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

Sarcopenia Clinical Trial

Official title:

Feasibility and Benefits of Group Based Exercise in Residential Aged Care Adults: a Randomised Control Trial for the GrACE Programme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640963
• Other study ID #: RO 1823
• Status: Completed
• Phase: N/A
• First received: December 15, 2015
• Last updated: December 28, 2015
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: Bond University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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 and were randomised into 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 100 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Geriatric Disorder
• Sarcopenia

Intervention

Other:
• Exercise
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.
• Control
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bond University

References & Publications (8)

Henwood T, Wooding A, and de Souza D. 2013. Centre-based exercise delivery: feasability of a staff-delivered program and the benefits for low-functioning older adults accessing respite day care. Activities, Adaptations & Ageing 73:224-238.

Henwood TR, Keogh JW, Reid N, Jordan W, Senior HE. Erratum to: Assessing sarcopenic prevalence and risk factors in residential aged care: methodology and feasibility. J Cachexia Sarcopenia Muscle. 2014 Sep;5(3):237. doi: 10.1007/s13539-014-0151-0. — View Citation

Kressig RW, Beauchet O; European GAITRite Network Group. Guidelines for clinical applications of spatio-temporal gait analysis in older adults. Aging Clin Exp Res. 2006 Apr;18(2):174-6. — View Citation

Mathiowetz V. Comparison of Rolyan and Jamar dynamometers for measuring grip strength. Occup Ther Int. 2002;9(3):201-9. — View Citation

McDonough AL, Batavia M, Chen FC, Kwon S, Ziai J. The validity and reliability of the GAITRite system's measurements: A preliminary evaluation. Arch Phys Med Rehabil. 2001 Mar;82(3):419-25. — View Citation

Millor N, Lecumberri P, Gómez M, Martínez-Ramírez A, Izquierdo M. An evaluation of the 30-s chair stand test in older adults: frailty detection based on kinematic parameters from a single inertial unit. J Neuroeng Rehabil. 2013 Aug 1;10:86. doi: 10.1186/1743-0003-10-86. — View Citation

Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30. Review. — View Citation

Sterke CS, van Beeck EF, Looman CW, Kressig RW, van der Cammen TJ. An electronic walkway can predict short-term fall risk in nursing home residents with dementia. Gait Posture. 2012 May;36(1):95-101. doi: 10.1016/j.gaitpost.2012.01.012. Epub 2012 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recruitment rate	defined as the number of residents recruited from those invited. Measurement units = number and percentage	up to 12 weeks	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes

External Links

•   study involving community dwelling older adults