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NCT04000360 · ClinicalTrials.gov registry record · NA

Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease

A NA study, sponsored by The Cleveland Clinic.

Completed
Registry status
NA
Development phase
256
Enrollment target

NCT04000360 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 256 participants.

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The verdict

NCT04000360, a NA study, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
NA
Development phase
256 participants
Enrollment target

Study Summary

Identification of an effective disease-modifying intervention (e.g. pharmaceutical, surgical or behavioral) is an unmet need in Parkinson's disease (PD). Increasing evidence indicates high intensity aerobic exercise is a candidate to alter PD progression. The primary aim of this study is to examine the disease-altering capabilities of a long-term, high-intensity aerobic exercise intervention. A multi-site pragmatic randomized controlled trial design has been selected. Individuals with PD will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (UCC). Subjects in the home exercise group will receive an indoor stationary bicycle delivered to their home for a 12 month exercise period. Individuals in the UCC group will continue their current level of physical activity. Motor and non-motor assessments will be conducted at the main campus of the Cleveland Clinic or the University of Utah at enrollment, 6 months, and 12 months. Each assessment will last approximately one hour.

Interventions

  • OTHER High-Intensity Aerobic Exercise (AE)
  • OTHER Usual and Customary Care (UCC)

Trial Details

FieldValue
Enrollment Target 256 participants
Start Date 2019-11-13
Est. Completion 2023-04-30
Phase NA

Sponsor

The Cleveland Clinic

688 total trials

What the Registry Record Tells You About NCT04000360

The ClinicalTrials.gov registry entry for NCT04000360 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which High-Intensity Aerobic Exercise (AE) is the first listed.

NCT04000360 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04000360 about?

NCT04000360 is a clinical study titled "Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease". Identification of an effective disease-modifying intervention (e.g. pharmaceutical, surgical or behavioral) is an unmet need in Parkinson's disease (PD). Increasing evidence indicates high intensity aerobic exercise is a candidate to alter PD progression. The primary aim of this study is to examine ...

What is the current status of trial NCT04000360?

This trial is currently completed. It is a NA study. The enrollment target is 256 participants. The study started on 2019-11-13. Estimated completion is 2023-04-30.

What interventions are being tested in trial NCT04000360?

The interventions under investigation include: High-Intensity Aerobic Exercise (AE) (OTHER), Usual and Customary Care (UCC) (OTHER).

Who is sponsoring clinical trial NCT04000360?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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