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NCT00678821 · ClinicalTrials.gov registry record · Phase 2
Aerobic Exercise in Patients With Pulmonary Hypertension
A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
NCT00678821 is a Phase 2 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 97 participants.
The verdict
NCT00678821, a Phase 2 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
Study Summary
This study will determine if a rehabilitation exercise program can help people with pulmonary hypertension (PH) increase their physical activity. Patients with PH have an increase in blood pressure in the pulmonary blood vessels (artery, vein or capillaries) that leads to shortness of breath, dizziness, fainting and other symptoms. Healthy volunteers and people with pulmonary hypertension between 21 and 75 years of age may be eligible for this study. All participants undergo the following tests and procedures: * Medical history and physical examination * 6-minute walk test: Subjects walk as fast as they can for 6 minutes on a walking track to determine their ability to participate in physical activity. * Questionnaires: Subjects complete nine questionnaires related to their fatigue, daily physical activity, mood, and so forth. * Maximum treadmill test: The exercise begins at an easy level and gradually increases until the subject says he or she can no longer continue or the investigator decides it is not safe to continue. Subjects are fitted with a mask, electrodes and light sensors to measure how well the heart is working and how well the muscles use oxygen. Patients with pulmonary hypertension undergo the following additional procedures: * Activity monitoring: Patients wear a monitor for 3 days that measures movement and heart rate. * Group assignment: Patients are randomly assigned to Group 1 (education plus aerobic exercise) or Group 2 (education followed by exercise). * Group 1 patients will attend classes three days a week at either Inova Fairfax Hospital Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. Two sessions a week will include a 1 hour education session as well as a 30-45 minute track or treadmill exercise session. The third session will only include exercise. During the education patients will learn about a healthy lifestyle with pulmonary hypertension. After the 10 weeks of education and exercise, subjects repe
Interventions
- OTHER Aerobic exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2008-06-12 |
| Est. Completion | 2015-09-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00678821
The ClinicalTrials.gov registry entry for NCT00678821 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aerobic exercise is the first listed.
NCT00678821 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00678821 about?
NCT00678821 is a clinical study titled "Aerobic Exercise in Patients With Pulmonary Hypertension". This study will determine if a rehabilitation exercise program can help people with pulmonary hypertension (PH) increase their physical activity. Patients with PH have an increase in blood pressure in the pulmonary blood vessels (artery, vein or capillaries) that leads to shortness of breath, dizzin...
What is the current status of trial NCT00678821?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2008-06-12. Estimated completion is 2015-09-23.
What interventions are being tested in trial NCT00678821?
The interventions under investigation include: Aerobic exercise (OTHER).
Who is sponsoring clinical trial NCT00678821?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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