Long-term Effect of the Physical Activity Promotion on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Main objective: To assess the effect of the daily physical activity promotion with a pedometer during 12 months on the apnea-hypopnea index (AHI) in patients with mild to moderate obstructive sleep apnea (OSA). Study patients. Subjects 30-80 years old with diagnosis of mild-moderate OSA (AHI: 5-30 and predominance of obstructive events [>80%)]. Design. Randomized, parallel and open-label clinical trial, controlled with conventional treatment. Intervention: Patients will be randomized (1:1) to control group [treatment and follow-up according to conventional clinical practice] or intervention group [in addition to conventional treatment and follow-up, the patients will receive a pedometer to measure the number of steps walked daily. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol (<6000 steps/day: increase by 3000 steps/day; 6000 - 10000 steps/day: reach 10000 steps/day; and > 10000 steps/day: maintain or increase steps). Measurements. At , 12, 24 and 52 weeks of randomization, the following determinations will be made: anthropometric characteristics; clinical evaluation (smoking history, sleep symptoms, comorbidities, current medication); questionnaires (ESS, FOSQ, SF-12, EuroQoL and iPAZ); heart rate and blood pressure; analytical determinations (HbA1c, HOMA index, cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, homocysteine, NT-proBNP and hsCRP); plasmatic biomarkers (8-isoprostane, IL1beta, IL6, IL8 and TNFalpha); and evaluation of daily physical activity using an accelerometer.

Official Title
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Randomized, Parallel and Controled Clinical Trial to Assess the Effect of the Physical Activity Promotion During 12 Months on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea

Conditions
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Sleep Apnea

Intervention / Treatment
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* Behavioral: Promotion of daily physical activity with a pedometer
* Other: Conventional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 30 to 80 years Diagnosis of mild-moderate obstructive sleep apnea [apnea-hypopnea index 5-30 h-1] by polysomnography or respiratory polygraphy Predominance of obstructive events (> 80%) Signature of informed consent Exclusion Criteria: Previous diagnosis of chronic obstructive pulmonary disease, asthma, diffuse interstitial lung disease or chest wall disease. Evidence of central apneas, hypoventilation syndrome or respiratory failure Previous diagnosis of refractory arterial hypertension, congestive heart failure, ischemic heart disease or cerebro-vascular disease. Neurological or osteoarticular limitation that prevents ambulation. Professional drivers or occupational risk or respiratory Previous treatment with CPAP Participation in another clinical trial in the 30 days prior to randomization.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pedometer<br>Standard recommendations on healthy habits and lifestyle plus daily recording of steeps with a pedometer | Behavioral: Promotion of daily physical activity with a pedometer<br>* Patients will receive an ONwalk 100 pedometer (GEONAUTE, France) and will be instructed how to use it. They will be encouraged to be more active by using the pedometer to measure the number of steps walked daily and to record this in a diary, together with any information related to their clinical condition. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol: <6000 steps/day: increase by 3000 steps/day 6000 - 10000 steps/day: reach 10000 steps/day > 10000 steps/day: maintain or increase steps<br>Other: Conventional treatment<br>* Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle.<br>|
| Active Comparator: Conventional management<br>Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle. | Other: Conventional treatment<br>* Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea index | To compare the apnea-hypopnea index of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal oxyhemoglobin saturation | To compare the nocturnal oxyhemoglobin saturation of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer | 12 months | 
| Physical activity level | To compare the physical activity level of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer | 12 months | 
| Baseline determinants of physical activity | To relate the baseline physical activity performed by patients with mild-moderate sleep apnea with their sleep parameters | 12 months | 
| Body composition | To compare the fat free mass index of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer | 12 months | 
| Diurnal sleepiness | To compare the Epworth sleepiness scale of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer | 12 months | 
| Functional impact | To compare the total score of the Functional Outcomes of Sleep Questionnaire of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer | 12 months | 
| Systematic Coronary Risk Evaluation | To compare the Systematic Coronary Risk Evaluation of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer | 12 months | 
| Insulin sensitivity | To compare the HOMA index of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer | 12 months | 
| Oxidative stress | To compare the plasmatic 8-isoprostane levels of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer | 12 months | 
| Systemic inflammation | To compare the plasmatic levels of IL-1beta, IL6, IL8 and TNF-alpha of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer | 12 months |