NCT04044846

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 7, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

August 2, 2019

Last Update Submit

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

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).

Behavioral: Physical activity program for homebound older adults faciliated by Personal Support Workers

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.

Also known as: ProMO
The recipients of the home-based physical activity program

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

FrailtyMobility Limitation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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).
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.

Locations