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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05388227
Other study ID # 141
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date March 31, 2023

Study information

Verified date August 2022
Source University of Saskatchewan
Contact Saija A Kontulainen, PhD
Phone (306) 966-1077
Email saija.kontulainen@usask.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This patient-oriented study aims to co-design and pilot a pole walking intervention with residents and staff of the participating independent living/retirement communities. The proposed pilot will answer the following principal question: Is pole walking intervention feasible in the independent living/retirement communities? We will also assess if pole walking intervention will be associated with improved physical activity, function, mobility and quality of life. The final format of the intervention will be designed with resident- and staff-advisors. We anticipate that the pole walking sessions will be held outdoors, 2-3 times a week, for 20-60 min/session, over 12 weeks.


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 of pole walking intervention in older adults living in independent living/retirement communities. This study is a patient-oriented pilot intervention. Our target is to include 50 independent living/retirement community's residents. Pole walking exercises are based on ongoing, patient-oriented Nordic Walking intervention, tailored for participants and progressive in nature. Training sessions will be led by trained peer/staff/student-instructors. Training sessions will be held outdoors, 2-3 times a week, for 20-60 min/session, over 12 weeks.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Being an ambulatory resident in the independent living/retirement - 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>1h/week) - Diagnosed with Parkinson's disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pole Walking
Group training sessions will be offered at the participating independent living/retirement communities. Training sessions will be held either indoors or outdoors, 2-3 times a week, for 20-60 min/session, over 12 weeks.

Locations

Country Name City State
Canada Saija Kontulainen, University of Saskatchewan Saskatoon Saskatchewan

Sponsors (3)

Lead Sponsor Collaborator
University of Saskatchewan Saskatchewan Centre for Patient-Oriented Research, Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse Events We will probe participants for adverse events at each study visit and fill out adverse event forms that provide details on the type of adverse event, severity, frequency, and relationship to the intervention according to the CONSORT guidelines. 2-5 minutes
Other Health We will assess participant health and medications using a questionnaire. 5-15 minutes
Primary Feasibility of pole walking intervention We will assess feasibility by calculating participant consent rate and retention. 5-10 minutes
Primary Protocol fidelity We assess protocol fidelity (attached survey) by participants, peer/student-trainees, and staff after the Pole walking intervention. 3-5 minutes
Secondary Muscle strength Assessed by sit-to-stand test and grip strength. 3-5 minutes
Secondary Gait and functional balance Assessed gait and functional balance by timed up and go test. 3-5 minutes
Secondary Walking test Assessed by 6-minute walking test with and without poles. 5-10 minutes
Secondary Imaged bone and muscle properties Assessed by peripheral quantitative computed tomography (pQCT). 20-30 minutes
Secondary Total body lean and fat tissue mass, bone density at total body, hip and lumbar spine. Assessed by dual-energy X-ray absorptiometry (DXA) 10-20 minutes
Secondary Exercise confidence Assessed by Exercise self-efficacy scale. 3-5 minutes
Secondary Nutrition We will assess dietary intakes using food frequency questionnaire. 20 minutes
Secondary Fear of falling Assessed by the 10-item falls efficacy scale. Scale consists of 10 questions with responses ranging from 1 (not confident at all) to 10 (very confident). Higher values are better outcomes. Sub-scale values are summed and total value is recorded. 2-5 minutes
Secondary Health-related quality of life Assessed by the The Short Form (SF36) Health Survey. 3-5 minutes
Secondary Physical activity We will record physical activity using activity monitors (accelerometers). 7 days
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