Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194701
Status:
COMPLETED
Last Update Posted:
2008-01-11
First Post:
2005-09-13
Brief Title:
Exercise to Improve Sleep in Heart Failure
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Exercise to Improve Sleep in Heart Failure
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 ie 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 the control group of HF patients with frequent or few apnea-hypopnea episodes
HYPOTHESES
1 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 breathfatigue and greater ability to perform activities of daily living than the control group
2 Heart failure patients who walk regularly will have better sleep than the control group
3 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 ie 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
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 ie 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 the control group of HF patients with frequent or few apnea-hypopnea episodes
HYPOTHESES
1 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 breathfatigue and greater ability to perform activities of daily living than the control group
2 Heart failure patients who walk regularly will have better sleep than the control group
3 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 ie 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 vscontrol 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
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 vscontrol 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HL60042 | None | None | None |