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
Verified date | December 2015 |
Source | Bond University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Human Research Ethics Committee |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Bond University |
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
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 |
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