Nordic Walking to Manage Falls and Fear of Falling

Risk of Falling Clinical Trial

Official title:

Walking on 'Four Legs' to Manage Falls and Fear of Falling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05965011
• Other study ID #: 6030812
• Status: Completed
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 30, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Risk of Falling

Intervention

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.

Locations

Country	Name	City	State
Canada	School of Rehabilitation Therapy, Queens University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Mohammad Auais, PhD

Country where clinical trial is conducted

Canada, 

References & Publications (76)

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* Note: There are 76 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Timed Up and Go (TUG) to assess fall risk	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.	Pre (week 0) /post intervention (week 11)
Secondary	Fear of Falling: Fear of falling will be measured by the Falls Efficacy Scale-International (FES-I)	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.	Pre (week 0) /post intervention (week 11)
Secondary	Performance on the Four-Square Step Test (FSST) will be measured to assess balance.	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.	Pre (week 0) /post intervention (week 11)