- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04044846
Promoting Movement in Older Adults in the Community ((ProMO))
Study Overview
Status
Conditions
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Regional Geriatric Program of Toronto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Older adults living with frailty who are homebound and using home care services.
Exclusion Criteria:
- Older adults who are not living with frailty and not homebound.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The recipients of the home-based physical activity program
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).
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 239-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Frailty
-
University of PennsylvaniaCompleted
-
Instituto Tecnologico y de Estudios Superiores...Not yet recruiting
-
Longeveron Inc.CompletedAging FrailtyUnited States
-
Longeveron Inc.CompletedAging FrailtyUnited States
-
The Hong Kong Polytechnic UniversityCompleted
-
Xijing HospitalUnknownFrailty SyndromeChina
-
Region ZealandUniversity of Southern DenmarkActive, not recruitingFrailty SyndromeDenmark
-
IRCCS Centro San Giovanni di Dio FatebenefratelliCompleted
-
University of Erlangen-Nürnberg Medical SchoolCompleted
-
University of ValenciaCompletedFrailty SyndromeSpain