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临床试验/NCT06915987
NCT06915987尚未招募不适用

Exercise Snacks for People With Parkinson Disease: A Pilot Randomized Controlled Trial

University of British Columbia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Feasibility of Intervention: completion rate

研究概览

简要总结

People with Parkinson's Disease (PD) benefit from exercise, but many face barriers like motor disability, fatigue, and lack of time, leading to reduced activity. This study aims to assess the effectiveness of "exercise snacks," short bursts of vigorous activity that can be done anywhere without equipment or a significant time commitment. These exercise snacks help integrate activity into daily life, making it more accessible for people with PD. The secondary goal is to evaluate the feasibility of this approach through this pilot randomized controlled trial (RCT) to inform a larger, future RCT.

详细描述

Exercise has increasingly become a recognized and valuable component of treatment for individuals with Parkinson's Disease (PD). Numerous studies indicate that exercise can improve motor symptoms, enhance mobility, and contribute to overall well-being. However, despite the well-documented benefits, a significant proportion of people with PD remain inactive. Their physical activity levels often decline over time due to a range of disease-related and practical barriers.

Disease-specific challenges may include motor impairments, fatigue, and apathy. Practical obstacles such as limited time, lack of access to appropriate facilities or programs, adverse weather conditions, and financial constraints also hinder participation. These barriers are compounded in rural and remote communities where exercise resources are scarce. Consequently, there is a pressing need for time-efficient, accessible exercise options adaptable to different stages of PD and feasible for those with varying levels of motor impairment.

Our proposal introduces an innovative intervention called "exercise snacks," consisting of brief, vigorous activity bursts that can be performed anywhere without specialized equipment or a significant time commitment. This approach integrates exercise into daily routines, making it a practical and accessible option for people with PD. Short bouts of exercise are more likely to be maintained and are perceived as more manageable than traditional long-duration workouts. Moreover, this intervention aligns with the World Health Organization Guidelines on Physical Activity and Sedentary Behavior and the Canadian 24-Hour Movement Guidelines for Adults, which encourage breaking up sedentary behavior with short activity breaks.

Exercise interventions must be inclusive to benefit a broader range of people with PD. Many existing studies exclude participants with mild cognitive impairment or those who require assistance with walking or daily activities. Our intervention is specifically designed to accommodate a wide range of abilities. With remote delivery through the Seven Movements platform, the intervention can reach participants in rural or remote areas, where access to traditional exercise programs is limited. This is particularly beneficial in the Interior of British Columbia, where a higher proportion of rural residents face significant healthcare disparities.

Evidence from other populations suggests that exercise snacks can significantly improve cardiovascular fitness and overall health outcomes. High-intensity interval training (HIIT) and similar time-efficient exercise programs have demonstrated comparable benefits to longer-duration aerobic training. We theorize that exercise snacks will offer similar advantages for people with PD by enhancing walking performance, reducing fear of falling, and improving quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (19 years of age or older) with Clinically Established PD (Postuma et al., 2015).
  • •Medically cleared to exercise by their physician.
  • •A score of ≤3 on the modified Hoehn & Yahr scale (i.e. physically independent, may have unilateral or bilateral clinical signs, including mild impairment of postural reflexes).
  • •Have access to a computer, tablet, or smartphone with internet connection for intervention delivery and tracking.

排除标准

  • •Comorbid condition with physical disability preventing participation in exercise (i.e., that cannot be accommodated with modifications to the prescribed exercise).
  • •A score of >=4 on the modified Hoehn & Yahr scale (meaning they may be able to stand or walk but are not physically independent; this typically includes a need for gait aids such as a cane or walker)
  • •No access to reliable internet connection.
  • •Are currently participating in another clinical trial that would interfere with the study procedures described.
  • •Have a scheduled event (e.g. medical or surgical procedure, prolonged travel in the next 3-4 months) that would interrupt participation in the study.

研究组 & 干预措施

Exercise Snack

Active Comparator

Participants to receive higher intensity exercise snack exercises

干预措施: Exercise Intervention (Behavioral)

Active Movement Breaks

Placebo Comparator

While not a true placebo (i.e., no intervention at all) participants in this arm will receive low intensity / stretching based exercises throughout the study period.

干预措施: Exercise Intervention (Behavioral)

结局指标

主要结局

Feasibility of Intervention: completion rate

时间窗: 10 weeks

Feasibility of the study intervention by using quantitative data from activities logged in the Seven Movements platform is a primary outcome. The investigators will evaluate this outcome measure of feasibility by looking at multiple variables indicating completion of target exercise. One of the variables used to assess this primary outcome measure of feasibility is activities completion rate of at least 2 sessions five days per week, or 10 per week long block. Threshold values are High (\>70%), moderate (50-69%), or low (\<50%) adherence. This data will be extracted from the 7 Movements App.

Feasibility of Intervention: rate of perceived exertion

时间窗: 10 weeks

Feasibility of the study intervention by using quantitative data from activities logged in the Seven Movements platform is a primary outcome. The investigators will evaluate this outcome measure of feasibility by looking at multiple variables indicating completion of target exercise. One of the variables used to assess this primary outcome measure of feasibility is the intensity of the exercise expecting a rate of perceived exertion (RPE) of \>4/10 on the Borg CR-10 scale for Exercise Snacks. This data will be extracted from the 7 Movements App.

Feasibility of Intervention: exercise enjoyment scale

时间窗: 10 weeks

Feasibility of the study intervention by using quantitative data from activities logged in the Seven Movements platform is a primary outcome. The investigators will evaluate this outcome measure of feasibility by looking at multiple variables indicating completion of target exercise. One of the variables used to assess this primary outcome measure of feasibility a summary of the Exercise Enjoyment Scale ratings of exercises to compare the study groups. This quantitative data will be extracted from the 7 Movements App.

Adherence to the Intervention: completion rate

时间窗: 10 weeks

Adherence of the study intervention will be evaluated using quantitative data from activities logged in the Seven Movements platform is a primary outcome. The investigators will evaluate this outcome measure of adherence by looking at multiple variables indicating completion of target exercise. One of the variables used to assess this primary outcome measure of adherence is activities completion rate of at least 2 sessions five days per week, or 10 per week long block. Threshold values are High (\>70%), moderate (50-69%), or low (\<50%) adherence. This data will be extracted from the 7 Movements App.

Adherence to the Intervention: rate of perceived exertion

时间窗: 10 weeks

Adherence of the study intervention by using quantitative data from activities logged in the Seven Movements platform is a primary outcome. The investigators will evaluate this outcome measure by looking at multiple variables indicating completion of target exercise. One of the variables used to assess this outcome measure of adherence is the intensity of the exercise expecting a rate of perceived exertion (RPE) of \>4/10 on the Borg CR-10 scale for Exercise Snacks. This data will be extracted from the 7 Movements App.

Adherence to the Intervention: exercise enjoyment scale

时间窗: 10 weeks

Adherence of the study intervention by using quantitative data from activities logged in the Seven Movements platform is a primary outcome. The investigators will evaluate this outcome measure of by looking at multiple variables indicating completion of target exercise. One of the variables used to assess this primary outcome measure of adherence is a summary of the Exercise Enjoyment Scale ratings of exercises to compare the study groups. This data will be extracted from the 7 Movements App.

次要结局

  • Qualitative Study Review; perceived acceptability of the intervention using a descriptive, open-ended questionnaire.(12 weeks)
  • Qualitative Study Review; the identification of barriers or facilitators to the study using a descriptive, open-ended questionnaire.(12 weeks)
  • Qualitative Study Review; participant assessment of the 7 Movements App and technology using a descriptive, open-ended questionnaire.(12 weeks)
  • Qualitative Study Review; study safety concerns as expressed by participants using a descriptive, open-ended questionnaire.(12 weeks)
  • Actigraphy: heart rate measures (bpm).(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daryl Wile

Clinical Investigator, UBC Southern Medical Program CCDPM Clinical Associate Professor, UBC Dept. Medicine, Div. Neurology

University of British Columbia

研究点 (1)

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