Clinical trial NCT03997877: Effect of an Aerobic Exercise Program in Patients With Moderate-severe Sleep Apnea
Official title: Randomized Clinical Trial on the Effect of an Aerobic Exercise Program in Patients With Moderate-severe Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Apnea Hypopnea Syndrome
Physical Activity
Keywords: sleep apnea syndrome
physical activity
mediterranean diet
metabolism
impact on sleep
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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:

1. To evaluate the impact of a physical activity program on glucose metabolism (glycemia, insulinemia, glycosylated hemoglobin, HOMA index).
2. Determine the effect of the physical activity program on the lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides, apolipoproteins A1 and B).
3. Assess the role of a physical activity program on the systolic and diastolic blood pressure.
4. Determine the effect of a physical activity program on body weight (BMI).
5. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

- Suspicion or knowledge of a chronic disease that prevents a physical exercise program.

Primary outcomes:
measure: Change of the variable AHI measured by polygraphy
timeFrame: six months
Secondary outcomes:
measure: Changes in glucose metabolism after a physical exercise program.
timeFrame: six months
measure: Changes on the lipid profile after a physical activity program
timeFrame: six months
measure: Change in systolic and diastolic blood pressure values after a physical activity program.
timeFrame: six months
measure: Change on body weight after a physical activity program
timeFrame: six months
measure: Modification of daytime sleepiness after a physical activity program.
timeFrame: six months
measure: Change in the impact of sleep on daily living after a physical activity program
timeFrame: six months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
Study officials:
affiliation: Hospital Universitario Reina Sofía
name: Nuria Feu, MD
role: PRINCIPAL_INVESTIGATOR
References: