Physical Activity Coaching for Parkinson's Disease

(Engage-PD Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Teachers College, Columbia University

Disqualifiers: Musculoskeletal injury, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if personalized coaching, called Physical Activity Coaching, can help individuals with early to mid-stage Parkinson's disease become more active. The program uses telehealth to connect participants with physical or occupational therapists who guide them to increase daily physical activity and engage in moderate exercise at least three times a week. Participants may use a Fitbit or similar device to track their progress. Ideal candidates have been diagnosed with Parkinson's disease, can walk without assistance, and have no injuries preventing exercise. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to explore this innovative approach.

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 prior data suggests that this physical activity coaching program is safe for people with Parkinson's disease?

Research shows that exercise is generally safe for people with Parkinson's disease. A review of many studies found no negative side effects in 40 studies and no serious side effects in four studies. Exercise helps manage symptoms and improves the quality of life for those with Parkinson's. Additionally, exercise plays an important role in Parkinson's treatment and patients tolerate it well. Therefore, joining a trial that includes exercise coaching is likely safe based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Physical Activity Coaching for Parkinson's Disease because it offers a personalized approach to managing symptoms through structured exercise. Unlike standard treatments like medications (e.g., levodopa) or surgical options, this method focuses on increasing physical activity and setting measurable exercise goals tailored to each individual. By incorporating coaching sessions with therapists and using tools like Fitbits to monitor progress, this approach not only targets physical symptoms but also empowers participants to overcome barriers to staying active. This innovative strategy could lead to improved mobility and quality of life for those with Parkinson's.

What evidence suggests that physical activity coaching is effective for Parkinson's disease?

Studies have shown that physical activity coaching can benefit people with Parkinson's disease (PD). Regular exercise improves their functioning and quality of life. Research indicates that staying active helps manage symptoms and positively influences the disease's progression. One study found that coaching through telehealth programs for PD is feasible and potentially effective. In this trial, participants will receive physical activity coaching, which may help people with Parkinson's stay active and manage their condition more effectively. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Physical Activity Coaching Experimental Treatment 1 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Community-Based Exercise Program for Parkinson Patients: Using Boxing as an Example. Domingos, J., Radder, D., Riggare, S., et al.[2020]

Individuals with Parkinson disease (PD) who take at least 4200 steps daily are significantly more likely to meet physical activity guidelines, being 23 times more likely than those who take fewer steps.

High-intensity treadmill exercise effectively increases daily steps and moderate-to-vigorous physical activity in less active individuals with PD, but these increases do not correlate with improvements in fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity in De Novo Parkinson Disease: Daily Step Recommendation and Effects of Treadmill Exercise on Physical Activity. Handlery, R., Stewart, JC., Pellegrini, C., et al.[2021]

A study involving 20 participants with Parkinson disease showed that using a virtual exercise coach for daily walking resulted in a 100% retention rate and high satisfaction (5.6/7) over one month.

Participants demonstrated significant improvements in mobility, with increased gait speed and performance on the 6-minute walk test, while no adverse events were reported, indicating the intervention's safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a virtual exercise coach to promote walking in community-dwelling persons with Parkinson disease. Ellis, T., Latham, NK., DeAngelis, TR., et al.[2022]

A review of 53 randomized controlled trials on exercise and motor training for Parkinson's disease showed that most interventions were effective and well-supervised, lasting an average of 8.3 weeks, with high participant retention rates (69% retained ≥85% of participants).

However, the lack of detailed reporting on adherence and adverse events in 72% of trials may hinder clinicians' ability to implement these programs effectively in practice, as they need to weigh the benefits against potential risks.

NCBI (Pubmed)

pubmed.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. Allen, NE., Sherrington, C., Suriyarachchi, GD., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling. Turner, AP., Hartoonian, N., Sloan, AP., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36170256/

Physical Activity Coaching via Telehealth for People With ... A telehealth PA coaching program for people with PD was feasible and potentially efficacious. Physical therapist-led coaching may be an ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06962930?locStr=Qatar&country=Qatar&rank=4

An Online Physical Activity Coaching Intervention for ... Regular exercise can improve function and quality of life as well as have other positive behavioral and health-related benefits in people Parkinson's ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000013218

Long-term Effect of Regular Physical Activity and Exercise ... In the long term, the maintenance of high regular physical activity levels and exercise habits was robustly associated with better clinical course of PD.

4. journals.lww.com journals.lww.com/jnpt/fulltext/2025/04000/promoting_physical_activity_in_people_with.3.aspx

Promoting Physical Activity in People With Parkinson's... Physical activity has beneficial symptomatic effects for people with Parkinson's disease (PD), but increasing—and sustaining—a physically active lifestyle ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36602886/

Physical exercise for people with Parkinson's disease We found evidence of beneficial effects on the severity of motor signs and QoL for most types of physical exercise for people with PD ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06962930

An Online Physical Activity Coaching Intervention for ... Regular exercise can improve function and quality of life as well as have other positive behavioral and health-related benefits in people Parkinson's ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/08919887251346495

Physical Activity, Patient-Reported Outcomes, and Quality ... Physical activity has been shown to improve motor symptoms in numerous Parkinson's Disease (PD) clinical trials.

8. jnnp.bmj.com jnnp.bmj.com/content/95/11/1077

Exercise as medicine in Parkinson's disease Exercise is safe and represents a cornerstone in PD rehabilitation, but exercise may have even more fundamental benefits that could change clinical practice.