Clinical trial NCT06894914: Supporting Uptake of Evidence for Physical Activity in Older Adults With Complex Health Care Needs
Official title: Moving More: Supporting Uptake of Evidence for Physical Activity in Older Adults With Complex Health Care Needs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty
Keywords: Physiotherapy
Physical activity
Sleep
Counselling
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Arthritis Research Centre of Canada
First posted: 2025-03-25
Enrollment: 20
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Physiotherapists:

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

Primary outcomes:
measure: Patient's daily time in moderate/vigorous physical activity (minutes/day)
timeFrame: 6 months
Secondary outcomes:
measure: Patient's daily time in moderate/vigorous physical activity (minutes/day)
timeFrame: 12 months
measure: Patient's daily time in light physical activity (minutes/day)
timeFrame: 6 months
measure: Patient's daily time in light physical activity (minutes/day)
timeFrame: 12 months
measure: Patient's daily time in sedentary behaviour (minutes/day)
timeFrame: 6 months
measure: Patient's daily time in sedentary behaviour (minutes/day)
timeFrame: 12 months
measure: Patient's daily time sleeping (minutes/day)
timeFrame: 6 months
measure: Patient's daily time sleeping (minutes/day)
timeFrame: 12 months
measure: The score of cardiovascular Health Study (CHS) index (Patient outcome)
timeFrame: 6 months
measure: The Cardiovascular Health Study (CHS) index score (Patient outcome)
timeFrame: 12 months
measure: Short Physical Performance Battery (SPPB; 0-12; higher = better; Patient outcome)
timeFrame: 6 months
measure: Short Physical Performance Battery (SPPB; 0-12; higher = better; Patient outcome)
timeFrame: 12 months
measure: Gait speed (meters/second; Patient outcome)
timeFrame: 6 months
measure: Gait speed (meters/second; Patient outcome)
timeFrame: 12 months
measure: Grip strength (in kg) of the dominant hand (Patient outcome)
timeFrame: 6 months
measure: Grip strength (in kg) of the dominant hand (Patient outcome)
timeFrame: 12 months
measure: EuroQol-5D-5 Level version (EQ-5D-5L; Patient outcome)
timeFrame: 6 months
measure: EuroQol-5D-5 Level version (EQ-5D-5L; Patient outcome)
timeFrame: 12 months
measure: Self-Reported Habit Index (Patient outcome)
timeFrame: 6 months
measure: Self-Reported Habit Index (Patient outcome)
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Arthritis Research Canada
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Linda Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: