Exercise Guidance for Parkinson's Disease

Recruiting 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

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn about exercise and physical activity people with Parkinson's Disease. The main questions it aims to answer are: 1) learn about the physical activity and exercise behaviors of people with Parkinson's Disease over the course of a year and 2) compare 3 exercise guidance strategies aimed to impact exercise behavior: standard care, written exercise guidance from neurologist and/or physical therapy. During the course of the study: 1. Participants will use activity trackers and a mobile phone application to monitor their exercise participation. 2. At the same time, the research team will be working with the participant's medical teams at Northwestern Medicine and University of Chicago Medical Center to improve the way that they deliver exercise guidance using verbal instructions and encouragement, written exercise guidance, and/or physical therapy.

Will I have to stop taking my current medications?

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

Is physical therapy safe for people with Parkinson's disease?

Physical therapy is generally considered safe for people with Parkinson's disease, as it is recommended in clinical guidelines and involves activities like balance exercises and education, which are non-invasive and low-risk. ^{1 2 3 4 5}

How does exercise guidance differ from other treatments for Parkinson's disease?

Exercise guidance for Parkinson's disease is unique because it focuses on improving movement, balance, and overall physical condition through personalized exercise plans, rather than relying solely on medication or surgery. This approach emphasizes patient education and active participation, which can help maintain independence and delay the need for institutional care. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Physical therapy, PT, Physiotherapy, Rehabilitation Therapy, Written exercise guidance by neurologist for Parkinson's Disease?

Research shows that physiotherapy can positively impact movement-related activities like walking, balance, and posture in people with Parkinson's Disease. It is often recommended alongside medical treatment to help improve physical condition and maintain independence. ^{1 2 3 4 6}

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. Netherlands pubmed.ncbi.nlm.nih.gov

The European Physiotherapy Guideline for Parkinson's Disease: Implications for Neurologists. [2019]

2. Belgium pubmed.ncbi.nlm.nih.gov

[Physical therapy for parkinson's disease]. [2011]

3. Germany pubmed.ncbi.nlm.nih.gov

Physiotherapy in Parkinson's disease: utilisation and patient satisfaction. [2022]

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

Physiotherapy in Parkinson's Disease: Building ParkinsonNet in Czechia. [2022]

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

Using Implementation Frameworks to Provide Proactive Physical Therapy for People With Parkinson Disease: Case Report. [2020]

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

Efficacy of a physical therapy program in patients with Parkinson's disease: a randomized controlled trial. [2022]

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

Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. [2022]