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High-Intensity Treadmill Exercise for Parkinson's Disease (SPARX3 Trial)

N/A
Recruiting
Led By Daniel M Corcos, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hoehn and Yahr stages less than 3
Age 40-80 years
Must not have
(For women only) Actively breast-feeding an infant, and/or pregnant, or plan to become pregnant in the next 12 months.
Individuals with orthostatic hypotension and standing systolic BP below 100 will be excluded. Orthostatic hypotension (OH) is a reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of standing.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether high-intensity endurance treadmill exercise can help slow the progression of Parkinson's disease in people who have not yet started medication for PD. 370 participants will be randomly assigned to 1 of 2 groups and exercise 4 times per week for 12 months. The primary objective is to see if the progression of PD signs is slowed at 12 months in the group exercising at a higher intensity.

Who is the study for?
This trial is for people aged 40-80 with early-stage Parkinson's disease (diagnosed within the last 3 years and not severe), who haven't started medication. They must have a positive DaTscan, be able to exercise, and not have other serious health issues or recent use of certain medications that could interfere with the study.
What is being tested?
The study tests if high-intensity treadmill exercise can slow down Parkinson's symptoms over a year. Participants are randomly placed in two groups: one does moderate-intensity workouts, while the other does high-intensity workouts, both four times per week.
What are the potential side effects?
Since this trial involves physical exercise, potential side effects may include muscle soreness, fatigue, joint pain or risk of falls. However, these will vary based on individual fitness levels and the intensity of workout sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Parkinson's disease is in the early or mid-stage.
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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently breastfeeding, pregnant, or plan to be pregnant soon.
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My blood pressure does not drop significantly when I stand up.
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My thyroid, liver, or kidney functions are not normal.
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I am allergic to DaTscan™ or its ingredients.
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I haven't been hospitalized or needed serious treatment in the last month.
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My blood pressure is not higher than 150/90 mmHg.
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My MoCA score is below 24, indicating cognitive challenges.
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I haven't used neuroleptics or dopamine blockers in the last 30 days.
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I am currently taking medication for Parkinson's disease.
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I haven't taken specific medications that could affect brain scans in the last 90 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in activity
Change in blood derived marker of inflammation
Change in blood derived marker of neuronal development
+7 more
Other study objectives
Change in stride length
Change in turning velocity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High Intensity ExerciseExperimental Treatment1 Intervention
Treadmill exercise 4x per week at 80-85% HRmax.
Group II: Moderate Intensity ExerciseActive Control1 Intervention
Treadmill exercise 4x per week at 60-65% HRmax.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treadmill walking
2008
N/A
~230

Find a Location

Who is running the clinical trial?

The Parkinson Study GroupNETWORK
16 Previous Clinical Trials
32,131 Total Patients Enrolled
University of PittsburghOTHER
1,789 Previous Clinical Trials
16,359,253 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,645 Previous Clinical Trials
958,224 Total Patients Enrolled

Media Library

Treadmill walking Clinical Trial Eligibility Overview. Trial Name: NCT04284436 — N/A
Parkinson's Disease Research Study Groups: Moderate Intensity Exercise, High Intensity Exercise
Parkinson's Disease Clinical Trial 2023: Treadmill walking Highlights & Side Effects. Trial Name: NCT04284436 — N/A
Treadmill walking 2023 Treatment Timeline for Medical Study. Trial Name: NCT04284436 — N/A
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04284436 — N/A
~167 spots leftby Jul 2027
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