Clinical trial NCT02766738: Improving Mobility in Residential Aged Care
Official title: Improving Mobility in Residential Aged Care: Comparing the Benefits of Two Resistance Exercise Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Disorder
Keywords: residential aged care
mobility
social participation
functional capability
Lead sponsor: Bond University
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study aims to test which of three exercise programs, previously demonstrated valuable for residential aged care adults, has the greatest benefit for walking speed and the spatiotemporal parameters that define it. The programs to be included are:

1. The GrACE program and
2. The GrACE plus Gait specific training.

Detailed description: This study will employ a non-randomised controlled design in which three different 24-week exercise programs and a non-exercising control group will be compared in the residential aged care (RAC) setting. The three programs are the GrACE and the GrACE plus a gait specific training program.

Data Collection

\~40 participants from two RAC facilities will be recruited into the study. This number of participants will provide 80% statistical power to identify moderate effect size between group differences on the primary outcome measures. The control group will be drawn from each of the RAC facility approached receiving exercise treatment. Participation will be informed by a discussion with the facilities Service Manager about the eligibility of participants and a medical history screen undertaken. All participants will provide informed written consent prior to participation.

Participants in the exercise group will perform twice weekly training for 24 weeks. Data will be collected at 0 weeks, 12 weeks and 24 weeks in the control and exercise groups.

Eligibility criteria: Inclusion Criteria:

* aged over 65 years
* residing in a RAC facility
* able to walk with a walker and/or walking stick or can self-ambulate for the test (including those who have had knee and hip replacements)
* can provide informed consent (Self- or by proxy).

Exclusion Criteria:

* end-stage terminal and/or life expectancy \<6-months (ethical reasons)
* two person transfer or unable to self-ambulate (increased falls risk)
* unable to communicate or follow instructions (personal needs beyond the scope of this project)
* dangerous behaviours (endanger the client or research staff).

Primary outcomes:
measure: Gait speed and spatio-temporal parameters (in a wider variety of walking tasks)
timeFrame: change from baseline to 24 weeks
Secondary outcomes:
measure: Sit to stand performance
timeFrame: change from baseline to 24 weeks
measure: handgrip strength
timeFrame: change from baseline to 24 weeks
measure: Body Composition
timeFrame: change from baseline to 24 weeks
measure: Quality of Life (EQ-5D-EL)
timeFrame: change from baseline to 24 weeks
measure: Sarcopenia status (SARC-F)
timeFrame: change from baseline to 24 weeks
Other outcomes:
Locations:
city: Tweed Heads
country: Australia
facility: Darlington RSL Care
state: New South Wales
Study officials:
affiliation: Bond University
name: Justin Keogh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1007/BF03327437.
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citation: Taylor ME, Delbaere K, Mikolaizak AS, Lord SR, Close JC. Gait parameter risk factors for falls under simple and dual task conditions in cognitively impaired older people. Gait Posture. 2013 Jan;37(1):126-30. doi: 10.1016/j.gaitpost.2012.06.024. Epub 2012 Jul 23.
citation: Hewitt J, Refshauge KM, Goodall S, Henwood T, Clemson L. Does progressive resistance and balance exercise reduce falls in residential aged care? Randomized controlled trial protocol for the SUNBEAM program. Clin Interv Aging. 2014 Feb 21;9:369-76. doi: 10.2147/CIA.S53931. eCollection 2014.