Feasibility and Benefits of Group Based Exercise in Residential Aged Care Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Geriatric Disorder, Sarcopenia

Intervention / Treatment
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* Other: Exercise
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: the GrACE programme<br>The programme included several 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 GrACE programme was slightly modified for the RAC setting; using reduced range of motion and resistance, and an extended conditioning/familiarisation phase. The conditioning phase lasted for three weeks and focus on the development of correct technique. After concluding the conditioning phase, participants started to use light dumbbells. 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 experienced allied health professional. | Other: Exercise<br>* to determine the feasibility of the GrACE (Group Aged Care Exercise) programme in RAC, with the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength.<br>|
| Placebo Comparator: Control Group<br>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 aerobic exercise and walking, however no specific resistance exercises were offered. | Other: Control<br>* to compare with the GrACE (Group Aged Care Exercise) programme in RAC, as well as the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength against the intervention group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recruitment rate | defined as the number of residents recruited from those invited. Measurement units = number and percentage | up to 12 weeks | 
| measurement (physiological and surveys) completion rate | defined as the number of participants able to complete each outcome measure at baseline and follow-up. Measurement units = number and percentage | up to 12 weeks | 
| loss-to-follow-up | defined as participants who withdrew or dropped out and did not consent to a follow up assessment. Measurement units = number and percentage | up to 12 weeks | 
| exercise session adherence | measured by the number of sessions attended out of the maximum 24 sessions. Measurement units = number and percentage | up to 12 weeks | 
| acceptability | 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 | up to 12 weeks | 
| adverse events | 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 | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Speed | Gait speed was recorded via the GaitMat II system (Manufacturer is EQInc; Model is GaitMat II), which required participants to walk across a level pressure mat system 3.66 m (11.91 ft.) long (McDonough et al. 2001). Participants completed the trials at their preferred (habitual) walking (gait) speed. The following instructions were given, Walk towards the end of the room at a pace that is comfortable for you. Participants were allowed to walk in their own footwear. All measures were initiated from a standing start 2 m (6.56 ft.) from the GaitMat II platform as suggested by Kressig and Beauchet (Kressig & Beauchet 2006) to reduce the effect that acceleration may have on gait speed. The average gait speed (m/s) from three attempts was used for data analysis. Participants were allowed as much rest as required between attempts, with rest periods typically being up to 1 minute. Measurement units = metres per second | change from baseline to 12 weeks | 
| Handgrip strength | Upper body muscle function was measured by isometric handgrip strength and sit-to-stand performance, respectively. When performing the handgrip strength assessments, participants were seated, instructed to keep their elbow at 90° and asked to squeeze a handgrip dynamometer (Sammons Preston Roylan, Bolingbrook, IL) to their maximum ability for a period of up to five seconds (Mathiowetz 2002). Three trials were performed with the subject's dominant hand with one-minute rest between trials and the best result used for analysis (Roberts 2011). Measurement units = kilograms | change from baseline to 12 weeks | 
| Sit to stand performance | In the sit-to-stand measure, participants sat and stood to a full standing position from a chair as many times as possible in 30 seconds whilst keeping their arms crossed against their chest (Millor 2013). Measurement units = repetitions in 30 seconds | change from baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, older adults, physical performance