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

NCT03086850 | Unknown

• 1 other identifier: HULP-2613
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Nocturnal oxyhemoglobin saturation

  12 months

• Physical activity level

  12 months

• Baseline determinants of physical activity

  12 months

• Body composition

  12 months

• Diurnal sleepiness

  12 months

Study Arms (2)

Pedometer

EXPERIMENTAL

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

Behavioral: Promotion of daily physical activity with a pedometer; Other: Conventional treatment

Conventional management

ACTIVE COMPARATOR

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

Other: Conventional treatment

Interventions

Promotion of daily physical activity with a pedometer 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

Pedometer

Conventional treatment OTHER

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

Conventional management; Pedometer

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Francisco Garcia-Rio

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Francisco Garcia-Rio, MD

CONTACT

+34914269802; fgr01m@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: April 3, 2025
• Primary Completion: April 3, 2025
• Study Completion: November 3, 2025
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)