Clinical trial NCT06915987: Parkinson Disease and Exercise Snacks
Official title: Exercise Snacks for People With Parkinson Disease: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Exercise Snacks
Exercise Intervention
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

This is an unblinded, block-randomized parallel-group clinical trial involving 40 male and female adults with clinically established PD. Participants will be recruited from Kelowna, British Columbia, through the Humphrey's Family Movement Disorder Clinic and local PD patient support groups. The trial aims to be inclusive, ensuring that the interventions are safe and accessible for a diverse participant population.

Participants with a clinical diagnosis of Parkinson Disease will be randomized to Exercise Snack or Active Movement breaks. Specific hypotheses are: 1) participants in the Exercise Snacks and Active Movement Break groups will be highly adherent to the prescribed activity and 2) people with PD randomized to the Exercise Snacks group will experience improvements in walking performance, reduced fear of falling, and enhanced quality of life compared to the Active Movement Breaks group.

Estimates of the effect of either randomized group assignment includes 1) functional mobility measures (Timed Up and Go, walking speed, balance scales) and 2) psychosocial measures (psychological well-being, fear of falling, quality of life). These will be assessed pre- and post- intervention.

Overall objectives to the study include:

1. to conduct a 12-week pilot randomized controlled trial (RCT) comparing Exercise Snacks to a placebo exercise intervention (Active Movement Breaks) in people with PD
2. measure changes in patient-reported activity levels, fear of falling, quality of life, and clinical measures of walking performance and balance
3. evaluate feasibility outcomes to guide scalability for a fully powered RCT
4. identify barriers and facilitators for exercise snacks in PD patient population using participant-orientated, qualitative study review
5. determine eligibility, recruitment, adherence, and dropout rates for a study of this design

This comprehensive Snack PD pilot design will provide robust evidence on the feasibility and efficacy of exercise snacks for people with PD, informing future large-scale trials and broader implementation strategies.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion criteria

* 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.

Primary outcomes:
measure: Feasibility of Intervention: completion rate
timeFrame: 10 weeks
measure: Feasibility of Intervention: rate of perceived exertion
timeFrame: 10 weeks
measure: Feasibility of Intervention: exercise enjoyment scale
timeFrame: 10 weeks
measure: Adherence to the Intervention: completion rate
timeFrame: 10 weeks
measure: Adherence to the Intervention: rate of perceived exertion
timeFrame: 10 weeks
measure: Adherence to the Intervention: exercise enjoyment scale
timeFrame: 10 weeks
Secondary outcomes:
measure: Qualitative Study Review; perceived acceptability of the intervention using a descriptive, open-ended questionnaire.
timeFrame: 12 weeks
measure: Qualitative Study Review; the identification of barriers or facilitators to the study using a descriptive, open-ended questionnaire.
timeFrame: 12 weeks
measure: Qualitative Study Review; participant assessment of the 7 Movements App and technology using a descriptive, open-ended questionnaire.
timeFrame: 12 weeks
measure: Qualitative Study Review; study safety concerns as expressed by participants using a descriptive, open-ended questionnaire.
timeFrame: 12 weeks
measure: Actigraphy: heart rate measures (bpm).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Daryl J Wile, MD
role: PRINCIPAL_INVESTIGATOR
References: