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

Not Applicable

Not yet recruiting

• Conditions: Frailty

• Registration Number: NCT06894914
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2025-02-23
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-05-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

• Those who do not meet the Inclusion Criteria

Older adults:

Inclusion Criteria:

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.

Exclusion Criteria:

• Those who do not meet the Inclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient's daily time in moderate/vigorous physical activity (minutes/day)	6 months	Minutes spent in moderate/vigorous physical activity per day

Secondary Outcome Measures

Name	Time	Method
Patient's daily time in moderate/vigorous physical activity (minutes/day)	12 months	Minutes spent in moderate/vigorous physical activity per day
Patient's daily time in light physical activity (minutes/day)	12 months	Minutes spent in light physical activity per day
Patient's daily time in sedentary behaviour (minutes/day)	12 months	Minutes spent in sedentary behaviour per day
Patient's daily time sleeping (minutes/day)	12 months	Minutes spent sleeping per day
The score of cardiovascular Health Study (CHS) index (Patient outcome)	6 months	multidimensional measure of physical frailty (0-5 points; lower = better); 1. Weight Loss: Lost \> 10 pounds unintentionally in last year; 2. Exhaustion Self-report of either of: i. felt that everything I did was an effort in the last week ii. could not get going in the last week; 3. Weakness Grip strength: Lowest 20% adjusted for sex and body mass index; 4. Low Physical Activity Women: Kcal \< 270 on activity scale (18 items)§ Men: Kcal \< 383 on activity scale (18 items)§; 5. Slowness Walking time: Slowest 20% adjusted by sex and height; "Yes" to each of the above is 1 point.
The Cardiovascular Health Study (CHS) index score (Patient outcome)	12 months	multidimensional measure of physical frailty (0-5 points; lower = better); 1. Weight Loss: Lost \> 10 pounds unintentionally in last year; 2. Exhaustion Self-report of either of: i. felt that everything I did was an effort in the last week ii. could not get going in the last week; 3. Weakness Grip strength: Lowest 20% adjusted for sex and body mass index; 4. Low Physical Activity Women: Kcal \< 270 on activity scale (18 items)§ Men: Kcal \< 383 on activity scale (18 items)§; 5. Slowness Walking time: Slowest 20% adjusted by sex and height; "Yes" to each of the above is 1 point.
Short Physical Performance Battery (SPPB; 0-12; higher = better; Patient outcome)	12 months	Short Physical Performance Battery (SPPB) is a standardized measure of lower extremity physical performance that includes walking, balance, and strength tasks, and has been used in a broad range of RCTs and epidemiological studies of aging. A low SPPB score is a strong risk factor for institutionalization, morbidity, mortality, and disability in initially non-disabled older persons. Participants are assessed on performances of standing balance, 4-m walking, and sit-to-stand. Each component is rated out of 4 points, for a maximum of 12 points.
Gait speed (meters/second; Patient outcome)	12 months	Gait speed will be calculated by dividing the 4-meter walk with the time to complete the walk
Grip strength (in kg) of the dominant hand (Patient outcome)	12 months	Grip strength (in kg) of the dominant hand will be measured using a digital Jamar isometric hand dynamometer; three measures will be acquired and averaged.
EuroQol-5D-5 Level version (EQ-5D-5L; Patient outcome)	12 months	measure Health-Related Quality of Life. EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels ('1' indicating no problem; '5' indicating major problem).
Self-Reported Habit Index (Patient outcome)	12 months	A multi-item measure rated on a 7-point Likert scale that evaluates characteristics of habitual behavior

Trial Locations

Locations (1)

Arthritis Research Canada; 🇨🇦 Vancouver, British Columbia, Canada