Exercise to Improve Sleep in Heart Failure

NCT00194701 | Completed Phase 3

• 2 other identifiers: 97-4765-D09HL60042
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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 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. 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. 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. 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 the control group of HF patients with frequent or few apnea-hypopnea episodes.
4. 4.Heart failure patients who walk regularly will have better cardiac function than the control group.
5. 5.Heart failure patients who walk regularly will have better sleep than the control group.
6. 6.Heart failure patients with frequent episodes of slowed or stopped breathing during sleep who walk regularly will have a greater improvement in pretest-posttest measures of cardiac function than heart failure patients with few episodes of slowed or stopped breathing during sleep who walk regularly, or the control groups with frequent or few breathing difficulties during sleep.

Conditions

Heart Failure

Keywords

heart failure; sleep; exercise; heart rate variability

Outcome Measures

Primary Outcomes (1)

• Somnographic and self-reported measures of sleep.

Secondary Outcomes (1)

• Physiologic measures of cardiac function and self-reported holistic and health-related quality of life.

Interventions

Walking exercise BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195-7266, United States

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Sandra A Motzer, PhD, RN

  University of Washington School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 1998
• Study Completion: March 1, 2002
• Last Updated: January 11, 2008

Record last verified: 2008-01

Locations

US (1)