- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05388227
Pole Walking Intervention in Retirement Communities
Pole Walking Intervention Within Independent Living/Retirement Communities: Feasibility and Pilot
This patient-oriented, multi-site study aims to co-design and test a pole walking program with resident and staff representatives from participating independent living and retirement communities.
The first part of the study (feasibility phase) is a single-group trial designed to answer the main question: Is the pole walking program feasible in these settings? In this phase, all participants will take part in the program.
The second part of the study (pilot phase) is a two-group randomized trial that will assess whether the program helps improve physical activity, physical function, body composition, fear of falling, and health-related quality of life, while also reducing sedentary time (time spent sitting or being inactive) in older adults living in independent living and retirement communities. Communities will be randomly assigned to either start the program right away or join a wait-list control group.
The program will include supervised group sessions held at the participating communities, 2-3 times per week, for 20-60 minutes each session, over a 12-week period. Sessions will take place outdoors when possible, or indoors if the weather is not suitable.
After follow-up assessments are complete, participants in the control group will also be offered the pole walking program at their communities.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pole walking provides an attractive form of exercise therapy for older adults. It is a simple, well-tolerated, and effective means to improve overall functional fitness in older adults. Pole walking has improved upper and lower body muscle strength, cardiovascular endurance, and flexibility in community-dwelling older adults. It has been positively associated with balance, functional mobility, muscle strength, and aerobic exercise capacity in older adults. Pole walking is considered to offer a safe format for walking, as poles provide support and help with balance, and thus contribute to confidence in being active. However, there has not yet been a study assessing the feasibility and efficacy of a pole walking intervention in improving physical activity, physical function, body composition, fear of falling, and health-related quality of life, and decreasing sedentary time in older adults living in independent living/retirement communities.
This patient-oriented, multi-site study consists of a feasibility and a pilot phase. The feasibility phase is a single-arm trial that will assess the feasibility and safety of implementing a pole walking intervention within independent living/retirement communities. In this phase, all participants will receive the intervention. The pilot phase is a two-arm, parallel-group, cluster-randomized, wait-list controlled trial that will assess the efficacy of the pole walking intervention in improving physical activity, physical function, body composition, fear of falling, and health-related quality of life, and decreasing sedentary time in older adults living in independent living/retirement communities. In this phase, our target is to include 50 residents from independent living/retirement communities. Sites will be randomized to either the intervention or a wait-list control group. The intervention will consist of group sessions held at the participating communities, 2-3 times per week, for 20-60 minutes per session, over a 12-week period. Pole walking exercises are tailored for participants and progressive in nature. Sessions will be led by trained peer, staff, or student instructors and conducted outdoors (indoors if weather conditions do not permit). After completing follow-up assessments, participants in the control group will also be offered the pole walking program at their sites.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 1G9
- Saija Kontulainen, University of Saskatchewan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- Being an ambulatory resident in the independent living/retirement communities.
- Pass the Get Active Questionnaire. If the participant has heart conditions, angina during daily living, balance, and bone or joint problems, then a Physician Clearance Form is required to be filled out and signed by the participant's family physician.
Exclusion Criteria:
- Using assistive devices for mobility.
- Being active (moderate-to-vigorous physical activity ≥150 min/week).
- Diagnosed with Parkinson's disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pole walking intervention
Will participate in supervised, group pole walking intervention sessions held at the participating communities, 2-3 times per week, for 20-60 minutes per session, over a 12-week period.
|
The intervention will consist of group sessions held at the participating communities, 2-3 times per week, for 20-60 minutes per session, over a 12-week period.
Pole walking exercises are tailored for participants and progressive in nature.
Sessions will be led by trained peer, staff, or student instructors and conducted outdoors (indoors if weather conditions do not permit).
|
|
No Intervention: Wait-list control
Will continue life as usual during the 12-week period.
However, after completing follow-up assessments, will also be offered the pole walking intervention at their communities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of pole walking intervention - consent rate
Time Frame: After the completion of the study's feasibility phase (1 year)
|
Assessed by calculating consent rate (%) as the percentage of participants assessed for eligibility who consented.
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After the completion of the study's feasibility phase (1 year)
|
|
Feasibility of pole walking intervention - recruitment rate
Time Frame: After the completion of the study's feasibility phase (1 year)
|
Assessed by calculating recruitment rate (participant/site/month) as the number of potentially eligible participants who consented divided by the number of recruiting sites and then divided by the number of months spent on recruitment.
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After the completion of the study's feasibility phase (1 year)
|
|
Feasibility of pole walking intervention - retention rate
Time Frame: After the completion of the study's feasibility phase (1 year)
|
Assessed by calculating retention rate (%) as the percentage of eligible participants enrolled in the study who received the allocated intervention and completed both baseline and follow-up assessments.
|
After the completion of the study's feasibility phase (1 year)
|
|
Feasibility of pole walking intervention - attendance rate
Time Frame: After the completion of the study's feasibility phase (1 year)
|
Assessed by calculating attendance rate (%) as the percentage of available intervention sessions attended by each participant.
|
After the completion of the study's feasibility phase (1 year)
|
|
Feasibility of pole walking intervention - intervention acceptability score
Time Frame: Follow-up assessment sessions (after the 12-week intervention of the study's feasibility phase)
|
Assessed by calculating intervention acceptability score (ranging from 1-5, with higher scores indicating greater acceptability of an intervention ) using the 4-item intervention acceptability measure.
|
Follow-up assessment sessions (after the 12-week intervention of the study's feasibility phase)
|
|
Feasibility of pole walking intervention - intervention appropriateness score
Time Frame: Follow-up assessment sessions (after the 12-week intervention of the study's feasibility phase)
|
Assessed by calculating intervention appropriateness score (ranging from 1-5, with higher scores indicating greater appropriateness of an intervention ) using the 4-item intervention appropriateness measure.
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Follow-up assessment sessions (after the 12-week intervention of the study's feasibility phase)
|
|
Feasibility of pole walking intervention - intervention feasibility score
Time Frame: Follow-up assessment sessions (after the 12-week intervention of the study's feasibility phase)
|
Assessed by calculating intervention feasibility score (ranging from 1-5, with higher scores indicating greater feasibility of an intervention ) using the 4-item intervention feasibility measure.
|
Follow-up assessment sessions (after the 12-week intervention of the study's feasibility phase)
|
|
Physical function - functional balance/mobility
Time Frame: Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
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Assessed by the timed "up & go" test.
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Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
|
Physical function - lower-body strength
Time Frame: Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
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Assessed by the 30-s chair stand test.
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Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
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Health-related quality of life
Time Frame: Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
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Assessed by the 36-item short form survey, which provides a score ranging from 0-100 for each of its 8 scales (the higher the scale scores, the more favorable the corresponding health states).
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Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety of pole walking intervention
Time Frame: Follow-up assessment sessions (after the 12-week intervention of the study's feasibility phase)
|
Assessed by the seriousness and relatedness to the intervention of recorded adverse events.
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Follow-up assessment sessions (after the 12-week intervention of the study's feasibility phase)
|
|
Physical function - functional capacity
Time Frame: Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
Assessed by the 6-min walk test.
|
Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
|
Physical function - upper-body strength
Time Frame: Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
Assessed by the grip strength test.
|
Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
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Physical activity/sedentary time
Time Frame: Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
Assessed by 7-day accelerometry.
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Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
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Fear of falling
Time Frame: Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
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Assessed by the 10-item falls efficacy scale, which provides a total score ranging from 10-100, with higher scores suggesting greater fear of falling.
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Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
|
Body composition - musculoskeletal properties of the lower leg
Time Frame: Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
Assessed by the peripheral quantitative computed tomography.
|
Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
|
Body composition - musculoskeletal properties of the forearm
Time Frame: Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
Assessed by the peripheral quantitative computed tomography.
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Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition - areal bone mineral density at the hip
Time Frame: Baseline assessment sessions (before the 12-week intervention of the study's feasibility and pilot phases)
|
Assessed by the dual-energy X-ray absorptiometry.
|
Baseline assessment sessions (before the 12-week intervention of the study's feasibility and pilot phases)
|
|
Body composition - areal bone mineral density at the lumbar spine
Time Frame: Baseline assessment sessions (before the 12-week intervention of the study's feasibility and pilot phases)
|
Assessed by the dual-energy X-ray absorptiometry.
|
Baseline assessment sessions (before the 12-week intervention of the study's feasibility and pilot phases)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Saija A Kontulainen, PhD, Professor, College of Kinesiology, University of Saskatchewan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 141
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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