Pole Walking Intervention in Retirement Communities

Fall Injury Clinical Trial

Official title:

Pole Walking Intervention Within Independent Living/Retirement Communities: Feasibility and Pilot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05388227
• Other study ID #: 141
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Fall Injury
• Osteoporotic Fractures

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