Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965011
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2023-06-15
Brief Title:
Nordic Walking to Manage Falls and Fear of Falling
Sponsor:
Dr Mohammad Auais PhD
Organization:
Queens University
Study Overview
Official Title:
Walking on Four Legs to Manage Falls and Fear of Falling
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Hedges 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 interventions 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 Hedges 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 interventions 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None