Clinical trial NCT03086850: Long-term Effect of the Physical Activity Promotion on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 144
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Apnea-hypopnea index
timeFrame: 12 months
Secondary outcomes:
measure: Nocturnal oxyhemoglobin saturation
timeFrame: 12 months
measure: Physical activity level
timeFrame: 12 months
measure: Baseline determinants of physical activity
timeFrame: 12 months
measure: Body composition
timeFrame: 12 months
measure: Diurnal sleepiness
timeFrame: 12 months
measure: Functional impact
timeFrame: 12 months
measure: Systematic Coronary Risk Evaluation
timeFrame: 12 months
measure: Insulin sensitivity
timeFrame: 12 months
measure: Oxidative stress
timeFrame: 12 months
measure: Systemic inflammation
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Francisco Garcia-Rio
Study officials:
References: