Walking on 'Four Legs' to Manage Falls and Fear of Falling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Assess safety of the intervention
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The single-blind design will involve that the assessors are unaware of the group assignments.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Exercise training (Other)
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.
结局指标
主要结局
Assess safety of the intervention
时间窗: Through study completion, an average of 1.5 years
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.
Estimate the effect size of intervention (Cohen's D)
时间窗: Through study completion, an average of 1.5 years
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.
Evaluate the adherence rate to the intervention (as a measure of feasibility)
时间窗: Through study completion, an average of 1.5 years
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.
次要结局
- Fear of Falling: Fear of falling will be measured by the Falls Efficacy Scale-International (FES-I)(Pre (week 0) /post intervention (week 11))
- Timed Up and Go (TUG) to assess fall risk(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))
研究者
Dr. Mohammad Auais, PhD
Assistant Professor, School Of Rehabilitation Therapy
Queen's University