Effect of an Aerobic Exercise Program in Patients With Moderate-severe Sleep Apnea

NCT ID: NCT03997877

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-13
• Study Completion Date: 2017-12-15

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.

Conditions

Sleep Apnea Hypopnea Syndrome; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

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.

Group Type: ACTIVE_COMPARATOR

Physical activity

Intervention Type: OTHER

Increase physical activity Balanced diet

Intervention

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.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: OTHER

Increase physical activity Balanced diet

Interventions

Physical activity

Increase physical activity Balanced diet

Intervention Type: OTHER

Other Intervention Names

Mediterranean diet

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nuria Feu, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Reina Sofía

Locations

Hospital Universitario Reina Sofía

Córdoba, , Spain

Countries

Spain

Other Identifiers

SAH-2014

Identifier Type: -

Identifier Source: org_study_id