Promoting Movement in Older Adults in the Community

Frailty Clinical Trial

— (ProMO)  

Official title:

Promoting Movement in Older Adults in the Community

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04044846
• Other study ID #: 239-2019
• Status: Withdrawn
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2022
• Source: Regional Geriatric Program of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Mobility Limitation

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.

Locations

Country	Name	City	State
Canada	Regional Geriatric Program of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Regional Geriatric Program of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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