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

NCT ID: NCT03086850

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2025-11-03

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.

Conditions

Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pedometer

Standard recommendations on healthy habits and lifestyle plus daily recording of steeps with a pedometer

Group Type: EXPERIMENTAL

Promotion of daily physical activity with a pedometer

Intervention Type: BEHAVIORAL

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

Conventional treatment

Intervention Type: OTHER

Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle.

Conventional management

Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle.

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle.

Interventions

Promotion of daily physical activity with a pedometer

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

Intervention Type: BEHAVIORAL

Conventional treatment

Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Francisco Garcia-Rio

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Francisco Garcia-Rio

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Francisco Garcia-Rio, MD

Role: CONTACT

fgr01m@gmail.com

+34914269802

Facility Contacts

Francisco Garcia-Rio, MD

Role: primary

fgr01m@gmail.com

+34914269802

Other Identifiers

HULP-2613

Identifier Type: -

Identifier Source: org_study_id