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Improving Mobility in Residential Aged Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02766738
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Samantha Fien, Bond University

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.

Condition or disease Intervention/treatment Phase
Geriatric Disorder Other: GrACE program Other: GrACE + gait Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Mobility in Residential Aged Care: Comparing the Benefits of Two Resistance Exercise Programs
Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Arm Intervention/treatment
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.
Other: 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

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: 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




Primary Outcome Measures :
  1. Gait speed and spatio-temporal parameters (in a wider variety of walking tasks) [ Time Frame: change from baseline to 24 weeks ]
    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).


Secondary Outcome Measures :
  1. Sit to stand performance [ Time Frame: change from baseline to 24 weeks ]
    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

  2. handgrip strength [ Time Frame: change from baseline to 24 weeks ]
    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

  3. Body Composition [ Time Frame: change from baseline to 24 weeks ]
    measure the volume of lean body mass (kg) and fat mass (kg) and the skeletal muscle index will be calculated using the BIA.

  4. Quality of Life (EQ-5D-EL) [ Time Frame: change from baseline to 24 weeks ]
    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.

  5. Sarcopenia status (SARC-F) [ Time Frame: change from baseline to 24 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766738


Locations
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Australia, New South Wales
Darlington RSL Care
Tweed Heads, New South Wales, Australia, 2486
Sponsors and Collaborators
Bond University
Investigators
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Principal Investigator: Justin Keogh, PhD Bond University
Publications of Results:

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Responsible Party: Samantha Fien, PhD Student, Bond University
ClinicalTrials.gov Identifier: NCT02766738    
Other Study ID Numbers: RO1823
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Samantha Fien, Bond University:
residential aged care
mobility
social participation
functional capability