Promoting Movement in Older Adults in the Community ((ProMO))

August 2, 2022 updated by: Regional Geriatric Program of Toronto
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Regional Geriatric Program of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: Physical activity program for homebound older adults faciliated by Personal Support Workers
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:
  • ProMO

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regional Geriatric Program of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 239-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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