Supporting Uptake of Evidence for Physical Activity in Older Adults With Complex Health Care Needs

NCT ID: NCT06894914

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-12-30

Brief Summary

Physically frail older adults often have chronic conditions that contribute to a higher chance of them being limited in daily activities and becoming dependent. Physical activity can help to better manage chronic conditions and prevent frailty. In this project, the counselling approach using the new Canadian 24-hour Movement Guidelines will be adapted for older adults at an early state of frailty. This new approach will be tested against the one in current use by physiotherapists. This ethics application will address the pilot implementation evaluation, including interviews and focus groups, conducted to refine the new approach.

Detailed Description

Rationale:

Physical activity is effective in preventing the progression of frailty and further disability in community-dwelling frail older adults. It is also effective in mitigating the progression of chronic conditions associated with physical frailty. Despite the benefits, many older adults in the early state of frailty and with chronic conditions are not sufficiently active. Current delivery of physical activity recommendations can be improved by applying the new Canadian 24-hour Movement Guidelines. These guidelines promote a balance of activity, rest and sleep as they play an important role for better overall health and quality of life regardless of health conditions. With advanced training in complex chronic conditions and physical activity promotion, physiotherapists (PTs) are well-suited to adapt and integrate activity counselling, based on the 24-hour Movement Guidelines, in their clinical practice.

Aim:

to assess implementation context, feasibility, and preliminary effect of the 24-hour Approach against a current goal-oriented counselling approach (i.e., focus on achieving 150 minutes/week of MVPA).

Previous Work:

A PT-led goal-oriented counselling program was previously evaluated for older adults with osteoarthritis. In 2 randomized controlled trials (RCTs), compared to controls, this program was shown to improve time spent in Moderate/Vigorous Physical Activity (MVPA) in participants after 8 weeks (n=61; 25.6 mins/day; 95% CI. 9) and 13 weeks (n=51; 13.1 mins/day; 95% CI. 5). This current approach has been modified for remote delivery during the COVID-19 pandemic.

Research Design & Data Analysis:

This is a multi-method study. PTs and their patients across Canada who have participated in the co-development of the 24-hour Approach will be invited to participate. The 24-hour Approach will be assessed in a randomized pilot study with 20 PTs and their patients (each PT will treat 4 older adult patients) who will be assigned to one of the groups:

1. Current Approach (focus on achieving 150 min/week of MVPA).

2. 24-hour Approach (focus on increasing MVPA with a balance of activity, rest and sleep in a day).

Guided by the RE-AIM framework, Reach will be assessed by comparing characteristics of older adult participants with those who are eligible yet decline to participate. Effect (Preliminary) will be evaluated at the older adult level. Adoption will be assessed by comparing the demographic and practice characteristics between the participating PTs and those who are eligible but have not enrolled. Implementation will be assessed by PT interviews when they complete their sessions with all 4 older adult patients. To assess Maintenance, PTs will be interviewed at 12 months about if/how they continue using their assigned counselling strategy after the study. Results will inform a full RCT and future scale-up.

Significance:

Results will provide necessary knowledge to inform how to improve uptake of physical activity recommendations in ways that are sensitive to the health needs of older adults and their life context.

Conditions

Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

24-hour Activity Counselling

Participating physiotherapists will be trained to deliver counselling that focuses on increasing moderate-to-vigorous physical activity, with a balance of activity, rest and sleep in a 24-hour day.

Patients (n=4) of these physiotherapists will receive the 24-hour Activitiy Counselling

Group Type: EXPERIMENTAL

24-hour Activity Counselling

Intervention Type: BEHAVIORAL

Physiotherapists will participate in the self-paced brief action planning (BAP) online training (2-4 hours long), followed by 2-3 hours of practice and feedback over the phone with an experienced BAP instructor. In addition, they will attend a 2-hour session with the research team on training around on prescribing physical activity while balancing with rest and sleep.

Once training is complete the PT can start implementing the counselling approach with the older adult patients.

Current Physical Activity Counselling

Participating physiotherapists will continue delivering counselling that focuses on achieving 150 minutes/week of moderate-to-vigorous physical activity, which is the current practice.

Patients (n=4) of these physiotherapists will receive the Current Physical Activitiy Counselling

Group Type: ACTIVE_COMPARATOR

24-hour Activity Counselling

Intervention Type: BEHAVIORAL

Physiotherapists will participate in the self-paced brief action planning (BAP) online training (2-4 hours long), followed by 2-3 hours of practice and feedback over the phone with an experienced BAP instructor. In addition, they will attend a 2-hour session with the research team on training around on prescribing physical activity while balancing with rest and sleep.

Once training is complete the PT can start implementing the counselling approach with the older adult patients.

Interventions

24-hour Activity Counselling

Physiotherapists will participate in the self-paced brief action planning (BAP) online training (2-4 hours long), followed by 2-3 hours of practice and feedback over the phone with an experienced BAP instructor. In addition, they will attend a 2-hour session with the research team on training around on prescribing physical activity while balancing with rest and sleep.

Once training is complete the PT can start implementing the counselling approach with the older adult patients.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Eligible PTs are those who self-report at least 40% of their caseload is working with older adults and practice in the in the Greater Vancouver Area. In addition, they are willing to:

1. participate in online training for the assigned physical activity counselling strategy

2. be randomised to one of the counselling groups.

Older adults:

1. are age > 65 years

2. live in the community

3. have 1 or 2 of the deficits in the CHS index

4. have > 1 chronic conditions

5. are able to walk 3 metres with or without an assistive device

6. have a Mini-Mental State Examination score > 24/30

7. do not have a diagnosed psychiatric condition (e.g., depression)

8. understand, speak and read English proficiently

9. are willing to have their physiotherapy sessions audio-recorded

10. are able to provide written informed consent.

• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Arthritis Research Centre of Canada

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Linda Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda Li, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Arthritis Research Canada

Vancouver, British Columbia, Canada

Countries

Canada

Central Contacts

Linda Li, PhD

Role: CONTACT

lli@arthritisresearch.ca

604-207-4020

Stephenie Therrien, BA

Role: CONTACT

stherrien@arthritisresearch.ca

604-207-4053

Facility Contacts

Stephanie Therrien, BA

Role: primary

stherrien@arthritisresearch.ca

604-207-4053

Shireen Divecha

Role: backup

sdivecha@arthritisresearch.ca

604-207-4041

Other Identifiers

H24-03597

Identifier Type: -

Identifier Source: org_study_id