Clinical trial NCT05965011: Nordic Walking to Manage Falls and Fear of Falling
Official title: Walking on 'Four Legs' to Manage Falls and Fear of Falling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk of Falling
Keywords: Fear of Falling
Nordic Walking
Older adults
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 37
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a pilot trial conducted as a two-arm, parallel, single-blind, randomized controlled trial.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimate the effect size of intervention (Cohen's D)
timeFrame: Through study completion, an average of 1.5 years
measure: Evaluate the adherence rate to the intervention (as a measure of feasibility)
timeFrame: Through study completion, an average of 1.5 years
measure: Assess safety of the intervention
timeFrame: Through study completion, an average of 1.5 years
Secondary outcomes:
measure: Timed Up and Go (TUG) to assess fall risk
timeFrame: Pre (week 0) /post intervention (week 11)
measure: Fear of Falling: Fear of falling will be measured by the Falls Efficacy Scale-International (FES-I)
timeFrame: Pre (week 0) /post intervention (week 11)
measure: Performance on the Four-Square Step Test (FSST) will be measured to assess balance.
timeFrame: Pre (week 0) /post intervention (week 11)
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: School of Rehabilitation Therapy, Queens University
state: Ontario
Study officials:
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