What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include medications like levodopa, dopamine agonists, and MAO-B inhibitors, which can cause side effects such as nausea, dizziness, and dyskinesia. For non-pharmacological treatments similar to the Telehealth-Delivered Physical Activity Coaching, such as structured exercise programs, side effects are generally minimal but can include muscle soreness, fatigue, and the risk of falls or injuries if not properly supervised. Overall, exercise is well-tolerated and beneficial for improving motor symptoms and quality of life in PD patients.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Parkinson's Disease, primarily focusing on managing motor symptoms. These include levodopa (often combined with carbidopa), dopamine agonists (such as pramipexole and ropinirole), MAO-B inhibitors (like selegiline and rasagiline), and COMT inhibitors (entacapone). These medications aim to replenish or mimic dopamine, the neurotransmitter deficient in PD. In contrast, non-pharmacological interventions like the Telehealth-Delivered Physical Activity Coaching focus on structured support and individualized coaching to enhance physical activity, which has shown promise in improving motor performance and overall quality of life in PD patients. While these exercise-based interventions are not FDA-approved treatments, they complement pharmacological therapies by addressing non-motor symptoms and promoting overall well-being.

What other types of research exist?

Promising alternatives to telehealth-delivered physical activity coaching for Parkinson's Disease patients include: 1) Mobile apps with personalized exercise plans and real-time feedback, such as those incorporating AI to adapt exercises based on patient progress. 2) Virtual reality (VR) exercise programs that provide immersive environments to enhance engagement and motivation. 3) Wearable technology that monitors physical activity and provides data-driven insights and personalized recommendations. 4) Community-based exercise programs with peer support groups to encourage social interaction and adherence. These alternatives leverage technology and social support to provide structured, individualized physical activity interventions.

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Physical Activity Coaching for Parkinson's Disease (Engage-PD Trial)

Phase 1

Waitlist Available

Research Sponsored by Teachers College, Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves physical activity coaching rather than medication, side effects are minimal but may include typical exercise-related issues such as muscle soreness or fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brunel Lifestyle Physical Activity Questionnaire

Self-Efficacy for Exercise Scale

Secondary study objectives

Acceptability questionnaire (open-ended questions)

Brief Pain Inventory

International Physical Activity Questionnaire (Short-Form Phone version)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Activity Coaching

2017

Completed Phase 2

~20

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Physical activity and exercise-based interventions for Parkinson's Disease (PD) primarily work by improving motor function, enhancing neuroplasticity, and increasing overall physical fitness. These activities help to counteract the motor symptoms of PD, such as bradykinesia, rigidity, and postural instability, by promoting better muscle strength, coordination, and balance. Additionally, exercise can stimulate the release of neurotrophic factors, which support the survival and growth of neurons, potentially slowing disease progression. For PD patients, maintaining physical activity is crucial as it can improve quality of life, reduce the risk of falls, and enhance the effectiveness of other treatments. Programs like Telehealth-Delivered Physical Activity Coaching provide structured support and individualized coaching, making it easier for patients to adhere to exercise regimens and achieve these benefits.

Feasibility and longitudinal effects of repeated participation in an annual, brief and intense exercise program in individuals with Parkinson's disease: A case report.Effectiveness of physical activity on patients with depression and Parkinson's disease: A systematic review.Effects of twelve weeks of aerobic or strength training in addition to standard care in Parkinson's disease: a controlled study.