Geriatric DisorderNCT02766738
Improving Mobility in Residential Aged Care
A study testing GrACE program and GrACE + gait in people with Geriatric Disorder, run by Bond University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Geriatric Disorder
- What is being tested?
- GrACE program and GrACE + gait
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteAustralia
- Study dates
- May 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Mobility in Residential Aged Care: Comparing the Benefits of Two Resistance Exercise Programs
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:
- The GrACE program and
- The GrACE plus Gait specific training.
Read the 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.
- Conditions
- Geriatric Disorder
- Being tested
- GrACE program, GrACE + gait
- Keywords
- residential aged care, mobility, social participation, functional capability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrACE programOther
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
GrACE + gaitOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control | 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. |
| GrACE program | 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. Receives: Other: GrACE program |
| GrACE + gait program | 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. Receives: Other: GrACE + gait |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: change from baseline to 24 weeks
Secondary outcomes (5)
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
Measured: change from baseline to 24 weeks
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
Measured: change from baseline to 24 weeks
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.
Measured: change from baseline to 24 weeks
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.
Measured: change from baseline to 24 weeks
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.
Measured: change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Geriatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bond University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Fien, Bond University
- Investigators
- Justin Keogh, PhD, Principal investigator, Bond University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766738
- Sponsor's protocol ID
- RO1823
- Status last verified
- May 2017
- First submitted
- 6 May 2016
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 12374997McDonough 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.
PubMed 11245768Kressig 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.
PubMed 16702791Roberts 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.
PubMed 21624928Millor 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.
PubMed 24059755Taylor 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.
PubMed 22832468Hewitt 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.
PubMed 24591821
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mobility in Residential Aged Care: Comparing the Benefits of Two Resistance Exercise Programs
- ClinicalTrials.gov ID
- NCT02766738
- Acronym / sponsor ID
- RO1823
- Conditions
- Geriatric Disorder
- Keywords
- residential aged care, mobility, social participation, functional capability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Bond UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The GrACE program and
- The GrACE plus Gait specific training.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | 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. |
| GrACE program | Experimental | Other: GrACE programParticipants 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 + gait program | Experimental | Other: GrACE + gaitGrACE 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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrACE programto 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 | GrACE program |
| GrACE + gaitto 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 | Other | GrACE + gait program |
Primary outcome
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).
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Results publication: PubMed 12374997Mathiowetz V. Comparison of Rolyan and Jamar dynamometers for measuring grip strength. Occup Ther Int. 2002;9(3):201-9. doi: 10.1002/oti.165.
- Results publication: PubMed 11245768McDonough 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.
- Results publication: PubMed 16702791Kressig 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.
- Results publication: PubMed 21624928Roberts 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.
- Results publication: PubMed 24059755Millor 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.
- Results publication: PubMed 22832468Taylor 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.
- Results publication: PubMed 24591821Hewitt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Keogh, PhD principal investigator
Bond University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GrACE program and GrACE + gait in people with Geriatric Disorder, run by Bond University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed and spatio-temporal parameters (in a wider variety of walking tasks) (time frame: change from baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02766738, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.