Sleep Apnea Hypopnea SyndromeSAH-2014NCT03997877
Effect of an Aerobic Exercise Program in Patients With Moderate-severe Sleep Apnea
A study testing Physical activity in people with Sleep Apnea Hypopnea Syndrome and Physical Activity, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
In this paper, it is postulated that in sedentary patients with moderate-severe sleep apnea diagnosed by a sleep test, an increase in physical activity stimulated by the use of a pedometer during a period of 6 months can reduce the severity of OSAS by decreasing the number of respiratory events during sleep and when… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Apnea Hypopnea Syndrome, Physical Activity
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSpain
- Study dates
- 13 Nov 2015to 15 Dec 2017
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Low physical activity (total duration <60 minutes / week or a physical activity index calculated using the YPAS scale <51).
- An AHI> 15 and <30 / hour or AHI> 30 and rejection of CPAP.
- Signature of the informed consent form.
Who cannot join
- Suspicion or knowledge of a chronic disease that prevents a physical exercise program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial on the Effect of an Aerobic Exercise Program in Patients With Moderate-severe Sleep Apnea
In this paper, it is postulated that in sedentary patients with moderate-severe sleep apnea diagnosed by a sleep test, an increase in physical activity stimulated by the use of a pedometer during a period of 6 months can reduce the severity of OSAS by decreasing the number of respiratory events during sleep and when controlling for vascular risk factors.
Read the detailed description
It is postulated that in sedentary patients with moderate to severe sleep apnea, an increase in physical activity can reduce the severity of OSAS.
Our main objective was to determine the effectiveness of a physical exercise program to reduce the number of respiratory disorders during sleep (AHI) in patients with moderate-severe OSAS. The primary outcome variable will be the decrease in the AHI at least 50% of its baseline value.
Secondary objectives were:
- To evaluate the impact of a physical activity program on glucose metabolism (glycemia, insulinemia, glycosylated hemoglobin, HOMA index).
- Determine the effect of the physical activity program on the lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides, apolipoproteins A1 and B).
- Assess the role of a physical activity program on the systolic and diastolic blood pressure.
- Determine the effect of a physical activity program on body weight (BMI).
- To analyze the effect of a physical activity program on the perception of the impact of sleep on daily life (FOSQ questionnaire).
It is a controlled, randomized and parallel group clinical trial with an allocation ratio of 1: 1 For randomization, a table of random numbers with sampling module of the Epidat 3.1 program will be prepared by a statistician who does not participate in the study.
The ratio of subjects assigned to each group will be 1: 1. The random numbers will be kept in closed envelopes.
The staff of the Sleep Unit will be responsible for explaining the result of the polygraphy and following the patient, but in no case will participate in the measurement of the results.
All patients will be informed about the nature of the clinical trial, but without exposing the hypothesis to the patient. There will be no differences in the patient's follow-up because it will be performed by the same physician.
Special emphasis will be made so that the medical and nursing staff does not try to obtain or offer specific information that may indicate to which treatment arm the patient was assigned.
Once the patient is randomized and assigned to an arm of the study, those assigned to the intervention group will be sent to the physiotherapist to explain and initiate the exercise program while the control group will be informed to maintain their usual physical activity.
All subjects will be recommended to maintain a stable sleep habit, to sleep at least 7 hours at night, avoid the intake of relaxing medication during the evening and maintain the nutritional pattern recommended by the American Heart Association, this is 35% of calories in the form of fat (22% monounsaturated fat, 6% polyunsaturated fat, 7% saturated fat) 15% proteins and 50% carbohydrates. These recommendations and an explanatory leaflet based on the pyramid model of the mediterranean diet will be delivered to the two groups. The monitoring of the diet will be supervised by filling in the questionnaire of the Quality Index of the Mediterranean Diet (KIDMED) by the subjects in the initial visit, the third month and the sixth month. In the initial visit, the type of diet will be evaluated and all patients will be advised to follow a mediterranean diet as a general treatment measure. If the Kidmed index is ≤ 3, it will be re-educated to perform a Mediterranean diet and if the index is ≥ 7 you will be advised to maintain the diet during the following months.
- Conditions
- Sleep Apnea Hypopnea Syndrome, Physical Activity
- Being tested
- Physical activity
- Keywords
- sleep apnea syndrome, physical activity, mediterranean diet, metabolism, impact on sleep
- Medical subject headings
- Sleep Apnea, Obstructive, Motor Activity, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Also called Mediterranean diet
Increase physical activity Balanced diet
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The usual physical activity valued by the YPAS questionnaire (Yale Physical Activity Survey) will be maintained. The questionnaire allows to calculate the time in physical activity expressed in hours / week, the energy expenditure expressed in MET-h / week and the summary index of physical activity that takes into account the frequency and duration of physical activity and oscillates from 0 to 137. A value below 51 identifies sedentary patients. Daily physical activity is controlled through a pedometer that measures the distance traveled daily by the patient and recorded in a walking book.
The therapeutic control will be carried out by telephone call at the second and fourth month of treatment and a face-to-face clinical control at 3 and 6 months. Receives: Other: Physical activity |
| Intervention | Experimental | It is intended that the exercise program have a duration of 6 months and its realization does not suppose an excessive consumption of resources. Therefore, it must have a series of characteristics: low supervision and easily realizable by all patients, which implies flexibility in the schedule and without the need for instruments or special facilities. In this sense the walk is adjusted to these assumptions and the goal of 10.000 steps / day can encourage compliance.
The subjects assigned to the intervention group will be supervised and trained by a physiotherapist who will explain the training program and resolve the doubts raised by the patient.
Daily physical activity is controlled through a pedometer that measures the distance traveled daily by the patient and recorded in a walking book.
The therapeutic control will be carried out by telephone call at the second and fourth month of treatment and a face-to-face clinical control at 3 and 6 months. Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the variable AHI measured by polygraphy
Decrease in the value of the AHI after a physical exercise program
Measured: six months
Secondary outcomes (6)
Changes in glucose metabolism after a physical exercise program.
Decrease in the value of glycemia, insulinemia, glycosylated hemoglobin and HOMA index
Measured: six months
Changes on the lipid profile after a physical activity program
Decrease in the value of total cholesterol, HDL-C, LDL, triglycerides, apolipoprotein A-1 and B
Measured: six months
Change in systolic and diastolic blood pressure values after a physical activity program.
The value of the blood pressure will be an average value of three blood pressure determinations
Measured: six months
Change on body weight after a physical activity program
Value of the body mass index
Measured: six months
Modification of daytime sleepiness after a physical activity program.
Change in daytime sleepiness measured by the Epworth Sleepiness Scale. The Epworth Scale includes 8 questions about the possibility of falling asleep in various situations, such as reading, watching television, talking, driving. Each question has four possible answers, with values between 0 and 3. The total score is obtained by adding the values of each answer option; the minimum value is zero (no sleepiness) and the maximum is 24, which means excessive sleepiness.
Measured: six months
Change in the impact of sleep on daily living after a physical activity program
Change in the impact of daytime sleepiness on activities of daily living after a physical activity program by the Functional Outcomes of Sleep Questionnaire. The FOSQ consists of 30 questions divided into 5 subscales: general productivity, social activity, activity level, surveillance and sexual relations and intimacy. Each element has 4 possible answers: "without difficulty", "small difficulty", "moderate difficulty" and "a lot of difficulty". In some items, there is an alternative response if that the activity is not performed for other reasons unrelated to sleepiness. The scores of each one of the dimensions are obtained by means of the average of the items that form it. Items that have not been answered are not included. The score of each dimension has a minimum value of 0 (maximum functional impact) and a maximum value of 24 (no impact). The general score is obtained by adding the scores of each of the 5 dimensions and has a value between 0 and 120.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start13 Nov 2015
- Primary completion30 Jun 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Hypopnea SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuria Feu, MD, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997877
- Sponsor's protocol ID
- SAH-2014
- Acronym
- SAH-2014
- Status last verified
- Jul 2019
- First submitted
- 19 Jun 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual data will be available after deidenttification (text, tables, figures and appendices) to those researchers who provide a methodologically sound proposal and for meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Effect of an Aerobic Exercise Program in Patients With Moderate-severe Sleep Apnea
- ClinicalTrials.gov ID
- NCT03997877
- Acronym / sponsor ID
- SAH-2014 / SAH-2014
- Conditions
- Sleep Apnea Hypopnea Syndrome, Physical Activity
- Keywords
- sleep apnea syndrome, physical activity, mediterranean diet, metabolism, impact on sleep
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 25 Jun 2019 (actual)
- 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.
In this paper, it is postulated that in sedentary patients with moderate-severe sleep apnea diagnosed by a sleep test, an increase in physical activity stimulated by the use of a pedometer during a period of 6 months can reduce the severity of OSAS by decreasing the number of respiratory events during sleep and when controlling for vascular risk factors.
Detailed description
It is postulated that in sedentary patients with moderate to severe sleep apnea, an increase in physical activity can reduce the severity of OSAS.
Our main objective was to determine the effectiveness of a physical exercise program to reduce the number of respiratory disorders during sleep (AHI) in patients with moderate-severe OSAS. The primary outcome variable will be the decrease in the AHI at least 50% of its baseline value.
Secondary objectives were:
- To evaluate the impact of a physical activity program on glucose metabolism (glycemia, insulinemia, glycosylated hemoglobin, HOMA index).
- Determine the effect of the physical activity program on the lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides, apolipoproteins A1 and B).
- Assess the role of a physical activity program on the systolic and diastolic blood pressure.
- Determine the effect of a physical activity program on body weight (BMI).
- To analyze the effect of a physical activity program on the perception of the impact of sleep on daily life (FOSQ questionnaire).
It is a controlled, randomized and parallel group clinical trial with an allocation ratio of 1: 1 For randomization, a table of random numbers with sampling module of the Epidat 3.1 program will be prepared by a statistician who does not participate in the study.
The ratio of subjects assigned to each group will be 1: 1. The random numbers will be kept in closed envelopes.
The staff of the Sleep Unit will be responsible for explaining the result of the polygraphy and following the patient, but in no case will participate in the measurement of the results.
All patients will be informed about the nature of the clinical trial, but without exposing the hypothesis to the patient. There will be no differences in the patient's follow-up because it will be performed by the same physician.
Special emphasis will be made so that the medical and nursing staff does not try to obtain or offer specific information that may indicate to which treatment arm the patient was assigned.
Once the patient is randomized and assigned to an arm of the study, those assigned to the intervention group will be sent to the physiotherapist to explain and initiate the exercise program while the control group will be informed to maintain their usual physical activity.
All subjects will be recommended to maintain a stable sleep habit, to sleep at least 7 hours at night, avoid the intake of relaxing medication during the evening and maintain the nutritional pattern recommended by the American Heart Association, this is 35% of calories in the form of fat (22% monounsaturated fat, 6% polyunsaturated fat, 7% saturated fat) 15% proteins and 50% carbohydrates. These recommendations and an explanatory leaflet based on the pyramid model of the mediterranean diet will be delivered to the two groups. The monitoring of the diet will be supervised by filling in the questionnaire of the Quality Index of the Mediterranean Diet (KIDMED) by the subjects in the initial visit, the third month and the sixth month. In the initial visit, the type of diet will be evaluated and all patients will be advised to follow a mediterranean diet as a general treatment measure. If the Kidmed index is ≤ 3, it will be re-educated to perform a Mediterranean diet and if the index is ≥ 7 you will be advised to maintain the diet during the following months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Physical activityThe usual physical activity valued by the YPAS questionnaire (Yale Physical Activity Survey) will be maintained. The questionnaire allows to calculate the time in physical activity expressed in hours / week, the energy expenditure expressed in MET-h / week and the summary index of physical activity that takes into account the frequency and duration of physical activity and oscillates from 0 to 137. A value below 51 identifies sedentary patients. Daily physical activity is controlled through a pedometer that measures the distance traveled daily by the patient and recorded in a walking book. The therapeutic control will be carried out by telephone call at the second and fourth month of treatment and a face-to-face clinical control at 3 and 6 months. |
| Intervention | Experimental | Other: Physical activityIt is intended that the exercise program have a duration of 6 months and its realization does not suppose an excessive consumption of resources. Therefore, it must have a series of characteristics: low supervision and easily realizable by all patients, which implies flexibility in the schedule and without the need for instruments or special facilities. In this sense the walk is adjusted to these assumptions and the goal of 10.000 steps / day can encourage compliance. The subjects assigned to the intervention group will be supervised and trained by a physiotherapist who will explain the training program and resolve the doubts raised by the patient. Daily physical activity is controlled through a pedometer that measures the distance traveled daily by the patient and recorded in a walking book. The therapeutic control will be carried out by telephone call at the second and fourth month of treatment and a face-to-face clinical control at 3 and 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years.
- Low physical activity (total duration <60 minutes / week or a physical activity index calculated using the YPAS scale <51).
- An AHI> 15 and <30 / hour or AHI> 30 and rejection of CPAP.
- Signature of the informed consent form.
Key exclusion criteria (1 listed)
- Suspicion or knowledge of a chronic disease that prevents a physical exercise program.
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 |
|---|---|---|
| Physical activityAlso: Mediterranean dietIncrease physical activity Balanced diet | Other | Control, Intervention |
Primary outcome
Change of the variable AHI measured by polygraphy
Time frame: six months
Decrease in the value of the AHI after a physical exercise program
6 secondary outcomes
Changes in glucose metabolism after a physical exercise program.
Time frame: six months
Changes on the lipid profile after a physical activity program
Time frame: six months
Change in systolic and diastolic blood pressure values after a physical activity program.
Time frame: six months
Change on body weight after a physical activity program
Time frame: six months
Modification of daytime sleepiness after a physical activity program.
Time frame: six months
Change in the impact of sleep on daily living after a physical activity program
Time frame: six months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: Yes. The individual data will be available after deidenttification (text, tables, figures and appendices) to those researchers who provide a methodologically sound proposal and for meta-analysis.
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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.
Nuria Feu, MD principal investigator
Hospital General Universitario Reina Sofía de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Sleep Apnea Hypopnea Syndrome and Physical Activity, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 10 Jul 2019. 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 Spain. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Change of the variable AHI measured by polygraphy (time frame: six months). 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 10 Jul 2019.