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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: Completed Phase 3 study, sponsored by University of Washington.
NCT00194701 is a Phase 3 study that has completed, run by University of Washington. The registered enrollment target is 152 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00194701 record still lists
NCT00194701 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Walking exercise is the first listed.
NCT00194701 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00194701's enrollment target sits among peer trials
152 1513th of 2000 higher than 484 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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