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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02766738
Registration number
NCT02766738
Ethics application status
Date submitted
6/05/2016
Date registered
10/05/2016
Date last updated
8/05/2017
Titles & IDs
Public title
Improving Mobility in Residential Aged Care
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Scientific title
Improving Mobility in Residential Aged Care: Comparing the Benefits of Two Resistance Exercise Programs
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Secondary ID [1]
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RO1823
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Geriatric Disorder
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - GrACE program
Other interventions - GrACE + gait
No Intervention: Control - All participants assigned to the control group will be given the option to engage in other activities that were offered by the facility during the 24-week intervention period. However, no specific resistance exercises were offered in these activities.
Experimental: GrACE program - Participants in the exercise group will perform twice weekly training for 24 weeks. In brief, the program will include weight-bearing exercises and a range of seated, non-resisted upper- and lower-body dynamic and reaching movements. The following-weight bearing and resistance exercises: chair stands, chair dips, calf raises and hip flexor/abdominal lifts, trunk twists, and bicep curl and shoulder press. In total the sessions will be 45 minutes twice weekly.
Experimental: GrACE + gait program - GrACE program as mentioned above plus focus on gait specific training will be one-hour training sessions for 24 weeks. Gait exercises will be a combination of exercises: heel and toe raises, stepping in different directions, single leg stand¬ing, step-ups, and task-specific balance work (e.g. reaching outward from the base of support while standing, sitting, and standing and turning). Gait exercises will be upgraded by: 1) reducing hand support and/or 2) narrowing the base of support, and/or 3) introducing a cognitive challenge (e.g. counting backwards while performing exercise) or perform¬ing exercise with the eyes closed.
Other interventions: GrACE program
to compare with the GrACE + gait 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 and control group
Other interventions: GrACE + gait
to compare with the GrACE 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 and control group
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Gait speed and spatio-temporal parameters (in a wider variety of walking tasks)
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Assessment method [1]
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Gait speed and spatio-temporal parameters will be 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. All measures will be 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. Three conditions will be measured which include normal walking, along with two dual tasks. These dual tasks include: (i) walking while carrying a glass of water in the participants preferred hand, (ii) walking while counting backwards from 30. Each of these gait conditions will be performed for three repetitions in a randomised block order (Taylor, 2012).
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Timepoint [1]
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change from baseline to 24 weeks
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Secondary outcome [1]
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Sit to stand performance
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Assessment method [1]
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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
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Timepoint [1]
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change from baseline to 24 weeks
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Secondary outcome [2]
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handgrip strength
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Assessment method [2]
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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
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Timepoint [2]
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change from baseline to 24 weeks
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Secondary outcome [3]
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Body Composition
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Assessment method [3]
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measure the volume of lean body mass (kg) and fat mass (kg) and the skeletal muscle index will be calculated using the BIA.
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Timepoint [3]
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change from baseline to 24 weeks
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Secondary outcome [4]
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Quality of Life (EQ-5D-EL)
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Assessment method [4]
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The EQ-5D-EL descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems.
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Timepoint [4]
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change from baseline to 24 weeks
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Secondary outcome [5]
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Sarcopenia status (SARC-F)
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Assessment method [5]
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The SARC-F questionnaire is a rapid diagnostic test used to screen individuals for sarcopenia. There are five SARC components: strength, assistance with walking, rising from a chair, climbing stairs, and falls. The scores range from 0 to 2 points for each of the five components, allowing a total score of 0-10. Studies have suggested that a score equal to or greater than four is predictive of sarcopenia and poor health outcomes.
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Timepoint [5]
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change from baseline to 24 weeks
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Eligibility
Key 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).
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Minimum age
65
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2017
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Sample size
Target
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Accrual to date
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Final
84
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Darlington RSL Care - Tweed Heads
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Recruitment postcode(s) [1]
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2486 - Tweed Heads
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bond University
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02766738
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Justin Keogh, PhD
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Address
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Bond University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02766738
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