Study 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.
Promoting Movement in Older Adults in the Community
(ProMO)
1 other identifier
interventional
N/A
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
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Started Oct 2020
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedStudy Start
First participant enrolled
October 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedAugust 5, 2022
August 1, 2022
1.4 years
August 2, 2019
August 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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).
6 months
Study Arms (1)
The recipients of the home-based physical activity program
EXPERIMENTALFrail 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Older adults living with frailty who are homebound and using home care services.
You may not qualify if:
- Older adults who are not living with frailty and not homebound.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Regional Geriatric Program of Toronto
Toronto, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2019
First Posted
August 5, 2019
Study Start
October 7, 2020
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
August 5, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared with other researchers.