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Nordic Walking to Manage Falls and Fear of Falling

Sponsor
Queen's University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05965011
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
16.1
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking (NW) activity program for community-dwelling older adults who are at risk of falling or experience fear of falling (FOF). The study also aims to determine the distribution and effect sizes of outcomes to inform future sample size calculations and explore participants' perspectives of the intervention.

Participants will be asked to:

  • Attend training sessions to learn proper Nordic Walking techniques.

  • Engage in supervised Nordic Walking sessions for a specified duration and frequency.

  • Keep a log of their walking activities and any falls or near falls experienced.

  • Complete questionnaires to assess their fear of falling and overall physical activity levels.

If there is a comparison group:

Researchers will compare the intervention group, consisting of older adults participating in the Nordic Walking program, with a control group of older adults who do not receive the intervention. The comparison will be made to determine if Nordic Walking has a significant impact on reducing falls and fear of falling compared to the control group.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise training
 N/A

Detailed Description

Introduction:

this is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking (NW) activity program for community-dwelling older adults who are at risk of falling or experience fear of falling (FOF). The study also aims to determine the distribution and effect sizes of outcomes to inform future sample size calculations and explore participants' perspectives of the intervention.

Background:

Falls and fear of falling are significant concerns among older adults, leading to physical impairments, psychological trauma, and a decline in abilities and quality of life. Exercise has been shown to be effective in improving muscle strength, balance, mobility, and postural control, all of which are risk factors for falls and FOF. However, traditional exercise programs have limitations in terms of cost, sustainability, and long-term adherence. Nordic Walking, a low-risk and low-tech intervention, has emerged as a promising alternative, offering numerous physical and mental health benefits.

Study Design:

The study will be conducted in two stages. Stage One will involve a two-arm, parallel, single-blind, randomized controlled pilot trial. Forty older adults at risk of falling will be recruited and randomly assigned to either a 10-week NW intervention group or a control group. The intervention group will receive supervised NW training sessions and will be coached to practice independently. The control group will receive regular phone calls to discuss healthy lifestyle habits.

Outcome Measures:

The study will collect feasibility and safety data, including recruitment, adherence, and follow-up rates, as well as adverse events. Effectiveness outcomes will be assessed using measures such as the Timed Up and Go (TUG) test, Stay Independent Falls Risk Assessment Tool, Falls Efficacy Scale-International (FES-I), Activities-Specific Balance Confidence Scale, and the Four-Square Step Test (FSST).

Data Analysis:

Descriptive statistics will be used to characterize participants and feasibility measures. Hedge's effect size and confidence intervals will be calculated. Independent samples t-tests and chi-square tests will be used to compare the intervention and control groups. The main focus of the analysis will be to estimate the effect size, test the intervention's feasibility and safety, and inform future studies.

Sample Size:

The study aims to recruit 40 participants (20 per group) to ensure study robustness and account for potential dropouts.

Stage Two:

In the second stage, qualitative interviews will be conducted with all participants in the intervention group to gather feedback on the acceptability, perceived value, barriers, and facilitators of participating. The data will be analyzed using interpretive description to identify themes and categories.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study will be a pilot trial conducted as a two-arm, parallel, single-blind, randomized controlled trial.This study will be a pilot trial conducted as a two-arm, parallel, single-blind, randomized controlled trial.
Masking:
Single (Outcomes Assessor)
Masking Description:
The single-blind design will involve that the assessors are unaware of the group assignments.
Primary Purpose:
Prevention
Official Title:
Walking on 'Four Legs' to Manage Falls and Fear of Falling
Actual Study Start Date :
Aug 29, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention (Nordic walking)

Nordic walking training. These coaching principles will focus on highlighting the participants' strengths and resourcefulness, setting goals, and utilizing solution-focused problem-solving techniques to achieve those goals during practice and related activities . This group sessions will be conducted biweekly to ensure appropriate progression and adherence to the guidelines set by the International Nordic Walking Federation. In addition to the supervised group sessions, participants will also receive supervised NW training from a certified NW instructor. Participants will be encouraged to set goals and develop strategies to facilitate independent practice for at least three 30-minute sessions per week over a period of 10 weeks. These unsupervised sessions aim to encourage participants to engage in regular practice outside of the group sessions.

Other: Exercise training
The intervention will be a combination of both supervised and unsupervised sessions. Participants in the Nordic Walking (NW) treatment group will attend 5 one-hour group sessions, which will incorporate coaching principles.
Other Names:
  • Nordic walking

    		•
    No Intervention: Control (phone calls)

    The control group will receive regular contact to control for attention and maintain participant engagement throughout the study. Over the course of the 10 weeks, participants in this group will receive 5 biweekly phone calls from the study's graduate research assistant (RA). During each phone call, the RA will engage in discussions with participants about leading a healthy lifestyle in general, covering topics such as proper nutrition and adequate sleep. Additionally, the RA will gather safety-related data, including information on any falls that may have occurred. The phone calls will also serve as reminders for participants about upcoming assessments and their importance in the study. The investigators will provide a training session to the control group following the completion of the study if they are interested.

    Outcome Measures

    Primary Outcome Measures

    1. Estimate the effect size of intervention (Cohen's D) [Through study completion, an average of 1.5 years]

      Effect size estimation is vital in assessing the impact of interventions like Nordic walking and planning future studies. It involves quantifying the magnitude of the intervention's effect on the outcome variable.

    2. Evaluate the adherence rate to the intervention (as a measure of feasibility) [Through study completion, an average of 1.5 years]

      Participant Adherence to the Intervention: This measure examines the extent to which participants adhere to the prescribed Nordic walking program. It involves tracking the frequency, duration, and intensity of Nordic walking sessions completed by participants. Adherence rates can be calculated based on the number of sessions attended or completed as planned.

    3. Assess safety of the intervention [Through study completion, an average of 1.5 years]

      Monitoring Adverse Events: We systematically record and monitor any adverse events or incidents during the study. This includes injuries, discomfort, or any negative effects reported by participants.

    Secondary Outcome Measures

    1. Timed Up and Go (TUG) to assess fall risk [Pre (week 0) /post intervention (week 11)]

      The Timed Up and Go (TUG) test is a widely used clinical assessment tool to evaluate mobility and functional mobility, specifically in older adults. While it is not specifically designed to determine the risk of falling, it can provide valuable information that is correlated with fall risk. The TUG test measures the time it takes for an individual to stand up from a chair, walk a set distance (typically 3 meters), turn around, return to the chair, and sit down again.

    2. Fear of Falling: Fear of falling will be measured by the Falls Efficacy Scale-International (FES-I) [Pre (week 0) /post intervention (week 11)]

      Scale: Falls Efficacy Scale-International (FES-I) Minimum Value: 0 (not at all confident) Maximum Value: 100 (completely confident) Interpretation: In the FES-I, higher scores indicate greater fear of falling. Therefore, a higher score on the FES-I reflects a worse outcome, indicating a higher level of fear and reduced confidence in performing daily activities without falling. Conversely, a lower score on the FES-I suggests a better outcome, indicating a lower level of fear and greater confidence in performing activities without fear of falling.

    3. Performance on the Four-Square Step Test (FSST) will be measured to assess balance. [Pre (week 0) /post intervention (week 11)]

      The Four-Square Step Test (FSST) does not yield a specific score on a scale like some other assessments. Instead, the FSST primarily focuses on the time taken to complete the test and the occurrence of errors or missteps. When assessing FSST performance, the following information is typically recorded: Completion Time: The time the individual takes to complete the FSST is measured in seconds. A shorter completion time generally indicates better balance and agility. Errors or Missteps: The number of errors or missteps made by the individual during the FSST is recorded. Errors can include stepping outside the designated squares, incorrect foot placement, or loss of balance. Fewer errors suggest better balance control and coordination.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Must be 60+ years old.

    • Be at risk of falling, as determined by the Stay Independent Falls Risk Assessment Tool. This validated tool is recommended by the STEADI fall prevention program to evaluate risk of falling.

    Exclusion Criteria:

    • Inability to use walking poles due to medical conditions.

    • Inability to walk 400m independently.

    • Having a medical condition such as unstable cardiorespiratory status, impending angioplasty, or ataxia/dyskinesia (unsteady, staggering gait) that prevents them from participating in physical activities or using walking poles is prohibited.

    • Taking part in any other structured exercise program.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 School of Rehabilitation Therapy, Queens University Kingston Ontario Canada

    Sponsors and Collaborators

    • Queen's University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Mohammad Auais, PhD, Assistant Professor, School Of Rehabilitation Therapy, Queen's University
    ClinicalTrials.gov Identifier:
    NCT05965011
    Other Study ID Numbers:
    • 6030812
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Mohammad Auais, PhD, Assistant Professor, School Of Rehabilitation Therapy, Queen's University
    Fear of Falling
    Nordic Walking
    Older adults

    Study Results

    No Results Posted as of Aug 1, 2023