NCT05388227

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2025

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

May 18, 2022

Last Update Submit

April 27, 2026

Conditions

Keywords

Patient-orientedExercise InterventionFeasibilityPilot

Outcome Measures

Primary Outcomes (10)

  • Feasibility of pole walking intervention - consent rate

    Assessed by calculating consent rate (%) as the percentage of participants assessed for eligibility who consented.

    After the completion of the study's feasibility phase (1 year)

  • Feasibility of pole walking intervention - recruitment rate

    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.

    After the completion of the study's feasibility phase (1 year)

  • Feasibility of pole walking intervention - retention rate

    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

    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

    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

    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.

    Follow-up assessment sessions (after the 12-week intervention of the study's feasibility phase)

  • Feasibility of pole walking intervention - intervention feasibility score

    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

    Assessed by the timed "up \& go" test.

    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

    Assessed by the 30-s chair stand test.

    Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)

  • Health-related quality of life

    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).

    Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)

Secondary Outcomes (7)

  • Safety of pole walking intervention

    Follow-up assessment sessions (after the 12-week intervention of the study's feasibility phase)

  • Physical function - functional capacity

    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

    Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)

  • Physical activity/sedentary time

    Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)

  • Fear of falling

    Baseline and follow-up assessment sessions (before and after the 12-week intervention of the study's feasibility and pilot phases)

  • +2 more secondary outcomes

Other Outcomes (2)

  • Body composition - areal bone mineral density at the hip

    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

    Baseline assessment sessions (before the 12-week intervention of the study's feasibility and pilot phases)

Study Arms (2)

Pole walking intervention

EXPERIMENTAL

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.

Other: Pole walking

Wait-list control

NO INTERVENTION

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.

Interventions

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).

Pole walking intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Using assistive devices for mobility.
  • Being active (moderate-to-vigorous physical activity ≥150 min/week).
  • Diagnosed with Parkinson's disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saija Kontulainen, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 1G9, Canada

Location

MeSH Terms

Conditions

Osteoporotic Fractures

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

WalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Saija A Kontulainen, PhD

    Professor, College of Kinesiology, University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The feasibility phase of this study is a single-group trial with a primary purpose of assessing the feasibility of implementing a pole walking intervention within independent living/retirement communities. The pilot phase of this study is a two-arm, parallel-group, cluster-randomized, wait-list controlled trial with a primary purpose of assessing 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, we anticipate enrolling 50 participants from residents of independent living/retirement communities. Communities will be randomly allocated to either the intervention or a wait-list control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 24, 2022

Study Start

June 28, 2022

Primary Completion

September 22, 2025

Study Completion

September 22, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations