Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
37 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-08-29
Study Completion Date
2023-11-30
Brief Summary
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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.
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
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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.
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.
Conditions
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Risk of Falling
Keywords
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Fear of Falling
Nordic Walking
Older adults
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This study will be a pilot trial conducted as a two-arm, parallel, single-blind, randomized controlled trial.
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
The single-blind design will involve that the assessors are unaware of the group assignments.
Study Groups
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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.
Group Type
EXPERIMENTAL
Exercise training
Intervention Type
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.
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
OTHER
Other Intervention Names
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Nordic walking
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Dr. Mohammad Auais, PhD
OTHER
Sponsor Role
lead
Responsible Party
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Dr. Mohammad Auais, PhD
Assistant Professor, School Of Rehabilitation Therapy
Responsibility Role
SPONSOR_INVESTIGATOR
Locations
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School of Rehabilitation Therapy, Queens University
Kingston, Ontario, Canada
Site Status
Countries
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Canada
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6030812
Identifier Type: -
Identifier Source: org_study_id