Long-term Effect of the Physical Activity Promotion on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea
- Conditions
- Sleep Apnea
- Interventions
- Behavioral: Promotion of daily physical activity with a pedometerOther: Conventional treatment
- Registration Number
- NCT03086850
- Lead Sponsor
- Hospital Universitario La Paz
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pedometer Conventional treatment Standard recommendations on healthy habits and lifestyle plus daily recording of steeps with a pedometer Pedometer Promotion of daily physical activity with a pedometer Standard recommendations on healthy habits and lifestyle plus daily recording of steeps with a pedometer Conventional management Conventional treatment Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle.
- Primary Outcome Measures
Name Time Method Apnea-hypopnea index 12 months 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
- Secondary Outcome Measures
Name Time Method Insulin sensitivity 12 months 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
Nocturnal oxyhemoglobin saturation 12 months 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
Physical activity level 12 months 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
Baseline determinants of physical activity 12 months To relate the baseline physical activity performed by patients with mild-moderate sleep apnea with their sleep parameters
Body composition 12 months 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
Diurnal sleepiness 12 months 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
Functional impact 12 months 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
Systematic Coronary Risk Evaluation 12 months 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
Oxidative stress 12 months 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
Systemic inflammation 12 months 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
Trial Locations
- Locations (1)
Francisco Garcia-Rio
🇪🇸Madrid, Spain