Parkinson Disease and Exercise Snacks

NCT06915987 | Not Yet Recruiting

• 1 other identifier: H24-02753
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Exercise Snacks; Exercise Intervention

Outcome Measures

Primary Outcomes (6)

• Feasibility of Intervention: completion rate

  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.

  10 weeks

• Feasibility of Intervention: rate of perceived exertion

  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.

  10 weeks

• Feasibility of Intervention: exercise enjoyment scale

  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.

  10 weeks

• Adherence to the Intervention: completion rate

  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.

  10 weeks

• Adherence to the Intervention: rate of perceived exertion

  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.

  10 weeks

• Adherence to the Intervention: exercise enjoyment scale

  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.

  10 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

Exercise Snack

ACTIVE COMPARATOR

Participants to receive higher intensity exercise snack exercises

Behavioral: Exercise Intervention

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.

Behavioral: Exercise Intervention

Interventions

Exercise Intervention BEHAVIORAL

Exercise snack group will be higher intensity movements designed to elevate heart rate while active movement break will have low intensity / stretching exercises assigned to them.

Also known as: Movement Breaks

Active Movement Breaks; Exercise Snack

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Daryl J Wile, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daryl J Wile, MD

CONTACT

1-250-575-8576; dwile@mail.ubc.ca

Jill M Williamson, PhD

CONTACT

1-250-503-8951; jill.williamson@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator, UBC Southern Medical Program CCDPM Clinical Associate Professor, UBC Dept. Medicine, Div. Neurology

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 8, 2025
• Study Start: May 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: April 1, 2025 until study completion
• Access Criteria: Only those listed on the approved REB application will have access to IPD.

Locations

CA (1)