100 Participants Needed

Physical Activity Coaching for Parkinson's Disease

(Engage-PD Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Teachers College, Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on physical activity coaching for Parkinson's disease.

What data supports the effectiveness of the treatment Physical Activity Coaching for Parkinson's Disease?

Research shows that physical activity counseling can help improve symptoms like fatigue and depression in people with multiple sclerosis, suggesting it might also be beneficial for Parkinson's Disease. Additionally, physical activity interventions have been promising in managing chronic diseases, indicating potential benefits for Parkinson's patients.12345

Is physical activity coaching safe for people with Parkinson's disease?

While exercise and physical activity are generally beneficial for people with Parkinson's disease, many studies do not report on safety or adverse events. However, supervised programs are common, suggesting a focus on safety, and high retention rates indicate participants generally tolerate these interventions well.678910

How is Physical Activity Coaching different from other treatments for Parkinson's disease?

Physical Activity Coaching for Parkinson's disease is unique because it focuses on personalized exercise guidance to help patients overcome barriers and set realistic goals, potentially altering disease progression. Unlike traditional treatments, it emphasizes long-term engagement in physical activity through expert or peer coaching, often using telehealth or mobile health (mHealth) platforms.611121314

What is the purpose of this trial?

This trial tests a video call-based exercise coaching program for people with early to mid-stage Parkinson's disease. A therapist helps patients set exercise goals, track their progress, and stay motivated. The aim is to increase daily activity and improve overall health.

Eligibility Criteria

The Engage-PD trial is for people with early to mid-stage Parkinson's disease who can walk indoors and outdoors without help or devices, have passed a physical activity readiness test or got medical clearance, and have a neurologist-confirmed diagnosis. It's not for those with musculoskeletal injuries that stop them from exercising or other neurological conditions like stroke.

Inclusion Criteria

Ambulatory for indoor and outdoor mobility without assistance or assistive device
Successful completion of Physical Activity Readiness Questionnaire (PAR-Q)26 or medical clearance from GP
Neurologist confirmed clinical diagnosis for Parkinson's disease Hoehn & Yahr stage I-III

Exclusion Criteria

You have a muscle or bone injury that would stop you from taking part in an exercise program.
You have a neurological condition such as a stroke or other disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person or virtual)

Initial Assessment

Participants undergo a brief evaluation including history, contraindications for exercise, and various assessments

1 week
1 visit (in-person or virtual)

Treatment

Participants receive up to 5 coaching sessions focusing on physical activity engagement and goal development

3 months
Up to 5 sessions (virtual)

Follow-up

Participants are monitored for progress and barriers to exercise engagement, with assessments repeated at 3 and 6 months

6 months
2 follow-up assessments (virtual)

Treatment Details

Interventions

  • Physical Activity Coaching
Trial Overview This study tests a telehealth-delivered physical activity coaching program led by therapists. The goal is to provide personalized support to encourage exercise as part of self-management for Parkinson's patients, based on prior research in similar diseases.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Physical Activity CoachingExperimental Treatment1 Intervention
Participants will receive up to 5 coaching sessions by a physical or occupational therapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit or other device to monitor their heart rate and physical activity during the course of the intervention period.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Teachers College, Columbia University

Lead Sponsor

Trials
27
Recruited
6,100+

Columbia University

Collaborator

Trials
1,529
Recruited
2,832,000+

Findings from Research

A study analyzing 20 websites for physical activity information for people with multiple sclerosis (MS) found that they covered an average of only 8 out of 20 behavior change techniques, indicating a lack of comprehensive resources.
The overall quality and coverage of the information were low, with average scores of 0.64 and 0.62 on a scale of 0 to 2, suggesting that improvements are needed in how these techniques are presented online to better support individuals with MS.
Evaluating the theoretical content of online physical activity information for people with multiple sclerosis.Shirazipour, CH., Baillie, CP., Galaviz, K., et al.[2020]
A study involving 64 individuals with multiple sclerosis showed that telephone counseling combined with home monitoring significantly reduced fatigue and depression compared to self-directed physical activity education.
Participants receiving telephone counseling reported a 33.3% improvement in fatigue and a 53.3% improvement in depression, highlighting the effectiveness and high feasibility of this intervention, as nearly all participants completed their scheduled sessions.
Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling.Turner, AP., Hartoonian, N., Sloan, AP., et al.[2018]
A Parkinson's disease-specific boxing program was well-received by participants, with 81% of patients and 80% of instructors expressing high satisfaction after an initial workshop, indicating strong acceptability of the program.
After 18 months, the program successfully expanded from 10 to 40 participants, with only mild adverse effects reported, suggesting that the program is safe and beneficial for individuals with Parkinson's disease.
Implementation of a Community-Based Exercise Program for Parkinson Patients: Using Boxing as an Example.Domingos, J., Radder, D., Riggare, S., et al.[2020]

References

Development of a physical activity counseling intervention for people with chronic respiratory disease based on the health action process approach. [2023]
Telephone-based physical activity counseling for major depression in people with multiple sclerosis. [2013]
Evaluating the theoretical content of online physical activity information for people with multiple sclerosis. [2020]
Designing trials of behavioral interventions to increase physical activity in patients with COPD: insights from the chronic disease literature. [2022]
Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling. [2018]
Promoting Physical Activity via Telehealth in People With Parkinson Disease: The Path Forward After the COVID-19 Pandemic? [2020]
Implementation of a Community-Based Exercise Program for Parkinson Patients: Using Boxing as an Example. [2020]
Physical Activity in De Novo Parkinson Disease: Daily Step Recommendation and Effects of Treadmill Exercise on Physical Activity. [2021]
Feasibility of a virtual exercise coach to promote walking in community-dwelling persons with Parkinson disease. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Exercise and motor training in people with Parkinson's disease: a systematic review of participant characteristics, intervention delivery, retention rates, adherence, and adverse events in clinical trials. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Exploring Decisions to Undertake a Marathon and Adherence Challenges in a Novice Runner With Parkinson. [2022]
Peer Coaching Through mHealth Targeting Physical Activity in People With Parkinson Disease: Feasibility Study. [2022]
A long-term community gym program for people with Parkinson's disease: a feasibility study of the Monash Health "Health and Fitness" model. [2023]
A Systematic Review on Physical Health Education Interventions for People with Parkinson's Disease: Content, Impact, and Implementation Considerations Across the Parkinson's Trajectory. [2022]
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