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

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{6 11 12 13 14}

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

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+

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.

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Development of a physical activity counseling intervention for people with chronic respiratory disease based on the health action process approach. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Telephone-based physical activity counseling for major depression in people with multiple sclerosis. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluating the theoretical content of online physical activity information for people with multiple sclerosis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Designing trials of behavioral interventions to increase physical activity in patients with COPD: insights from the chronic disease literature. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Promoting Physical Activity via Telehealth in People With Parkinson Disease: The Path Forward After the COVID-19 Pandemic? [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of a Community-Based Exercise Program for Parkinson Patients: Using Boxing as an Example. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Physical Activity in De Novo Parkinson Disease: Daily Step Recommendation and Effects of Treadmill Exercise on Physical Activity. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a virtual exercise coach to promote walking in community-dwelling persons with Parkinson disease. [2022]

10. United States 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Exploring Decisions to Undertake a Marathon and Adherence Challenges in a Novice Runner With Parkinson. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Peer Coaching Through mHealth Targeting Physical Activity in People With Parkinson Disease: Feasibility Study. [2022]

13. England pubmed.ncbi.nlm.nih.gov

A long-term community gym program for people with Parkinson's disease: a feasibility study of the Monash Health "Health and Fitness" model. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

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]