Frailty(ProMO)NCT04044846
Promoting Movement in Older Adults in the Community
A study testing Physical activity program for homebound older adults faciliated by Personal Support Workers in people with Frailty and Mobility Limitation, run by Regional Geriatric Program of Toronto at 1 site in Canada.
Trial summary
It is well known that exercise is great medicine, however, for frail older adults who are often homebound and require assistance with personal care, there are gaps in both prescribing this "medicine" and in filling the prescription. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Frailty, Mobility Limitation
- What is being tested?
- Physical activity program for homebound older adults faciliated by Personal Support Workers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 7 Oct 2020to 28 Feb 2022
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older adults living with frailty who are homebound and using home care services.
Who cannot join
- Older adults who are not living with frailty and not homebound.
Trial locations and contacts
1 site in 1 country.
About this study
It is well known that exercise is great medicine, however, for frail older adults who are often homebound and require assistance with personal care, there are gaps in both prescribing this "medicine" and in filling the prescription. The investigators will uncover and address the barriers that prevent frail older adults from increasing their level of physical activity. With input from frail older adults, caregivers, and healthcare providers, the investigators will create a free, easy to use, home-based program that incorporates physical activity such as gentle stretches and range of motion exercises when personal care is being provided. This innovation will add great value to the type of care that is being provided to homebound frail older adults. Incorporating physical activity as part of the care provided offers a unique opportunity for homebound frail older adults to move more, and improve their well-being.
Read the detailed description
Mobilization in frail older adults (OAs) can improve cardiovascular outcomes, musculoskeletal function, and functional independence (Bray, Smart, Jakobi, \& Jones, 2016) (Roland, Theou, Jakobi, \& Frailty, 2014) (Theou et al., 2011). Detriments of immobility include an increased risk of functional disability, falls, and premature mortality (Hubbard, Parsons, Neilson, \& Carey, 2009). There are numerous mobility interventions targeted to community-dwelling frail OAs (Sherrington et al., 2019); however, they either have a narrow focus on falls prevention (Fairhall, Sherrington, \& Cameron, 2013) (Sherrington et al., 2019) or they target mildly frail OAs (Johnson, Myers, Scholey, Cyarto, \& Ecclestone, 2003) (Giangregorio et al., 2018) (Binder et al., 2002). A review of home-based mobility interventions concluded that high-risk OAs who have been recently discharged from hospital may require an intervention that is tailored specifically for them (Hill, Hunter, Batchelor, Cavalheri, \& Burton, 2015) (Sherrington et al., 2019). The intervention will focus on active range of motion exercises in frail OAs who are homebound or recovering from a health crisis and unable to participate in more rigorous exercise regimens. Gentle stretches and range of motion activities can have immediate benefits to frail OAs. (O'Brien Cousins \& Horne, 1999).
The first objective is to create an evidence- informed, theory-driven mobility intervention for community-dwelling OAs who are moderately and severely frail according to the clinical frailty scale (Rockwood et al., 2005). The intervention, entitled Promoting Movement in OAs (ProMO), will be implementable with frail OAs in partnership with any care provider in the home such as personal support workers (PSWs) and families. The investigators will focus the study on the two main providers of care- PSWs. OAs, PSWs, and caregivers will co-create ProMO with us. ProMO will be distinct from existing home-based exercise programs (Johnson et al., 2003) (Giangregorio et al., 2018) because it will optimize natural opportunities for mobilization during care (e.g., bathing and dressing) and will be embedded in facilitated activities of daily living. The second objective is to pilot and evaluate ProMO in the Greater Toronto Area (GTA). The primary output will be a free, user-friendly, and sustainable mobility intervention. A secondary output will be new knowledge about the process and outcome of a tailored, home-based mobility intervention.
- Conditions
- Frailty, Mobility Limitation
- Being tested
- Physical activity program for homebound older adults faciliated by Personal Support Workers
- Medical subject headings
- Frailty, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity program for homebound older adults faciliated by Personal Support WorkersBehavioural
Also called ProMO
The intervention is an evidence- informed, theory-driven mobility intervention for community-dwelling OAs who are moderately and severely frail according to the clinical frailty scale (Rockwood et al., 2005). The intervention, entitled Promoting Movement in OAs (ProMO), will be implementable with frail OAs in partnership with any care provider in the home. Investigators will focus the study on the two main providers of care- personal support workers (PSWs) and family caregivers. OAs, PSWs, and caregivers will co-create ProMO with us. ProMO will be distinct from existing home-based exercise programs (Johnson et al., 2003) (Giangregorio et al., 2018) because it will optimize natural opportunities for mobilization during care (e.g., bathing and dressing) and will be embedded in facilitated activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| The recipients of the home-based physical activity program | Experimental | Frail OAs will be asked to fill out the Vitality Plus Scale at the beginning of the implementation phase (baseline) by a research assistant over the telephone. At the end of the 6-month implementation phase, the research assistant will administer the survey again (post-intervention). Receives: Behavioral: Physical activity program for homebound older adults faciliated by Personal Support Workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived benefit of exercise
The 10-item Vitality Plus Scale (VPS) was developed to measure the health-related benefits of mobilization specifically in OAs. It is a self-administered, 10-item scale, which assesses multiple domains, including sleep, energy, pain and mood. Participants will be asked to provide a rating from 1 to 5 for each of the 10 items. A total score will be calculated for each individual and a total score can range from 1 to 50. A 10% increase in VPS score was considered clinically significant for an individual. The investigators hypothesize that the intervention will result in an increase in post VPS scores. The VPS has been shown to be reliable and valid, sensitive to change and easy for OAs to use. It has been used to measure the effects of mobilization in randomized controlled trials (Li et al., 2013) (Burton, Lewin, Clemson \& Boldy, 2013) (Chin A Paw, van Poppel, Twisk \& van Mechelen, 2004) (Stiggelbout, 2004).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start7 Oct 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Why it stopped: The COVID-19 pandemic caused several challenges with recruitment in the home care sector. It was not possible to proceed with the study as originally intended in this clinical trial record.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The pilot evaluation will have a quasi-experimental pre-test/post-test design and investigators will collect self- reported data from frail older adults on the perceived benefit of exercise using the Vitality Plus Scale (VPS) (Myers et al., 1999).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Geriatric Program of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044846
- Sponsor's protocol ID
- 239-2019
- Acronym
- (ProMO)
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2019
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Movement in Older Adults in the Community
- ClinicalTrials.gov ID
- NCT04044846
- Acronym / sponsor ID
- (ProMO) / 239-2019
- Conditions
- Frailty, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The COVID-19 pandemic caused several challenges with recruitment in the home care sector. It was not possible to proceed with the study as originally intended in this clinical trial record.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regional Geriatric Program of TorontoUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 5 Aug 2019 (actual)
- 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.
It is well known that exercise is great medicine, however, for frail older adults who are often homebound and require assistance with personal care, there are gaps in both prescribing this "medicine" and in filling the prescription. The investigators will uncover and address the barriers that prevent frail older adults from increasing their level of physical activity. With input from frail older adults, caregivers, and healthcare providers, the investigators will create a free, easy to use, home-based program that incorporates physical activity such as gentle stretches and range of motion exercises when personal care is being provided. This innovation will add great value to the type of care that is being provided to homebound frail older adults. Incorporating physical activity as part of the care provided offers a unique opportunity for homebound frail older adults to move more, and improve their well-being.
Detailed description
Mobilization in frail older adults (OAs) can improve cardiovascular outcomes, musculoskeletal function, and functional independence (Bray, Smart, Jakobi, \& Jones, 2016) (Roland, Theou, Jakobi, \& Frailty, 2014) (Theou et al., 2011). Detriments of immobility include an increased risk of functional disability, falls, and premature mortality (Hubbard, Parsons, Neilson, \& Carey, 2009). There are numerous mobility interventions targeted to community-dwelling frail OAs (Sherrington et al., 2019); however, they either have a narrow focus on falls prevention (Fairhall, Sherrington, \& Cameron, 2013) (Sherrington et al., 2019) or they target mildly frail OAs (Johnson, Myers, Scholey, Cyarto, \& Ecclestone, 2003) (Giangregorio et al., 2018) (Binder et al., 2002). A review of home-based mobility interventions concluded that high-risk OAs who have been recently discharged from hospital may require an intervention that is tailored specifically for them (Hill, Hunter, Batchelor, Cavalheri, \& Burton, 2015) (Sherrington et al., 2019). The intervention will focus on active range of motion exercises in frail OAs who are homebound or recovering from a health crisis and unable to participate in more rigorous exercise regimens. Gentle stretches and range of motion activities can have immediate benefits to frail OAs. (O'Brien Cousins \& Horne, 1999).
The first objective is to create an evidence- informed, theory-driven mobility intervention for community-dwelling OAs who are moderately and severely frail according to the clinical frailty scale (Rockwood et al., 2005). The intervention, entitled Promoting Movement in OAs (ProMO), will be implementable with frail OAs in partnership with any care provider in the home such as personal support workers (PSWs) and families. The investigators will focus the study on the two main providers of care- PSWs. OAs, PSWs, and caregivers will co-create ProMO with us. ProMO will be distinct from existing home-based exercise programs (Johnson et al., 2003) (Giangregorio et al., 2018) because it will optimize natural opportunities for mobilization during care (e.g., bathing and dressing) and will be embedded in facilitated activities of daily living. The second objective is to pilot and evaluate ProMO in the Greater Toronto Area (GTA). The primary output will be a free, user-friendly, and sustainable mobility intervention. A secondary output will be new knowledge about the process and outcome of a tailored, home-based mobility intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The pilot evaluation will have a quasi-experimental pre-test/post-test design and investigators will collect self- reported data from frail older adults on the perceived benefit of exercise using the Vitality Plus Scale (VPS) (Myers et al., 1999).
| Arm | Type | Receives |
|---|---|---|
| The recipients of the home-based physical activity program | Experimental | Behavioral: Physical activity program for homebound older adults faciliated by Personal Support WorkersFrail OAs will be asked to fill out the Vitality Plus Scale at the beginning of the implementation phase (baseline) by a research assistant over the telephone. At the end of the 6-month implementation phase, the research assistant will administer the survey again (post-intervention). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older adults living with frailty who are homebound and using home care services.
Key exclusion criteria (1 listed)
- Older adults who are not living with frailty and not homebound.
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 |
|---|---|---|
| Physical activity program for homebound older adults faciliated by Personal Support WorkersAlso: ProMOThe intervention is an evidence- informed, theory-driven mobility intervention for community-dwelling OAs who are moderately and severely frail according to the clinical frailty scale (Rockwood et al., 2005). The intervention, entitled Promoting Movement in OAs (ProMO), will be implementable with frail OAs in partnership with any care provider in the home. Investigators will focus the study on the two main providers of care- personal support workers (PSWs) and family caregivers. OAs, PSWs, and caregivers will co-create ProMO with us. ProMO will be distinct from existing home-based exercise programs (Johnson et al., 2003) (Giangregorio et al., 2018) because it will optimize natural opportunities for mobilization during care (e.g., bathing and dressing) and will be embedded in facilitated activities of daily living. | Behavioural | The recipients of the home-based physical activity program |
Primary outcome
Perceived benefit of exercise
Time frame: 6 months
The 10-item Vitality Plus Scale (VPS) was developed to measure the health-related benefits of mobilization specifically in OAs. It is a self-administered, 10-item scale, which assesses multiple domains, including sleep, energy, pain and mood. Participants will be asked to provide a rating from 1 to 5 for each of the 10 items. A total score will be calculated for each individual and a total score can range from 1 to 50. A 10% increase in VPS score was considered clinically significant for an individual. The investigators hypothesize that the intervention will result in an increase in post VPS scores. The VPS has been shown to be reliable and valid, sensitive to change and easy for OAs to use. It has been used to measure the effects of mobilization in randomized controlled trials (Li et al., 2013) (Burton, Lewin, Clemson \& Boldy, 2013) (Chin A Paw, van Poppel, Twisk \& van Mechelen, 2004) (Stiggelbout, 2004).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program for homebound older adults faciliated by Personal Support Workers in people with Frailty and Mobility Limitation, run by Regional Geriatric Program of Toronto at 1 site 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 5 Aug 2022. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Perceived benefit of exercise (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2022.