Mobility LimitationMOVENCT01474616
Mobility of Vulnerable Elders (MOVE): Translating Knowledge to Health Care Aides in Long-term Care Facilities
A study testing Sit-to-Stand Activity in people with Mobility Limitation, run by University of Alberta at 4 sites in Canada.
Trial summary
Almost 90 percent of residents living in long-term care facilities have some type of mobility limitation, which worsens quickly once they move into a long-term care facility. This means that they cannot easily walk or move around in their day-to-day lives and this can have serious consequences for their general health… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Sit-to-Stand Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 4 sitesCanada
- Study dates
- Aug 2011to Jun 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- have a diagnosis of Alzheimer disease, vascular dementia, or mixed dementia
- are able to transfer independently or with the assistance of one person
Who cannot join
- have a diagnosis of fronto-temporal or Lewy-body dementia
- require the assistance of more than one person to transfer, or a transfer lift
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
CapitalCare Continuing Care
Edmonton, Alberta, T5J 3M9
Good Samaritan Society
Edmonton, Alberta, T6C 4G8
Extendicare
Edmonton, Alberta, T6E 6A8
Shepherd's Care Foundation
Edmonton, Alberta, T6K 2R1
About this study
Almost 90 percent of residents living in long-term care facilities have some type of mobility limitation, which worsens quickly once they move into a long-term care facility. This means that they cannot easily walk or move around in their day-to-day lives and this can have serious consequences for their general health and well-being. Researchers have shown that exercise can help the mobility of even the oldest of adults but elderly residents in long-term care facilities still commonly sit or lie in bed for long periods of time, in many cases for most of their waking hours. The purpose of this research is to study the effect of a simple physical activity on the mobility and quality of life of residents in long-term care facilities. Researchers will introduce a sit-to-stand activity to health care aides which will become part of their daily routine with residents. The basic sit-to-stand movement is already a part of the daily activities that health care aides do with residents. Specifically, health care aides will ask residents to repeat the sit-to-stand activity at mealtimes, when using the toilet, and on other occasions of daily activity. An important part of this research is to find out how well the activity preserves the ability of residents to stay mobile and also to examine how this will improve their quality of life in the home. The MOVE study will demonstrate whether it is possible to delay the loss of mobility in long-term care residents by incorporating the sit-to-stand activity into the regular practice of health care aides.
- Conditions
- Mobility Limitation
- Being tested
- Sit-to-Stand Activity
- Keywords
- Aging, Health Services, Knowledge Translation, Long-Term Care Facilities, Mobility, Psychosocial And Health Behaviours
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit-to-Stand ActivityOther
Health care aides will be expected to prompt residents to repeatedly stand up and sit down on four occasions throughout the day (twice on each of the day and evening shifts). The number of repetitions on each occasion will vary according to residents' ability and fatigue. The sit-to-stand activity is to be integrated into usual care routines such as when entering the dining room at mealtimes, while toileting, and on other occasions of regular activity. The timing and location will be at the discretion of the health care aide.
| Study group | Role | What they receive |
|---|---|---|
| Sit-to-Stand Activity | Other | Not described Receives: Other: Sit-to-Stand Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Mobility at 3 and 6 months
The sit-to-stand action is a functional activity that has been incorporated into a number of mobility measures. We have chosen to measure mobility using the number of sit-to-stands in 30 seconds because in the frail nursing home population many residents have difficulty transferring (e.g.standing up from a chair). In our pilot study we found many residents were unable to complete more than two or three sit-to-stands. Residents will be instructed to stand up and sit down as many times as possible until they are asked to stop after 30 seconds (Jones, Rikli, \& Beam, 1999).
Measured: Baseline, 3-Months, 6-Months
Secondary outcomes (3)
Change from Baseline in Function at 3 and 6 months
The Functional Independence Measure (FIM) is an 18-item performance-based instrument which assesses the amount of assistance required to complete basic activities of daily living using a 7-point scale graded from 1 (dependent) to 7 (independent) (Jones \& Feeny, 2006).
Measured: Baseline, 3-Months, 6-Months
Change from Baseline in Health Related Quality of Life at 3 and 6 months
The Health Utilities Index Mark 2 and 3 (HUI2/3) is a generic health related quality of life questionnaire based on two generic multi-attribute preference-based systems: the HUI2 and the HUI3. The HUI2 assesses capacity on six dimensions (or attributes) of health status: sensation (vision, hearing, and speech), mobility, emotion, cognition, self-care, and pain. The HUI3 consists of eight attributes: vision; hearing; speech; ambulation; dexterity; emotion; cognition; and, pain (Furlong, et al., 2011).
Measured: Baseline, 3-Months, 6-Months
Change from Baseline in Dementia Specific Quality of Life at 3 and 6 Months
The Quality of Life-Alzheimer's Disease (QofL-AD) was developed to capture the domains considered important to quality of life in Lawton's broad conceptual framework: the interpersonal; environmental; functional; physical; and, psychological domains. The 13 items including physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, fun, money, life as a whole scored on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent) (Lawton, 1983; 1991).
Measured: Baseline, 3-Months, 6-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), CapitalCare Continuing Care, Extendicare, Good Samaritan Society, Shepherd's Care Foundation
- Responsible party
- Sponsor
- Investigators
- Susan Slaughter, RN, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474616
- Sponsor's protocol ID
- DPA 108891
- Acronym
- MOVE
- Status last verified
- Jul 2013
- First submitted
- 10 Nov 2011
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Slaughter SE, Wagg AS, Jones CA, Schopflocher D, Ickert C, Bampton E, Jantz A, Milke D, Schalm C, Lycar C, Estabrooks CA. Mobility of Vulnerable Elders study: effect of the sit-to-stand activity on mobility, function, and quality of life. J Am Med Dir Assoc. 2015 Feb;16(2):138-43. doi: 10.1016/j.jamda.2014.07.020. Epub 2014 Sep 27.
PubMed 25271194Slaughter SE, Estabrooks CA, Jones CA, Wagg AS. Mobility of Vulnerable Elders (MOVE): study protocol to evaluate the implementation and outcomes of a mobility intervention in long-term care facilities. BMC Geriatr. 2011 Dec 16;11:84. doi: 10.1186/1471-2318-11-84.
PubMed 22176583
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility of Vulnerable Elders (MOVE): Translating Knowledge to Health Care Aides in Long-term Care Facilities
- ClinicalTrials.gov ID
- NCT01474616
- Acronym / sponsor ID
- MOVE / DPA 108891
- Conditions
- Mobility Limitation
- Keywords
- Aging, Health Services, Knowledge Translation, Long-Term Care Facilities, Mobility, Psychosocial And Health Behaviours
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), CapitalCare Continuing Care, Extendicare, Good Samaritan Society, Shepherd's Care Foundation
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Nov 2011 (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.
Almost 90 percent of residents living in long-term care facilities have some type of mobility limitation, which worsens quickly once they move into a long-term care facility. This means that they cannot easily walk or move around in their day-to-day lives and this can have serious consequences for their general health and well-being. Researchers have shown that exercise can help the mobility of even the oldest of adults but elderly residents in long-term care facilities still commonly sit or lie in bed for long periods of time, in many cases for most of their waking hours. The purpose of this research is to study the effect of a simple physical activity on the mobility and quality of life of residents in long-term care facilities. Researchers will introduce a sit-to-stand activity to health care aides which will become part of their daily routine with residents. The basic sit-to-stand movement is already a part of the daily activities that health care aides do with residents. Specifically, health care aides will ask residents to repeat the sit-to-stand activity at mealtimes, when using the toilet, and on other occasions of daily activity. An important part of this research is to find out how well the activity preserves the ability of residents to stay mobile and also to examine how this will improve their quality of life in the home. The MOVE study will demonstrate whether it is possible to delay the loss of mobility in long-term care residents by incorporating the sit-to-stand activity into the regular practice of health care aides.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sit-to-Stand Activity | Other | Other: Sit-to-Stand Activity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- have a diagnosis of Alzheimer disease, vascular dementia, or mixed dementia
- are able to transfer independently or with the assistance of one person
Key exclusion criteria (2 listed)
- have a diagnosis of fronto-temporal or Lewy-body dementia
- require the assistance of more than one person to transfer, or a transfer lift
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 |
|---|---|---|
| Sit-to-Stand ActivityHealth care aides will be expected to prompt residents to repeatedly stand up and sit down on four occasions throughout the day (twice on each of the day and evening shifts). The number of repetitions on each occasion will vary according to residents' ability and fatigue. The sit-to-stand activity is to be integrated into usual care routines such as when entering the dining room at mealtimes, while toileting, and on other occasions of regular activity. The timing and location will be at the discretion of the health care aide. | Other | Sit-to-Stand Activity |
Primary outcome
Change from Baseline in Mobility at 3 and 6 months
Time frame: Baseline, 3-Months, 6-Months
The sit-to-stand action is a functional activity that has been incorporated into a number of mobility measures. We have chosen to measure mobility using the number of sit-to-stands in 30 seconds because in the frail nursing home population many residents have difficulty transferring (e.g.standing up from a chair). In our pilot study we found many residents were unable to complete more than two or three sit-to-stands. Residents will be instructed to stand up and sit down as many times as possible until they are asked to stop after 30 seconds (Jones, Rikli, \& Beam, 1999).
3 secondary outcomes
Change from Baseline in Function at 3 and 6 months
Time frame: Baseline, 3-Months, 6-Months
Change from Baseline in Health Related Quality of Life at 3 and 6 months
Time frame: Baseline, 3-Months, 6-Months
Change from Baseline in Dementia Specific Quality of Life at 3 and 6 Months
Time frame: Baseline, 3-Months, 6-Months
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 26 Jan 2017.
- Results publication: PubMed 25271194Slaughter SE, Wagg AS, Jones CA, Schopflocher D, Ickert C, Bampton E, Jantz A, Milke D, Schalm C, Lycar C, Estabrooks CA. Mobility of Vulnerable Elders study: effect of the sit-to-stand activity on mobility, function, and quality of life. J Am Med Dir Assoc. 2015 Feb;16(2):138-43. doi: 10.1016/j.jamda.2014.07.020. Epub 2014 Sep 27.
- Derived from this study: PubMed 22176583Slaughter SE, Estabrooks CA, Jones CA, Wagg AS. Mobility of Vulnerable Elders (MOVE): study protocol to evaluate the implementation and outcomes of a mobility intervention in long-term care facilities. BMC Geriatr. 2011 Dec 16;11:84. doi: 10.1186/1471-2318-11-84.
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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.
Susan Slaughter, RN, PhD principal investigator
University of Alberta
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit-to-Stand Activity in people with Mobility Limitation, run by University of Alberta at 4 sites in Canada.
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 2 inclusion and 2 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Change from Baseline in Mobility at 3 and 6 months (time frame: Baseline, 3-Months, 6-Months). 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 NCT01474616, which also lists 2 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 26 Jan 2017.