- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06894914
Supporting Uptake of Evidence for Physical Activity in Older Adults With Complex Health Care Needs (Moving_More)
Moving More: Supporting Uptake of Evidence for Physical Activity in Older Adults With Complex Health Care Needs
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Current Approach (focus on achieving 150 min/week of MVPA).
- 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Linda Li, PhD
- Phone Number: 604-207-4020
- Email: lli@arthritisresearch.ca
Study Contact Backup
- Name: Stephenie Therrien, BA
- Phone Number: 604-207-4053
- Email: stherrien@arthritisresearch.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Y 3P2
- Recruiting
- Arthritis Research Canada
-
Contact:
- Stephanie Therrien, BA
- Phone Number: 604-207-4053
- Email: stherrien@arthritisresearch.ca
-
Contact:
- Shireen Divecha
- Phone Number: 604-207-4041
- Email: sdivecha@arthritisresearch.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- participate in online training for the assigned physical activity counselling strategy
- be randomised to one of the counselling groups.
Exclusion Criteria:
- Those who do not meet the Inclusion Criteria
Older adults:
Inclusion Criteria:
- are age > 65 years
- live in the community
- have 1 or 2 of the deficits in the CHS index
- have > 1 chronic conditions
- are able to walk 3 metres with or without an assistive device
- have a Mini-Mental State Examination score > 24/30
- do not have a diagnosed psychiatric condition (e.g., depression)
- understand, speak and read English proficiently
- are willing to have their physiotherapy sessions audio-recorded
- are able to provide written informed consent.
Exclusion Criteria:
- Those who do not meet the Inclusion Criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 |
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. |
|
Active Comparator: 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 |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient's daily time in moderate/vigorous physical activity (minutes/day)
Time Frame: 6 months
|
Minutes spent in moderate/vigorous physical activity per day
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient's daily time in moderate/vigorous physical activity (minutes/day)
Time Frame: 12 months
|
Minutes spent in moderate/vigorous physical activity per day
|
12 months
|
|
Patient's daily time in light physical activity (minutes/day)
Time Frame: 6 months
|
Minutes spent in light physical activity per day
|
6 months
|
|
Patient's daily time in light physical activity (minutes/day)
Time Frame: 12 months
|
Minutes spent in light physical activity per day
|
12 months
|
|
Patient's daily time in sedentary behaviour (minutes/day)
Time Frame: 6 months
|
Minutes spent in sedentary behaviour per day
|
6 months
|
|
Patient's daily time in sedentary behaviour (minutes/day)
Time Frame: 12 months
|
Minutes spent in sedentary behaviour per day
|
12 months
|
|
Patient's daily time sleeping (minutes/day)
Time Frame: 6 months
|
Minutes spent sleeping per day
|
6 months
|
|
Patient's daily time sleeping (minutes/day)
Time Frame: 12 months
|
Minutes spent sleeping per day
|
12 months
|
|
The score of cardiovascular Health Study (CHS) index (Patient outcome)
Time Frame: 6 months
|
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)
Time Frame: 12 months
|
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)
Time Frame: 6 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.
|
6 months
|
|
Short Physical Performance Battery (SPPB; 0-12; higher = better; Patient outcome)
Time Frame: 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.
|
12 months
|
|
Gait speed (meters/second; Patient outcome)
Time Frame: 6 months
|
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)
Time Frame: 12 months
|
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)
Time Frame: 6 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.
|
6 months
|
|
Grip strength (in kg) of the dominant hand (Patient outcome)
Time Frame: 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.
|
12 months
|
|
EuroQol-5D-5 Level version (EQ-5D-5L; Patient outcome)
Time Frame: 6 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).
|
6 months
|
|
EuroQol-5D-5 Level version (EQ-5D-5L; Patient outcome)
Time Frame: 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).
|
12 months
|
|
Self-Reported Habit Index (Patient outcome)
Time Frame: 6 months
|
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)
Time Frame: 12 months
|
A multi-item measure rated on a 7-point Likert scale that evaluates characteristics of habitual behavior
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Linda Li, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H25-03073
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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