Overview

This trial is active, not recruiting.

Condition geriatric disorder
Treatments grace program, sunbeam program, grace + gait
Phase phase 1
Sponsor Bond University
Start date May 2016
End date December 2016
Trial size 128 participants
Trial identifier NCT02766738, RO1823

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

2. The SUNBEAM program, and

3. The GrACE plus Gait specific training.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
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)
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.
grace program
to compare with the SUNBEAM and 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
(Experimental)
Participants allocated to this intervention group will perform a progressive resistance plus balance training program that will target large muscle groups in the lower- and upper-limbs and trunk, using specialized pneumatic resistance equipment and targeted balance exercises. Sessions will be of 1-hour duration, and will be conducted twice per week over the 24-week period as per Hewitt et al study.
sunbeam program
to compare with the GrACE and 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
(Experimental)
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.
grace + gait
to compare with the GrACE and SUNBEAM 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

Primary Outcomes

Measure
Gait speed and spatio-temporal parameters (in a wider variety of walking tasks)
time frame: change from baseline to 24 weeks

Secondary Outcomes

Measure
Sit to stand performance
time frame: change from baseline to 24 weeks
handgrip strength
time frame: change from baseline to 24 weeks
Body Composition
time frame: change from baseline to 24 weeks
Quality of Life (EQ-5D-EL)
time frame: change from baseline to 24 weeks
Sarcopenia status (SARC-F)
time frame: change from baseline to 24 weeks

Eligibility Criteria

Male or female participants from 65 years up to 100 years old.

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).

Additional Information

Official title Improving Mobility in Residential Aged Care: Comparing the Benefits of Three Resistance Exercise Programs
Principal investigator Justin Keogh, PhD
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, the SUNBEAM and the GrACE plus a gait specific training program. Data Collection One hundred and twenty eight participants from three 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bond University.