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

NCT03997877 | Terminated

• 1 other identifier: SAH-2014
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Hypopnea Syndrome; Physical Activity

Keywords

sleep apnea syndrome; physical activity; mediterranean diet; metabolism; impact on sleep

Outcome Measures

Primary Outcomes (1)

• Change of the variable AHI measured by polygraphy

  Decrease in the value of the AHI after a physical exercise program

  six months

Secondary Outcomes (6)

• Changes in glucose metabolism after a physical exercise program.

  six months

• Changes on the lipid profile after a physical activity program

  six months

• Change in systolic and diastolic blood pressure values after a physical activity program.

  six months

• Change on body weight after a physical activity program

  six months

• Modification of daytime sleepiness after a physical activity program.

  six months

Study Arms (2)

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.

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.

Other: Physical activity

Interventions

Physical activity OTHER

Increase physical activity Balanced diet

Also known as: Mediterranean diet

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Motor Activity; Sleep Apnea Syndromes

Interventions

Exercise; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nuria Feu, MD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 25, 2019
• Study Start: November 13, 2015
• Primary Completion: June 30, 2017
• Study Completion: December 15, 2017
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available after the end of the study until one year the article publication.
• Access Criteria: To obtain the data, a proposal must be sent to uicec@imibic.org. To gain access, data requestors will need to sign a data access agreement.

Locations

ES (1)