Nordic Walking to Manage Falls and Fear of Falling

NCT05965011 | Completed DMC

• 1 other identifier: 6030812
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk of Falling

Keywords

Fear of Falling; Nordic Walking; Older adults

Outcome Measures

Primary Outcomes (3)

• Estimate the effect size of intervention (Cohen's D)

  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.

  Through study completion, an average of 1.5 years

• Evaluate the adherence rate to the intervention (as a measure of feasibility)

  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.

  Through study completion, an average of 1.5 years

• Assess safety of the intervention

  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.

  Through study completion, an average of 1.5 years

Secondary Outcomes (3)

• Timed Up and Go (TUG) to assess fall risk

  Pre (week 0) /post intervention (week 11)

• Fear of Falling: Fear of falling will be measured by the Falls Efficacy Scale-International (FES-I)

  Pre (week 0) /post intervention (week 11)

• Performance on the Four-Square Step Test (FSST) will be measured to assess balance.

  Pre (week 0) /post intervention (week 11)

Study Arms (2)

Intervention (Nordic walking)

EXPERIMENTAL

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

Control (phone calls)

NO INTERVENTION

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.

Interventions

Exercise training OTHER

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.

Also known as: Nordic walking

Intervention (Nordic walking)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Mohammad Auais, PhD: lead

Study Sites (1)

School of Rehabilitation Therapy, Queens University

Kingston, Ontario, Canada

Location

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MeSH Terms

Interventions

Exercise; Nordic Walking

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Walking; Locomotion

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The single-blind design will involve that the assessors are unaware of the group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, School Of Rehabilitation Therapy

Model Details: This study will be a pilot trial conducted as a two-arm, parallel, single-blind, randomized controlled trial.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 28, 2023
• Study Start: August 29, 2022
• Primary Completion: October 15, 2023
• Study Completion: November 30, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)