Heart FailurePhase 3NCT00194701
Exercise to Improve Sleep in Heart Failure
A Phase 3 study testing Walking exercise in people with Heart Failure, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Walking exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to Mar 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington
Seattle, Washington, 98195-7266
About this study
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.
Read more
The specific aims are:
- 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.
- 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.
- 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.
HYPOTHESES:
- Heart failure patients who walk regularly will have better cardiac function than the control group. Heart failure patients who walk regularly will have higher self-reported quality of life, less shortness of breath/fatigue, and greater ability to perform activities of daily living than the control group.
- Heart failure patients who walk regularly will have better sleep than the control group.
- 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.
Heart failure patients with frequent apnea-hypopnea episodes who walk regularly will have a greater improvement (i.e., larger difference) in pretest-posttest somnographic sleep measures of efficient, fragmented, and slow wave sleep, than heart failure patients with few apnea-hypopnea episodes who walk regularly, or the control groups with frequent or few apnea-hypopnea episodes.
Read the 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 intervention is based on exercise programs adapted from 12 research protocols for patients with NYHA Class II-III heart failure, one cardiac rehabilitation protocol in use for approximately 20 years; and the AHCPR Clinical Practice Guidelines for activity prescriptions for heart failure patients. The walking exercise prescription is based on a modified Naughton treadmill test and a 6-minute walk test, both conducted as part of eligibility screening and used as pretest measures. The target exercise heart rate range is calculated from the peak heart rate (measured on treadmill at the peak of oxygen utilization) minus the resting heart rate, multiplied by 40% to 60%, plus the resting heart rate. Weekly for 6 weeks, and then every other week for 10 weeks, the research nurse makes visits to initiate, monitor, and advance an individualized program of walking exercise.
POPULATION. Our target population was persons diagnosed with heart failure (HF).
Pretest and posttest measures include an exercise tolerance test; two nights of somnographic sleep and oxygen saturation recordings; one 24-hour recording of heart rate variability; and subjective reports of quality of life. One-way analyses of variances (ANOVA) will be used to test for control-treatment group differences in cardiac function (Aim 1) and sleep (Aim 2). Interaction will be examined in a two-way ANOVA of group (HF subjects with frequent vs. few apnea-hypopnea episodes walking vs.control) and time (before and after condition) to determine whether HF subjects with frequent apnea-hypopnea episodes who exercise have better outcomes than HF subjects with few apnea-hypopnea episodes who exercise, or the control group (Aim 3).
- Conditions
- Heart Failure
- Being tested
- Walking exercise
- Keywords
- heart failure, sleep, exercise, heart rate variability
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 1998
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Sandra A Motzer, PhD, RN, Principal investigator, University of Washington School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194701
- Sponsor's protocol ID
- 97-4765-D09
- Other IDs
- HL60042
- Status last verified
- Jan 2008
- First submitted
- 13 Sep 2005
- Last updated
- 11 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise to Improve Sleep in Heart Failure
- ClinicalTrials.gov ID
- NCT00194701
- Acronym / sponsor ID
- 97-4765-D09
- Conditions
- Heart Failure
- Keywords
- heart failure, sleep, exercise, heart rate variability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1998
- Study completion
- Mar 2002
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
HYPOTHESES:
- Heart failure patients who walk regularly will have better cardiac function than the control group. Heart failure patients who walk regularly will have higher self-reported quality of life, less shortness of breath/fatigue, and greater ability to perform activities of daily living than the control group.
- Heart failure patients who walk regularly will have better sleep than the control group.
- 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.
Heart failure patients with frequent apnea-hypopnea episodes who walk regularly will have a greater improvement (i.e., larger difference) in pretest-posttest somnographic sleep measures of efficient, fragmented, and slow wave sleep, than heart failure patients with few apnea-hypopnea episodes who walk regularly, or the control groups with frequent or few apnea-hypopnea episodes.
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 intervention is based on exercise programs adapted from 12 research protocols for patients with NYHA Class II-III heart failure, one cardiac rehabilitation protocol in use for approximately 20 years; and the AHCPR Clinical Practice Guidelines for activity prescriptions for heart failure patients. The walking exercise prescription is based on a modified Naughton treadmill test and a 6-minute walk test, both conducted as part of eligibility screening and used as pretest measures. The target exercise heart rate range is calculated from the peak heart rate (measured on treadmill at the peak of oxygen utilization) minus the resting heart rate, multiplied by 40% to 60%, plus the resting heart rate. Weekly for 6 weeks, and then every other week for 10 weeks, the research nurse makes visits to initiate, monitor, and advance an individualized program of walking exercise.
POPULATION. Our target population was persons diagnosed with heart failure (HF).
Pretest and posttest measures include an exercise tolerance test; two nights of somnographic sleep and oxygen saturation recordings; one 24-hour recording of heart rate variability; and subjective reports of quality of life. One-way analyses of variances (ANOVA) will be used to test for control-treatment group differences in cardiac function (Aim 1) and sleep (Aim 2). Interaction will be examined in a two-way ANOVA of group (HF subjects with frequent vs. few apnea-hypopnea episodes walking vs.control) and time (before and after condition) to determine whether HF subjects with frequent apnea-hypopnea episodes who exercise have better outcomes than HF subjects with few apnea-hypopnea episodes who exercise, or the control group (Aim 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking exercise | Behavioural | – |
Primary outcome
Somnographic and self-reported measures of sleep.
1 secondary outcome
Physiologic measures of cardiac function and self-reported holistic and health-related quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra A Motzer, PhD, RN principal investigator
University of Washington School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Walking exercise in people with Heart Failure, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somnographic and self-reported measures of sleep.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2008.