Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by The Cleveland Clinic.
NCT04000360 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 256 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function.
Interventions
- OTHER High-Intensity Aerobic Exercise (AE)
- OTHER Usual and Customary Care (UCC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2023-04-30 |
| Phase | NA |
What the finished NCT04000360 record still lists
NCT04000360 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which High-Intensity Aerobic Exercise (AE) is the first listed.
NCT04000360 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04000360's enrollment target sits among peer trials
256 404th of 2000 higher than 1,594 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02464696 · 256 participants · NA
Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
- NCT03793062 · 256 participants
Genetic and Epigenetic Basis of Chronic Wounds
- NCT04322318 · 256 participants · Phase 2
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
- NCT04468360 · 256 participants · Phase 2
Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI