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A pilot randomised controlled trial of physical activity facilitation for older adults: feasibility study findings.

ABSTRACT: Background:More people are living longer lives leading to a growth in the population of older adults, many of whom have comorbidities and low levels of physical function. Physical activity in later life can prevent or delay age-related disability. Identifying a cost-effective means of increasing physical activity in older adults therefore remains an important public health priority.Physical Activity Facilitation (PAF) is an intervention shown to increase physical activity in adults with depression. The PAF model was modified for a population of older adults at risk of disability. This study aimed to assess the feasibility of undertaking a definitive RCT of the PAF intervention in the target population. Methods:A pilot randomised controlled trial (RCT) was delivered through primary care. Patients at risk of disability and who were not meeting recommended levels of physical activity were recruited through postal invitation and direct approach in the practice waiting room. Those meeting eligibility criteria were enrolled and randomised at a 2:1 ratio to the PAF intervention and control. Behaviour change techniques were used by facilitators with participants over the telephone and face-to-face for 6?months. Outcome measures including physical function, physical activity, depression, social support, and quality of life were collected at baseline and at 6?months. Results:A high proportion of patients responded to the initial invitation (68%), yet many were ineligible due to high levels of self-reported physical activity and baseline physical function. Fifty-one participants were recruited to the trial, with an average age of 74?years (range 65-89), and there were high rates of adherence and retention to the study (94% follow-up at 6?months). The majority of outcome data collected from participants was complete; however, the validated scale used to measure self-reported physical activity was associated with high levels of missing data. Conclusions:The findings of this pilot RCT suggest that it is feasible to deliver a definitive RCT of the PAF intervention in this population. Further work is required to improve the efficiency of recruitment and to minimise missing data from self-reported physical activity measures. Trial registration:Current controlled trials ISRCTN80470273. Registered 25 October 2013.

SUBMITTER: Morgan GS

PROVIDER: S-EPMC6407174 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A pilot randomised controlled trial of physical activity facilitation for older adults: feasibility study findings.

Morgan Gemma S GS Haase Anne M AM Campbell Rona M RM Ben-Shlomo Yoav Y

Pilot and feasibility studies 20190308

<h4>Background</h4>More people are living longer lives leading to a growth in the population of older adults, many of whom have comorbidities and low levels of physical function. Physical activity in later life can prevent or delay age-related disability. Identifying a cost-effective means of increasing physical activity in older adults therefore remains an important public health priority.Physical Activity Facilitation (PAF) is an intervention shown to increase physical activity in adults with ...[more]

PMID: 30891309

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Project description:BackgroundOlder adults living in nursing homes spend the majority of their time inactive. The associated levels of chronic disease place an increasing burden on healthcare systems. Physical activity (PA) interventions delivered through exercise classes may be resource-intensive and require specialist staff. The aim of this study is to explore the feasibility and acceptability of a PA programme embedded into the daily lives of older adults living in nursing homes and to examine the preliminary effects of this on physical mobility and quality of life.MethodsA randomised controlled pilot feasibility study, including embedded qualitative and economic components will be carried out. Two randomly selected nursing homes will take part in the study; participants (n = 20) in one nursing home will receive a three-month PA intervention and participants (n = 20) in the other will be a usual care control. Nursing home staff will be provided with training and support to monitor participants PA programmes. Feasibility data will be collected on recruitment, randomisation, assessment and intervention procedures. Criteria for progression of the pilot feasibility study to a definitive trial will be specified. The Timed Up and Go test, Nottingham Health Profile, 10-Metre Walk test, the Investigating Choice Experiments for the Preferences of Older People Capability index and the Bangor Goal Setting Interview will be assessed at baseline, three-month and 12-month follow-up. Between-group and within-individual effects will be estimated using appropriate linear mixed models. Semi-structured interviews will be conducted with staff and participants of the intervention group within one month after the intervention to explore the feasibility and acceptability of the programme. A subset of control participants will be interviewed to describe usual care. Economic data will be collected to examine costs of the intervention in comparison with costs in the control group.DiscussionThe findings will facilitate refinement of the PA programme and development of a clear protocol for subsequent evaluation of the PA intervention in a definitive randomised controlled trial.Trial registrationClinicalTrials.gov, NCT03484715 . Registered on 30 March 2018.

Project description:BackgroundLow quality social relationships in older adults are strongly associated with feelings of loneliness. Physical activity interventions could reduce loneliness and improve psychological well-being, among other health benefits. The aim of this study was to examine the feasibility of a Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults at risk of loneliness.MethodsThe PAIL feasibility study was a 12-week randomized controlled feasibility trial (RCT) conducted in Birmingham, United Kingdom, from February 2018 to August 2018, and ran in two waves of data collection. Eligible participants were community-dwelling adults aged 60 years and older, sedentary (less than 20 min of moderate-to-vigorous PA (MVPA) a week), and at risk of loneliness. The intervention included once-weekly group walk and health education workshop up to 90 min per session in total, with a wait-listed (WL) control group. The primary feasibility outcomes were to estimate recruitment, retention rates and adherence to the intervention. Secondary outcome measures (not blinded assessment) were body mass index, blood pressure, physical activity and psychosocial variables. Process and outcome evaluations were conducted using focus groups interviews. The recruitment and retention progression criteria for the definitive large-scale RCT was set a-priori.ResultsForty-eight participants were recruited over 4 months with a recruitment rate of 25% (48/195); 52% (25/48) met the inclusion criteria and 100% (25/25) were randomised into the intervention (n = 12) and WL control groups (n = 13). Participants were 25 older adults (mean (SD) 68.5(8.05) years), 14 (56%) female, and 18 (72%) white. At 12 weeks, 10/12 (83.3%) intervention and 10/13 (76.9%) control participants completed the final assessments. The average attendance rate was 58.3% for the intervention group (range 33.0%-75.0%) and 42.3% (range 23.1%-69.2%) among controls. The a priori recruitment and retention criteria for progression were not met. No serious adverse events occurred. The focus group results identified three themes which showed overall positive experiences of participation in PAIL in terms of (1) study design and intervention; (2) walking sessions; and (3) health education workshops.ConclusionsThe findings suggest that community-dwelling older adults at risk of loneliness found the intervention and measures acceptable and could safely participate. However, a more extensive and robust strategy would be needed to support adequate recruitment of lonely older adults and adherence into a definitive RCT.Trial registrationClinicaltrials.gov, NCT03458793.

Project description:BackgroundUntreated heterozygous familial hypercholesterolaemia (FH) causes high low-density lipoprotein cholesterol (LDL-C) levels and increased cardiovascular disease (CVD) risk. Despite pharmacological treatment, many treated individuals remain at higher CVD risk than non-affected individuals. This may be due to LDL-C targets not being met and presence of other CVD risk factors. Adhering to dietary and physical activity (PA) recommendations developed for individuals with FH may further reduce CVD risk. However, there is insufficient research to support the efficacy of adhering to these guidelines on LDL-C and other CVD risk factors. The need for studies to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended. This paper describes the protocol of a pilot, randomised controlled trial designed to evaluate the feasibility and acceptability of a specifically developed nutrition and PA intervention aimed at improving the dietary intakes and PA levels of families with FH.MethodsA two-arm randomised waitlist-controlled pilot trial will be conducted across three National Health Service (NHS) sites in England, UK. Twenty-four young people with FH, aged 10-18 years, and their affected parent, will be recruited and randomly assigned to the intervention or waitlist and usual care control. The primary aim is to provide evidence for the feasibility and acceptability of delivering the intervention, explored quantitatively (rates of recruitment, retention and outcome measure completeness) and qualitatively (qualitative interviews). The secondary aim is to provide evidence for the potential efficacy of the intervention on dietary intake, PA, sedentary time, body composition, CVD risk factors and quality of life determined at baseline and endpoint assessments. The intervention will involve an hour-long consultation with a dietitian at baseline and four follow-up contacts across the 12-week intervention. It has been specifically developed for use with individuals with FH and incorporates behavioural change techniques to target identified enablers and barriers to adherence in this population.DiscussionThis trial will estimate the feasibility and acceptability of the nutrition and PA intervention delivered to young people and parents with FH. If appropriate, this study can be used to inform the design of an adequately powered definitive trial.Trial registrationISRCTN, ISRCTN24880714. Registered 07/06/2018, http://www.isrctn.com/ISRCTN24880714.

Project description:BACKGROUND:As adults age, their physical activity decreases and sedentary behavior increases, leading to increased risk of negative health outcomes. Wearable electronic activity monitors have shown promise for delivering effective behavior change techniques. However, little is known about the feasibility and acceptability of non-Fitbit wearables (Fitbit, Inc, San Francisco, California) combined with telephone counseling among adults aged more than 55 years. OBJECTIVE:The purpose of our study was to determine the feasibility, acceptability, and effect on physical activity of an intervention combining a wearable physical activity monitor, tablet device, and telephone counseling among adults aged 55-79 years. METHODS:Adults (N=40, aged 55-79 years, body mass index=25-35, <60 min of activity per week) were randomized to receive a 12-week intervention or to a wait list control. Intervention participants received a Jawbone Up24 monitor, a tablet with the Jawbone Up app installed, and brief weekly telephone counseling. Participants set daily and weekly step goals and used the monitor's idle alert to notify them when they were sedentary for more than 1 h. Interventionists provided brief counseling once per week by telephone. Feasibility was measured using observation and study records, and acceptability was measured by self-report using validated items. Physical activity and sedentary time were measured using ActivPAL monitors following standard protocols. Body composition was measured using dual-energy x-ray absorptiometry scans, and fitness was measured using a 6-min walk test. RESULTS:Participants were 61.48 years old (SD 5.60), 85% (34/40) female, 65% (26/40) white. Average activity monitor wear time was 81.85 (SD 3.73) of 90 days. Of the 20 Up24 monitors, 5 were reported broken and 1 lost. No related adverse events were reported. Acceptability items were rated at least 4 on a scale of 1-5. Effect sizes for most outcomes were small, including stepping time per day (d=0.35), steps per day (d=0.26), sitting time per day (d=0.21), body fat (d=0.17), and weight (d=0.33). CONCLUSIONS:The intervention was feasible and acceptable in this population. Effect sizes were similar to the sizes found using other wearable electronic activity monitors, indicating that when combined with telephone counseling, wearable activity monitors are a potentially effective tool for increasing physical activity and decreasing sedentary behavior. TRIAL REGISTRATION:Clinicaltrials.gov NCT01869348; https://clinicaltrials.gov/ct2/show/NCT01869348 (Archived by WebCite at http://www.webcitation.org/6odlIolqy).

Project description:BackgroundInteractive web-based physical activity interventions using Web 2.0 features (e.g., social networking) have the potential to improve engagement and effectiveness compared to static Web 1.0 interventions. However, older adults may engage with Web 2.0 interventions differently than younger adults. The aims of this study were to determine whether an interaction between intervention (Web 2.0 and Web 1.0) and age group (<55y and ≥55y) exists for website usage and to determine whether an interaction between intervention (Web 2.0, Web 1.0 and logbook) and age group (<55y and ≥55y) exists for intervention effectiveness (changes in physical activity).MethodsAs part of the WALK 2.0 trial, 504 Australian adults were randomly assigned to receive either a paper logbook (n = 171), a Web 1.0 (n = 165) or a Web 2.0 (n = 168) physical activity intervention. Moderate to vigorous physical activity was measured using ActiGraph monitors at baseline 3, 12 and 18 months. Website usage statistics including time on site, number of log-ins and number of step entries were also recorded. Generalised linear and intention-to-treat linear mixed models were used to test interactions between intervention and age groups (<55y and ≥55y) for website usage and moderate to vigorous physical activity changes.ResultsTime on site was higher for the Web 2.0 compared to the Web 1.0 intervention from baseline to 3 months, and this difference was significantly greater in the older group (OR = 1.47, 95%CI = 1.01-2.14, p = .047). Participants in the Web 2.0 group increased their activity more than the logbook group at 3 months, and this difference was significantly greater in the older group (moderate to vigorous physical activity adjusted mean difference = 13.74, 95%CI = 1.08-26.40 min per day, p = .03). No intervention by age interactions were observed for Web 1.0 and logbook groups.ConclusionsResults partially support the use of Web 2.0 features to improve adults over 55 s' engagement in and behaviour changes from web-based physical activity interventions.Trial registrationACTRN ACTRN12611000157976 , Registered 7 March 2011.

Project description:ObjectiveThe objective of this study was to determine the feasibility and effectiveness of using SUpported Motivational InTerviewing (SUMIT) to increase physical activity in people with knee osteoarthritis (KOA).DesignRandomised controlled trial.SettingWe recruited people who had completed Good Life with osteoArthritis Denmark (GLA:D) from private, public and community settings in Victoria, Australia.InterventionsParticipants were randomised participants to receive SUMIT or usual care. SUMIT comprised five motivational interviewing sessions targeting physical activity over 10 weeks, and access to a multimedia web-based platform.ParticipantsThirty-two participants were recruited (17 SUMIT, 15 control) including 22 females (69%).Outcome measuresFeasibility outcomes included recruitment rate, adherence to motivational interviewing, ActivPAL wear and drop-out rate. Effect sizes (ESs) were calculated for daily steps, stepping time, time with cadence >100 steps per minute, time in bouts >1 min; 6 min walk distance, Knee Osteoarthritis Outcome Score (KOOS) subscales (pain, symptoms, function, sport and recreation, and quality of life (QoL)), Euroqual, systolic blood pressure, body mass index, waist circumference, 30 s chair stand test and walking speed during 40 m walk test.ResultsAll feasibility criteria were achieved, with 32/63 eligible participants recruited over seven months; with all participants adhering to all motivational interviewing calls and achieving sufficient ActivPAL wear time, and only two drop-outs (6%).12/15 outcome measures showed at least a small effect (ES>0.2) favouring the SUMIT group, including daily time with cadence >100 steps per minute (ES=0.43). Two outcomes, walking speed (ES= 0.97) and KOOS QoL (ES=0.81), showed a large effect (ES>0.8).ConclusionSUMIT is feasible in people with knee osteoarthritis. Potential benefits included more time spent walking at moderate intensity, faster walking speeds and better QoL.Trial registration numberACTRN12621000267853.

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A pilot randomised controlled trial of physical activity facilitation for older adults: feasibility study findings.

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A pilot randomised controlled trial of physical activity facilitation for older adults: feasibility study findings.

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