Functional Exercise (aLiFE) programme may be suitable by integrating exercise into daily routines as opposed to attending an exercise class. This study aimed to explore the acceptability and feasibility of the aLiFE programme in Thai context (TLiFE) among older Thai adults. Methods Based on the findings of a prior qualitative study, a feasibility randomised controlled trial (RCT) of TLiFE was conducted among community-dwelling older adults, comparing the TLiFE intervention group with a usual care control group. Outcome measures were analysed at baseline, 3 months, and after 6 months of the intervention. Results We recruited a total of 72 older adults into the RCT, randomised to TLiFE (n=36) and control (n=36). The retention rate at 6 months was 91.7%. Attendance in the intervention group (3 home visits and 4 follow-up calls) was 82.9%. There were no differences in fall incidence between the groups. The acceptability survey reveals TLiFE is easy to perform in daily life, safe, and useful. No adverse events were reported. Conclusion The TLiFE programme appears to be acceptable and feasible to deliver to community-dwelling older Thai adults. This feasibility study was not powered to detect a difference between groups. A further fully powered definitive randomised controlled trial of TLiFE is needed to evaluate long-term outcomes and cost-effectiveness before it is integrated within the healthcare system in Thailand.

scholarly journals Markers of cardiovascular risk are not changed by increased whole-grain intake: the WHOLEheart study, a randomised, controlled dietary intervention

2010 ◽  
Vol 104 (1) ◽  
pp. 125-134 ◽  
Author(s):  
Iain A. Brownlee ◽  
Carmel Moore ◽  
Mark Chatfield ◽  
David P. Richardson ◽  
Peter Ashby ◽  
...  
Keyword(s):  
Observational Studies ◽  
Large Scale ◽  
Dietary Intervention ◽  
Plasma Lipid ◽  
Study Groups ◽  
Risk Markers ◽  
Whole Grain ◽  
Cvd Risk ◽  
Percentage Body Fat ◽  
Randomised Controlled

Recommendations for whole-grain (WG) intake are based on observational studies showing that higher WG consumption is associated with reduced CVD risk. No large-scale, randomised, controlled dietary intervention studies have investigated the effects on CVD risk markers of substituting WG in place of refined grains in the diets of non-WG consumers. A total of 316 participants (aged 18–65 years; BMI>25 kg/m2) consuming < 30 g WG/d were randomly assigned to three groups: control (no dietary change), intervention 1 (60 g WG/d for 16 weeks) and intervention 2 (60 g WG/d for 8 weeks followed by 120 g WG/d for 8 weeks). Markers of CVD risk, measured at 0 (baseline), 8 and 16 weeks, were: BMI, percentage body fat, waist circumference; fasting plasma lipid profile, glucose and insulin; and indicators of inflammatory, coagulation, and endothelial function. Differences between study groups were compared using a random intercepts model with time and WG intake as factors. Although reported WG intake was significantly increased among intervention groups, and demonstrated good participant compliance, there were no significant differences in any markers of CVD risk between groups. A period of 4 months may be insufficient to change the lifelong disease trajectory associated with CVD. The lack of impact of increasing WG consumption on CVD risk markers implies that public health messages may need to be clarified to consider the source of WG and/or other diet and lifestyle factors linked to the benefits of whole-grain consumption seen in observational studies.

scholarly journals Efficacy of the WATERinMOTION Aquatics Exercise Programme on the Body Weight and Composition of Sedentary Older Women with Overweight/Obesity

2021 ◽  
Vol 10 (2) ◽  
pp. 19-24
Author(s):  
Mohammadreza Rezaeipour ◽  
◽  
Gennady Leonidovich Apanasenko ◽  
Zahra Raghi ◽  
◽  
...  
Keyword(s):  
Body Weight ◽  
Older Women ◽  
Fat Mass ◽  
Exercise Program ◽  
Exercise Programme ◽  
Nutritional Intervention ◽  
The Body ◽  
Control Group ◽  
Convenience Sample ◽  
Significant Difference

Some controversy remains regarding the effects of aquatic exercise on body weight and composition. The purpose of this study was to determine the short-term impacts of the WATERinMOTION aquatics exercise program on body weight and composition without nutritional intervention in sedentary older women with overweight/ obesity. The study was developed as a quasi-experimental project (pre/post-study). Forty-four inactive women were volunteers from a convenience sample with a mean age of 71.1±5.7 years (Ukraine, 2019). Participants were allocated randomly into two groups: WATERinMOTION (n=22) or a control group (n=22). Meanwhile, the WATERinMOTION group performed the WATERinMOTION exercise programme with two weekly sessions of 55 minutes each. The control subjects did not participate in any physical exercises. They were asked to perform their routine activities during the study. Both programmes lasted one month. Height, body weight, body mass index (BMI), waist circumference (WC), fat mass (FM), total body water (TBW), and free fat mass (FFM) were the anthropometric variables that were measured pre/post-study. The analysis found statistically significant differences in body weight (-0.7, P=0.004), BMI (-0.3, P=0.002), and FM (-0.6, P=0.03) between the pre and post measurements of the WATERinMOTION group. Moreover, the comparison of groups at post revealed a significant difference in body weight (P˂0.001), BMI (P˂0.001), TBW (P=0.005), FM (P˂0. 001), FFM (P=0.003), and WC (P=0.007). The WATERin- MOTION programme, which is not associated with nutritional monitoring, showed significant benefits for losing weight and the body composition of sedentary older women who are overweight and/or obese.

Effectiveness of two tobacco cessation methods among TB patients

2022 ◽  
Vol 26 (1) ◽  
pp. 12-17
Author(s):  
S. Malhotra ◽  
V. Mohanty ◽  
A. Y. Balappanavar ◽  
N. Sharma ◽  
A. Khanna ◽  
...  
Keyword(s):  
Tobacco Cessation ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Study Groups ◽  
Adverse Outcomes ◽  
Control Group ◽  
Treatment Groups ◽  
Integrated Intervention ◽  
Randomised Controlled ◽  
And Control

BACKGROUND: Tobacco and TB are the world´s two greatest public health problems. Exposure to tobacco has been shown to be associated with higher risk of acquiring TB and adverse outcomes such as relapse and TB mortality.OBJECTIVE: To assess and compare self-reported tobacco quit status and biochemically verified cotinine levels among TB patients at different time intervals among two study groups.METHODS: A cluster, randomised controlled trial was conducted on TB patients attending DOTS centres in Delhi, India, who reported using tobacco in any form. Participants were assigned into one of two treatment groups. Centres were randomly assigned to two intervention groups: 1) integrated intervention using behavioural counselling with nicotine replacement therapy (NRT) gum, and 2) intervention using behavioural counselling alone (50 each in intervention and control group). The subjects were followed at Week 1, Month 1, Month 3 and Month 6 for tobacco cessation.RESULTS: At the end of 6 months, patients who received the integrated intervention had significantly higher rate of success in quitting tobacco than those who received the conventional TB treatment alone (78.7% vs. 57.8%; P < 0.03).CONCLUSION: DOTS with tobacco use dependence treatment was successful in our study in helping TB patients to quit tobacco dependence and should therefore be offered to every tobacco user.

scholarly journals Exercise response in Parkinson’s disease: insights from a cross-sectional comparison with sedentary controls and a per-protocol analysis of a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e017194 ◽  
Author(s):  
Foteini Mavrommati ◽  
Johnny Collett ◽  
Marloes Franssen ◽  
Andy Meaney ◽  
Claire Sexton ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Test ◽  
Controlled Trial ◽  
Exercise Programme ◽  
Incremental Exercise ◽  
Control Group ◽  
Cross Sectional ◽  
Incremental Exercise Test ◽  
Exercise Response ◽  
Randomised Controlled

ObjectivesTo investigate the acute and adaptation cardiovascular and metabolic training responses in people with Parkinson’s disease (pwP).Design(1) A cross-sectional study of exercise response of pwP compared with sedentary controls and (2) an interventional study of exercise training in pwP.SettingCommunity leisure facilities.ParticipantspwP (n=83) and sedentary controls (n=55).InterventionsStudy 1 included participants from a two-arm-parallel single-blind phase II randomised controlled trial (RCT), that undertook a baseline maximal incremental exercise test and study 2 included those randomised to the exercise group in the RCT, who completed a 6-month weekly exercise programme (n=37). The intervention study 2 was a prescribed exercise program consisting of sessions lasting 60 min, two times a week over a 6-month period. The control group followed the same protocol which derived the same cardiorespiratory parameters, except that they were instructed to aim for a cadence of ~60 revolutions per minute and the unloaded phase lasted 3 min with an initial step of 25 W.Primary and secondary outcome measuresStepwise incremental exercise test to volitional exhaustion was the primary outcome measure.ResultsStudy 1 showed higher maximum values for heart rate (HR), VO2L/min, VCO2L/min and ventilation L/min for the control group; respiratory exchange ratio (RER), perceived exertion and O2pulse (VO2L/min/HR) did not differ between groups. In study 2, for pwP who adhered to training (n=37), RER increased significantly and although there was no significant change in aerobic capacity or HR response, reduced blood pressure was found.ConclusionsAn abnormal cardiovascular response to exercise was observed in pwP compared to controls. After the exercise programme, metabolic deficiencies remained for pwP. These observations add to the pathogenic understanding of PD, acknowledge an underling metabolic contribution and support that certain cardiovascular symptoms may improve as a result of this type of exercise.

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