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Exercise for Parkinson's Disease (EXCEL-PD Trial)

N/A

Recruiting

Led By Nijee Luthra, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Diagnosis of idiopathic Parkinson's disease (PD) based on MDS criteria, with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism.

Modified Hoehn and Yahr stage less than 4

Must not have

A diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.

A diagnosis of a significant neurological disease other than PD that would interfere with ability to perform study procedures or assessments.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from weeks 5-26, every week

Summary

This trial will study if home-based exercise helps Parkinson's patients, looking at cognitive effects and biomarkers.

Who is the study for?

This trial is for people aged 40-80 with Parkinson's disease who are stable on their PD medications or unlikely to need them in the next 6 months. They should be able to follow exercise instructions without significant cognitive impairment (MoCA score ≥23) and not have severe depression (BDI ≤16). Participants must not have major cardiovascular, metabolic, renal diseases, or other conditions that would make exercising unsafe.

What is being tested?

The study tests a home-based exercise program using high intensity endurance and resistance training for those with Parkinson's. It looks at how this affects cognition and biological markers related to exercise. Some participants will do exercises while others won't, allowing comparison of effects.

What are the potential side effects?

Since the intervention involves physical exercise, potential side effects may include muscle soreness, fatigue, joint pain or injury. However, these are common reactions to starting an exercise routine and usually subside as one adapts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's disease, showing slow movement and either tremor or stiffness.

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My Parkinson's disease is not in the most advanced stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is not primarily Parkinson's disease but may include symptoms similar to it.

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I do not have a major neurological condition other than Parkinson's disease.

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I have not used neuroleptics or dopamine blockers in the last 30 days.

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I haven't been seriously ill or hospitalized in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from weeks 5-26, every week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from weeks 5-26, every week

This trial's timeline: 3 weeks for screening, Varies for treatment, and from weeks 5-26, every week for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Average number of days per week exercised

Average percent heart rate maximum (HR max)

Average repetition maximum

Secondary study objectives

Change in biomarker of aging

Change in biomarker of stress

Other study objectives

Change in cognitive function

Change in fitness

Change in isokinetic strength

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExerciseExperimental Treatment1 Intervention

Participants randomized to the exercise group will receive 26 weeks of home-based, combined endurance and resistance training program under guidance and virtual supervision from exercise trainers. Exercise will be performed 5 days per week, with 3 days of endurance training using treadmill and 2 days of resistance training.

Group II: Waitlist Control GroupPlacebo Group1 Intervention

The control group will continue usual level of physical activity the participants were doing prior to enrollment in the study. At the end of the 26 week study period, participants will be offered the chance to participate in the same home-based, combined endurance and resistance training program.

0 / 7Eligibility criteria met