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Clinical Trials/NCT02640963
NCT02640963
Completed
Not Applicable

Feasibility and Benefits of Group Based Exercise in Residential Aged Care Adults: a Pilot Study for the GrACE Programme

Bond University0 sites37 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Geriatric Disorder
Sponsor
Bond University
Enrollment
37
Primary Endpoint
recruitment rate
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This study is a pilot study (feasibility and acceptability study), which will compare feasibility and efficacy outcomes between a 12-week Exercise Program and control group in RAC residents.

Detailed Description

Study Design and Recruitment This study compared the delivery feasibility and outcomes of a 12-week combined resistance and weight bearing exercise programme which the investigators named the GrACE programme. Participant recruitment and assessment occurred over a five-month period. The RAC was approached about participation via email and telephone follow-up. Potential participants were identified at a meeting with the facility Service Manager. Participants were screened via the inclusion criteria at the meeting with the Service Manager and a Registered Nurse, and written consent was attained prior to participation. Following an explanation of the procedures, purposes, benefits and associated risks of the study, participants had the opportunity to ask questions. A total of 37 older RAC adults provided written informed consent for the study. The exercise group contained 20 participants and the control group 17 participants. Ethical approval to conduct this study was attained from Bond University's Human Ethics Research Committee (RO 1823). Intervention: the GrACE programme Previous work by our group trialled a successful exercise programme in respite day care that could promise benefits to those in RAC (HenwoodWooding \& de Souza 2013). In brief, the GrACE programme included a number of targeted weight-bearing exercises (using body weight and dumbbells) and a range of seated, non-resisted upper- and lower-body dynamic and reaching movements. While developed for respite care older adults, the programme was slightly modified for the RAC setting; initially using reduced range of motion and resistance, and an extended conditioning/familiarisation phase. The conditioning phase lasted for three weeks in which technique was emphasised without using any weights or additional resistance. The focus of this technique of the conditioning phase was to develop the correct technique and minimise the potential for any delayed onset muscle soreness or adverse effects. After concluding the conditioning phase, participants were able to use light dumbbells (often starting with 0.5kg) increasing to heavier dumbbells (up to 4kg) with their increasing capacity over the course of the programme. Participants performed the exercises twice per week for 12 weeks. Training sessions lasted approximately 45 minutes, were separated by at least 48 hours and were delivered by an allied health professional experienced working with RAC adults. Control Group All subjects assigned to the control group were given the option to engage in other activities that were offered by the facility during the 12-week intervention period. Activities were facility specific, and included Zumba Gold aerobic exercise and walking, however no specific resistance exercises were offered. Data Collection Reasons for refusal (non-consent) to participate were recorded (Henwood 2014). All muscle function outcome measures in this study have been previously validated for use with older adults, and their protocols reported elsewhere (Henwood, Wooding \& de Souza 2013; Sterke et al. 2012). Assessments were completed one-on-one with each participant. During muscle function measures assessments, participants were encouraged to rest as needed and given verbal support and encouragement to reduce any potential burden to the participant.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bond University
Responsible Party
Principal Investigator
Principal Investigator

Samantha Fien

Student

Bond University

Eligibility Criteria

Inclusion Criteria

  • Aged 65 years and over,
  • Residing in a RAC,
  • Able to walk with a walker and/or walking stick or could self-ambulate and,
  • Could provide informed consent.

Exclusion Criteria

  • End-stage terminal and/or life expectancy \<6-months (ethical reasons),
  • Two person transfer or unable to self-ambulate (due to increased falls risk),
  • Unable to communicate or follow instructions (personal needs beyond the scope of this project),
  • Insufficient cognitive function to provide informed consent and,
  • Dangerous behaviours that would endanger the client or research staff.

Outcomes

Primary Outcomes

recruitment rate

Time Frame: up to 12 weeks

defined as the number of residents recruited from those invited. Measurement units = number and percentage

exercise session adherence

Time Frame: up to 12 weeks

measured by the number of sessions attended out of the maximum 24 sessions. Measurement units = number and percentage

adverse events

Time Frame: up to 12 weeks

defined as incidents in which harm or damage resulted to a participant and included, but were not limited to, falls and fall-related injuries, musculoskeletal or cardiovascular incidents and problems with medication and medical devices. Measurement units = number and percentage

measurement (physiological and surveys) completion rate

Time Frame: up to 12 weeks

defined as the number of participants able to complete each outcome measure at baseline and follow-up. Measurement units = number and percentage

loss-to-follow-up

Time Frame: up to 12 weeks

defined as participants who withdrew or dropped out and did not consent to a follow up assessment. Measurement units = number and percentage

acceptability

Time Frame: up to 12 weeks

measured via a programme satisfaction survey completed post-training that assessed the burden of training and testing, as well as how participants felt about the trial. Measurement units = number and percentage

Secondary Outcomes

  • Sit to stand performance(change from baseline to 12 weeks)
  • Gait Speed(change from baseline to 12 weeks)
  • Handgrip strength(change from baseline to 12 weeks)

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