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NCT00194701 · ClinicalTrials.gov registry record · Phase 3
Exercise to Improve Sleep in Heart Failure
A Phase 3 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 3
- Development phase
- 152
- Enrollment target
NCT00194701 is a Phase 3 study that has completed, run by University of Washington. The registered enrollment target is 152 participants.
The verdict
NCT00194701, a Phase 3 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 152 participants
- Enrollment target
Study Summary
Of the more than 2 million Americans with heart failure (HF), up to 70% have disturbed sleep that worsens the dyspnea, fatigue, and reduced daytime function associated with HF. Exercise improves sleep in healthy people but the effects of exercise have not been tested in patients with HF. A controlled, randomized trial is proposed to compare the effects of 16 weeks of usual activity (control) with 16 weeks of regular, supervised walking exercise (treatment), on cardiac function and sleep. Approximately 170 subjects with NYHA Class I, II, or III stable heart failure will be recruited. Subjects in the treatment group will walk for exercise up to 5 times a week for up to 30 minutes. The purpose of this randomized trial is to examine the effects of 16 weeks of regular walking exercise on cardiac function, sleep, and quality of life in persons with stable New York Heart Association (NYHA) Class I, II or III heart failure. The specific aims are: 1. To compare the physiologic measures of cardiac function (peak oxygen utilization, exercise capacity, nocturnal arterial oxygen desaturations, and heart rate variability) and self-reported quality of life (i.e., symptoms of dyspnea and fatigue, and the ability to perform activities of daily living) of patients randomized to walking vs. control condition. 2. To compare the somnographic (sleep fragmentation, slow wave sleep, sleep efficiency) and self-reported (sleep effectiveness, sleep disturbance, and nap supplementation) measures of sleep for HF patients randomized to walking vs. control condition. 3. Considering the extent of apnea-hypopnea episodes at study entry and group assignment (walking vs. control), explore whether HF patients with frequent apnea-hypopnea episodes (more than 20 per hour) in the walking group experience greater pretest-posttest improvements in physiologic cardiac and somnographic function, when compared with HF patients with few apnea-hypopnea episodes (less than 20 per hour) assigned to walking, or
Interventions
- BEHAVIORAL Walking exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 1998-04 |
| Est. Completion | 2002-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00194701
The ClinicalTrials.gov registry entry for NCT00194701 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Walking exercise is the first listed.
NCT00194701 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00194701 about?
NCT00194701 is a clinical study titled "Exercise to Improve Sleep in Heart Failure". Of the more than 2 million Americans with heart failure (HF), up to 70% have disturbed sleep that worsens the dyspnea, fatigue, and reduced daytime function associated with HF. Exercise improves sleep in healthy people but the effects of exercise have not been tested in patients with HF. A controlle...
What is the current status of trial NCT00194701?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 1998-04. Estimated completion is 2002-03.
What interventions are being tested in trial NCT00194701?
The interventions under investigation include: Walking exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT00194701?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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