Exercise Guidance for Parkinson's Disease

Enrolling by invitation at 3 trial locations

Overseen By Michelle Walaszek, PT, DPT, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Dementia, Mild cognitive impairment, others

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

Compensation: Varies

Number of Visits: 7

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of exercise guidance can help people with Parkinson's Disease remain active. It compares three approaches: standard care, written exercise advice from a neurologist, and physical therapy. Participants will use activity trackers and a mobile app to monitor their exercise over a year. The trial suits those diagnosed with Parkinson's Disease who can walk without a walker and are willing to use a smartphone app regularly. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve exercise strategies for Parkinson's patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these exercise guidance strategies are safe for people with Parkinson's Disease?

Research has shown that physical therapy is a safe and well-tolerated treatment for people with Parkinson's Disease, often recommended to help manage movement problems. Studies have found no obvious risks associated with physical therapy for these patients.

Additionally, research suggests that exercise, when advised by neurologists, is safe and beneficial for people with Parkinson's. Exercise can aid in movement issues and improve mood and energy levels.

Overall, both physical therapy and exercise guidance from neurologists are low-risk options for managing Parkinson's Disease. They are important tools for improving the quality of life for those living with the condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to help people with Parkinson's Disease manage their symptoms through exercise. Unlike the usual treatments, which often include medications like levodopa or dopamine agonists, this trial focuses on non-drug approaches. One unique aspect is the written exercise guidance provided by neurologists, tailored specifically for Parkinson's patients, which could empower patients to take an active role in their care. Additionally, the trial is testing a consultative model of physical therapy, which might offer a more personalized and proactive approach compared to standard care. These methods aim to enhance mobility and quality of life, potentially offering benefits without the side effects associated with medications.

What evidence suggests that this trial's exercise guidance strategies could be effective for Parkinson's Disease?

Research has shown that physical therapy, one of the treatments under study in this trial, can greatly benefit people with Parkinson's Disease (PD). Studies have found that ongoing physical therapy can improve movement problems and may even reduce the need for medication. It might also help slow the disease's progression.

This trial will compare physical therapy with written exercise guidance provided by a neurologist, another treatment arm in the study. Research indicates that regular and structured exercise can enhance motor skills and balance in people with PD. Aerobic exercise, in particular, has been linked to better movement and balance. Staying physically active over time is also associated with better overall health outcomes for those with PD. ^{2 6 7 8 9}

Who Is on the Research Team?

Miriam Rafferty, PT, DPT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for people aged 18-89 with Parkinson's Disease at stages 1-3 who can walk and understand basic English. They must have a smartphone, agree to use an activity tracker app every few days, and accept the app's terms. Those with dementia or mobility issues requiring a rollator are excluded.

Inclusion Criteria

My Parkinson's disease is in the early to mid-stage.

Have a smart phone

Willing to sync activity tracker with Datos health app at least every 3 days

Exclusion Criteria

You have been diagnosed with memory or thinking problems in your medical records.

You have other health issues that make it hard for you to exercise for more than 12 weeks.

I use a rollator or rolling walker to move around.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Baseline Assessment

Participants complete baseline assessments and are provided with activity trackers

1 week

1 visit (in-person)

Treatment

Participants engage in exercise and physical activity tracking with different guidance strategies

12 months

5 visits (virtual) at 3-month intervals

Follow-up

Participants are monitored for changes in physical activity and exercise behaviors

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical therapy
• Written exercise guidance by neurologist

Trial Overview The study compares three ways of encouraging exercise in Parkinson's patients: usual care, written instructions from their neurologist, and physical therapy sessions. Participants will track their activity using wearables and an app over one year.

How Is the Trial Designed?

Group I: Physical therapy Experimental Treatment 1 Intervention

A consultative model of physical therapy will be implemented at each site for patient's with Parkinson's Disease.

Group II: Written exercise guidance by neurologist Active Control 1 Intervention

Neurologists will provide written exercise education and guidance to their patients with Parkinson's Disease.

Group III: Standard Care Active Control 1 Intervention

Standard care patient's with Parkinson's Disease are receiving at each site.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Northwestern Lake Forest Hospital

Collaborator

Trials

1

Recruited

290+

Northwestern Medicine

Collaborator

Trials

14

Recruited

9,500+

Published Research Related to This Trial

The proactive physical therapy (PAPT) program for people with Parkinson disease (PD) was successfully implemented at a rehabilitation center, targeting individuals before significant mobility issues arose, and resulted in a doubling of participants engaging in regular exercise over six months.

Participants in the PAPT program reported substantial physical and emotional benefits, with a notable increase in aerobic exercise participation and balance activities, highlighting the program's effectiveness in promoting long-term independent exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Implementation Frameworks to Provide Proactive Physical Therapy for People With Parkinson Disease: Case Report. Rafferty, MR., MacDonald, J., Byskosh, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8609713/

Effectiveness of Long-Term Physiotherapy in Parkinson's ... This review provided evidence that long-term physiotherapy has beneficial impact on motor symptoms and antiparkinsonian medication dose in PD patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7564288/

Physiotherapy in Parkinson's Disease: A Meta-Analysis of ... This meta-analysis provides a comprehensive overview of the evidence for the effectiveness of different physiotherapy interventions in the management of PD.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2807484

Type, Timing, Frequency, and Durability of Outcome ... This systematic review and meta-analysis of 46 randomized clinical trials of 3905 patients with PD found no differences between standard and nonstandard PT in ...

4. nature.com nature.com/articles/s41531-025-01069-x

Effects of specialised physiotherapy on mortality in ... These findings suggest that specialised physiotherapy for PD-related indications may delay death in persons with PD.

5. academic.oup.com academic.oup.com/ptj/article/102/4/pzab302/6485202

Physical Therapist Management of Parkinson Disease The Academy of Neurologic Physical Therapy developed outcome measures in the Parkinson Evidence Database to Guide Effectiveness (PDEDGE).16 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9046970/

Physical Therapist Management of Parkinson Disease The Academy of Neurologic Physical Therapy developed outcome measures in the Parkinson Evidence Database to Guide Effectiveness (PDEDGE).

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

Physical exercise for people with Parkinson's disease The evidence is very uncertain about the effect of physical exercise on the risk of adverse events (very low confidence). Across outcomes, we ...

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01616-w

Is physical therapy recommended for people with parkinson's ... In conclusion, the PT is a safe intervention that can prescribed to PwPD receiving STN-DBS to maximize clinical improvements. Even though ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S183695532100045X

Physiotherapy management of Parkinson's disease Physiotherapists play a very important role in the rehabilitation of people with PD, particularly in relation to the management of motor symptoms.