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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Timepoint [1] 0 0
change from baseline to 24 weeks
Secondary outcome [1] 0 0
Sit to stand performance
Timepoint [1] 0 0
change from baseline to 24 weeks
Secondary outcome [2] 0 0
handgrip strength
Timepoint [2] 0 0
change from baseline to 24 weeks
Secondary outcome [3] 0 0
Body Composition
Timepoint [3] 0 0
change from baseline to 24 weeks
Secondary outcome [4] 0 0
Quality of Life (EQ-5D-EL)
Timepoint [4] 0 0
change from baseline to 24 weeks
Secondary outcome [5] 0 0
Sarcopenia status (SARC-F)
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
Sex
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
1/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
Accrual to date
Final
84
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/study/NCT02766738
Trial related presentations / publications
Mathiowetz V. Comparison of Rolyan and Jamar dynamometers for measuring grip strength. Occup Ther Int. 2002;9(3):201-9. doi: 10.1002/oti.165.
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. doi: 10.1053/apmr.2001.19778.
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.
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.
Millor N, Lecumberri P, Gomez M, Martinez-Ramirez 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.
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.
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02766738