Effects of exercise training on obstructive and central sleep apnea in coronary artery disease
| ISRCTN | ISRCTN50108373 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50108373 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/09/2014
- Registration date
- 23/09/2014
- Last edited
- 15/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Sleep apnea is a common sleep disorder in which breathing repeatedly stops and starts again as you sleep. There are 2 forms. Obstructive apnea (OSA) happens when the soft tissue at the back of your throat relaxes and blocks your airway. Central apnea (CSA) happens when your brain fails to stimulate your respiratory muscles to breathe. Sleep apnea prevents restful sleep and is linked with cardiovascular disease, including stroke and heart failure. The build-up of fluid in the legs during the day and then the shifting of this fluid into the neck and lungs due to gravity when in bed at night are related to OSA and CSA severity, respectively. Exercise training (ET) reduces the symptoms of sleep apnea, but we do not know why this is the case. The most likely cause, however, is the contraction of the calf muscle; this forces fluid out of the legs and reduces the amount of fluid shifting from the legs to the neck and lungs during sleep. ET in patients with coronary artery disease (CAD) reduces death rates, but again we dont know why. Sleep apnea increases the risk of death for CAD patients. Therefore, it is possible that ET could reduce the risk of death in CAD patients by reducing the severity of sleep apnea. Here, we want to see if ET does reduce OSA and CSA symptoms by reducing the amount of fluid build-up in the legs during the day and its movement into the neck and lungs at night.
Who can participate?
Adults aged between 18-80 with CAD.
What does the study involve?
Participants first undergo a sleep study to see whether they have OSA or CSA. Those that are found to suffer from sleep apnea are then randomly allocated into one of two groups. Those in group 1 do an exercise training programme for 5 days a week for 4 weeks. It includes some moderately intensive aerobic exercise and some light resistance training. Those in group 2 simply wait for a 4 week period. Physical activity levels of all the participants are measured at the start of the study using a actigraphy, an instrument worn on the wrist that measures movement of the body. All participants have the fluid content of their legs, neck and lungs measured and the severity of their sleep apnea assessed at both the beginning and end of the trial.
What are the possible benefits and risks of participating?
Participants that undergo the exercise training program may benefit from an improvement in the severity of their sleep apnea and overall improvement of their cardiovascular health.
Where is the study run from?
Toronto Rehabilitation Institute (Canada)
When is the study starting and how long is it expected to run for?
September 2014 to September 2015
Who is funding the study?
Canadian Institutes of Health Research (Canada)
Who is the main contact?
Dr Monique Mendelson
monique.mendelson@uhn.ca
Contact information
Scientific
550 University Avenue
Toronto
M5G 1X8
Canada
Study information
| Study design | Single-centre randomized controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effects of exercise training on obstructive and central sleep apnea in coronary artery disease: a randomized controlled trial |
| Study objectives | 1. In coronary artery disease patients with obstructive sleep apnea, exercise training will reduce the apnea-hypopnea index in association with decreases in evening leg fluid volume, overnight changes in leg fluid volume and neck fluid volume and an increase in upper-airway cross-sectional area. 2. In coronary artery disease patients with central sleep apnea, exercise training will reduce the apnea-hypopnea index in association with decreases in evening leg fluid volume and overnight change in leg fluid volume and change in thoracic fluid volume, and an increase in PCO2 above the apnea threshold during sleep. |
| Ethics approval(s) | University Health Network Research Ethics Board; 09/09/2014; ref. 14-7748 |
| Health condition(s) or problem(s) studied | Coronary artery disease patients with obstructive or central sleep apnea |
| Intervention | The intervention consists of an exercise training program including 20 sessions over a 4-week period. Each exercise session will begin with a 10 minute warm-up followed by 30 minutes of moderate-intensity aerobic exercise, as recommended by the American College of Sports Medicine and the Canadian Association of Cardiac Rehabilitation. Following aerobic exercise, on non-consecutive days, participants will perform approximately 20 minutes of supervised light resistance training. The intensity of aerobic exercise will be set at 60-80 % of peak oxygen uptake (VO2) or 70-80% heart rate reserve, as determined from the maximum exercise test. The control group does not receive any intervention. They simply wait for a 4-week period. |
| Intervention type | Other |
| Primary outcome measure | Apnea hypopnea index, measured by polysomnogram at baseline and 4-weeks |
| Secondary outcome measures | 1. Leg fluid volume measured by bio-electrical impendence 2. Overnight changes in leg fluid volume, thoracic fluid volume, neck circumference and neck fluid volume measured by bio-electrical impendence 3. Upper-airway cross-sectional area measured by acoustic pharyngometry |
| Overall study start date | 17/09/2014 |
| Completion date | 01/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 44 |
| Total final enrolment | 34 |
| Key inclusion criteria | Men and women 18-80 yrs of age with coronary artery disease (defined as a documented myocardial infarction, coronary bypass surgery or coronary angioplasty and/or stenting) and obstructive or central sleep apnea (AHI greater than 15 events/hr) |
| Key exclusion criteria | 1. Angina 2. Use of diuretics 3. Adeno-tonsillar hypertrophy 4. Inability to walk due to orthopedic or musculoskeletal problems 5. Previously treated OSA 6. Patients exercising more than 150 minutes per week at moderate intensity |
| Date of first enrolment | 17/09/2014 |
| Date of final enrolment | 01/09/2015 |
Locations
Countries of recruitment
- Canada
Study participating centre
M5G 1X8
Canada
Sponsor information
Government
160 Elgin Street
9th Floor
Ottawa
K1A 0W9
Canada
| Website | http://www.cihr-irsc.gc.ca/e/193.html |
|---|---|
"ROR" |
https://ror.org/01gavpb45 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2016 | 15/10/2020 | Yes | No |
| Results article | results | 15/01/2020 | 15/10/2020 | Yes | No |
Editorial Notes
15/10/2020: Publication references and total final enrolment number added.
