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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Improving Mobility in Residential Aged Care: Comparing the Benefits of Two Resistance Exercise Programs
Secondary ID [1] 0 0
RO1823
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geriatric Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gait speed and spatio-temporal parameters (in a wider variety of walking tasks) - 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).
Timepoint [1] 0 0
change from baseline to 24 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
change from baseline to 24 weeks
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
change from baseline to 24 weeks
Secondary outcome [3] 0 0
Body Composition - measure the volume of lean body mass (kg) and fat mass (kg) and the skeletal muscle index will be calculated using the BIA.
Timepoint [3] 0 0
change from baseline to 24 weeks
Secondary outcome [4] 0 0
Quality of Life (EQ-5D-EL) - 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.
Timepoint [4] 0 0
change from baseline to 24 weeks
Secondary outcome [5] 0 0
Sarcopenia status (SARC-F) - 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.
Timepoint [5] 0 0
change from baseline to 24 weeks

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).
Minimum age
65 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Darlington RSL Care - Tweed Heads
Recruitment postcode(s) [1] 0 0
2486 - Tweed Heads

Funding & Sponsors
Primary sponsor type
Other
Name
Bond University
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02766738
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Justin Keogh, PhD
Address 0 0
Bond University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications