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NCT01127061 · ClinicalTrials.gov registry record · NA
Study of Exercise Training in Hypertrophic Cardiomyopathy
A NA study of Cardiomyopathy, Hypertrophic, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 136
- Enrollment target
- 2
- Study locations
NCT01127061: Completed NA study of Cardiomyopathy, Hypertrophic, sponsored by University of Michigan.
NCT01127061 is a NA study of Cardiomyopathy, Hypertrophic that has completed, run by University of Michigan. The registered enrollment target is 136 participants, below the 351-participant average among 6 other Cardiomyopathy, Hypertrophic trials with a reported enrollment target (61% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01127061, a NA study of Cardiomyopathy, Hypertrophic, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 136 participants
- Enrollment target
- 2
- Study locations
Study Summary
The investigators propose a pilot randomized controlled trial to determine the safety and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy. The investigators hypotheses are that exercise parameters derived from a baseline cardiopulmonary exercise test will target an appropriately safe level of exercise intensity that will not cause significant arrhythmias or exacerbate symptoms and that exercise training for 4 months will result in significant improvements in peak oxygen consumption (peak VO2) and quality of life, with neutral effects on the clinical characteristics.
Primary Outcome
Cardiopulmonary exercise testing was performed at study enrollment and termination (4 months apart). Peak VO2 was measured at each time point in each subject and change in peak VO2 over time was calculated. The change in Peak VO2 was compared between the study arms.
Conditions Studied
Interventions
- BEHAVIORAL Exercise training
Study Locations (2)
California
- Stanford University - Stanford
Michigan
- University of Michigan Cardiovascular Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2010-04 |
| Est. Completion | 2016-11 |
| Phase | NA |
What the finished NCT01127061 record still lists
NCT01127061 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 351-participant average among 6 other Cardiomyopathy, Hypertrophic trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Cardiomyopathy, Hypertrophic appearing as the primary indexed condition, and to 1 intervention - of which Exercise training is the first listed.
NCT01127061 reports a single indexed study location in California, Michigan.
Frequently Asked Questions
What is clinical trial NCT01127061 about?
NCT01127061 is a clinical study titled "Study of Exercise Training in Hypertrophic Cardiomyopathy". The investigators propose a pilot randomized controlled trial to determine the safety and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy. The investigators hypotheses are that exercise parameters derived from a baseline cardiopulmonary exercise test wi...
What is the current status of trial NCT01127061?
This trial is currently completed. It is a NA study. The enrollment target is 136 participants. The study started on 2010-04. Estimated completion is 2016-11.
What conditions does trial NCT01127061 study?
This clinical trial studies the following conditions: Cardiomyopathy, Hypertrophic.
What interventions are being tested in trial NCT01127061?
The interventions under investigation include: Exercise training (BEHAVIORAL).
Who is sponsoring clinical trial NCT01127061?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01127061 being conducted?
This trial has 2 study locations across California, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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