Status:
COMPLETED
Exercise to Improve Sleep in Heart Failure
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
PROCEDURES. Walking Exercise Intervention. An individualized program of walking exercise is prescribed (walking up to 5 times a week for up to 30 minutes each session). The protocol for this walking i...
Eligibility Criteria
Inclusion
- Classified by the cardiologist, primary physician, or nurse practitioner as having no dyspnea (shortness of breath, air hunger) at rest but fatigue, dyspnea, or anginal (primarily chest/arm/back/neck) pain or discomfort with either ordinary (New York Heart Association classification, NYHA Class II) or less than ordinary (NYHA Class III) physical activity. They could have been Class I (no symptoms) if they were originally diagnosed as having NYHA Class II or III but had responded to treatment.
- Patients must have had evidence of at least one clinical episode of HF diagnosed by a physician or nurse practitioner as fatigue, shortness of breath, and pulmonary congestion.
- Patients had to have stable HF (defined as no hospitalizations for 3 mos, no medication changes for 1 mo, no dyspnea at rest, and no sustained resting heart rate greater than 95 bpm).
Exclusion
- Patients were considered ineligible for the study based on the following criteria obtained from the patient's physician or nurse practitioner:
- Diagnosed with Pickwickian syndrome, an extreme variant of sleep apnea characterized by severe obesity, respiratory insufficiency, and bi-ventricular failure;
- Known obstructive sleep apnea;
- Unstable angina, myocardial infarction, or cardiac surgery 3 mos prior to study entry;
- Aortic stenosis;
- Routine use of theophylline;
- Kyphoscoliosis (spinal curvature) to the extent that chest and abdominal bands used in sleep recordings could not be kept in place;
- Receiving antidepressant therapy;
- Cardiac transplant recipient;
- Psychiatric diagnoses of manic depression, dementia, or depression;
- Inability to walk without assistance;
- Inability to speak/read English;
- Known atrial fibrillation;
- Current use of nocturnal continuous positive airway pressure (CPAP) or oxygen therapy; and
- Already participating in an exercise program meeting or exceeding the level of activity in this study.
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
End Date :
March 1 2002
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00194701
Start Date
April 1 1998
End Date
March 1 2002
Last Update
January 11 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Washington
Seattle, Washington, United States, 98195-7266