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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Arthritis Research Centre of Canada | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24-hour Activity Counselling | Experimental | 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 |
|
| Current Physical Activity Counselling | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24-hour Activity Counselling | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's daily time in moderate/vigorous physical activity (minutes/day) | Minutes spent in moderate/vigorous physical activity per day | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's daily time in moderate/vigorous physical activity (minutes/day) | Minutes spent in moderate/vigorous physical activity per day | 12 months |
| Patient's daily time in light physical activity (minutes/day) |
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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:
Exclusion Criteria:
Older adults:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Li, PhD | Contact | 604-207-4020 | lli@arthritisresearch.ca | |
| Stephenie Therrien, BA | Contact | 604-207-4053 | stherrien@arthritisresearch.ca |
| Name | Affiliation | Role |
|---|---|---|
| Linda Li, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis Research Canada | Recruiting | Vancouver | British Columbia | V5Y 3P2 | Canada |
The investigators plan to share individual participant data from this clinical trial, including demographics, baseline characteristics, primary outcome measures, and key secondary outcomes, with qualified researchers upon request after the study results have been published.
TBA
Data will be provided in a de-identified format through a secure online repository, and access will require submission of a research proposal outlining the intended analysis and relevant ethics approvals.
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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|
Minutes spent in light physical activity per day
| 6 months |
| Patient's daily time in light physical activity (minutes/day) | Minutes spent in light physical activity per day | 12 months |
| Patient's daily time in sedentary behaviour (minutes/day) | Minutes spent in sedentary behaviour per day | 6 months |
| Patient's daily time in sedentary behaviour (minutes/day) | Minutes spent in sedentary behaviour per day | 12 months |
| Patient's daily time sleeping (minutes/day) | Minutes spent sleeping per day | 6 months |
| Patient's daily time sleeping (minutes/day) | Minutes spent sleeping per day | 12 months |
| The score of cardiovascular Health Study (CHS) index (Patient outcome) | multidimensional measure of physical frailty (0-5 points; lower = better)
"Yes" to each of the above is 1 point. | 6 months |
| The Cardiovascular Health Study (CHS) index score (Patient outcome) | multidimensional measure of physical frailty (0-5 points; lower = better)
"Yes" to each of the above is 1 point. | 12 months |
| Short Physical Performance Battery (SPPB; 0-12; higher = better; Patient outcome) | 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. | 6 months |
| Short Physical Performance Battery (SPPB; 0-12; higher = better; Patient outcome) | 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. | 12 months |
| Gait speed (meters/second; Patient outcome) | Gait speed will be calculated by dividing the 4-meter walk with the time to complete the walk | 6 months |
| Gait speed (meters/second; Patient outcome) | Gait speed will be calculated by dividing the 4-meter walk with the time to complete the walk | 12 months |
| Grip strength (in kg) of the dominant hand (Patient outcome) | 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. | 6 months |
| Grip strength (in kg) of the dominant hand (Patient outcome) | 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. | 12 months |
| EuroQol-5D-5 Level version (EQ-5D-5L; Patient outcome) | 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). | 6 months |
| EuroQol-5D-5 Level version (EQ-5D-5L; Patient outcome) | 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). | 12 months |
| Self-Reported Habit Index (Patient outcome) | A multi-item measure rated on a 7-point Likert scale that evaluates characteristics of habitual behavior | 6 months |
| Self-Reported Habit Index (Patient outcome) | A multi-item measure rated on a 7-point Likert scale that evaluates characteristics of habitual behavior | 12 months |