Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention

{ "Telehealth Lifestyle and Exercise for COPD and OSA", "This study is testing a telehealth (remote healthcare) program called FOCuSEd Integrated Intervention for people with Chronic Obstructive Pulmonary Disease (COPD), Obstructive Sleep Apnea (OSA), and who are overweight or obese. The program focuses on healthy eating and 150 minutes of moderate exercise each week. It's being compared to \"Enhanced Usual Care,\" which includes referrals to the VA's MOVE! weight loss program and pulmonary rehabilitation. The study aims to see if the FOCuSEd Integrated Intervention improves your physical health, measured by a health survey after one year. You might be able to join if you have COPD, a history of smoking, diagnosed OSA, a BMI of 25 or higher, and experience shortness of breath. The study plans to enroll 400 participants.", "design": "This study will include 400 participants who will be randomly assigned to either the FOCuSEd Integrated Intervention or Enhanced Usual Care. This is an interventional study, meaning participants will receive specific treatments.", "commitments": "Participants in the intervention group will receive a telehealth-delivered lifestyle program and supervised pulmonary rehabilitation. Participants in the usual care group will be referred to MOVE! and pulmonary rehabilitation. The primary outcome will be measured at 1 year.", "compensation": "Not stated in the trial record.", "follow_up": "Your physical health will be assessed at 1 year after starting the intervention.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06390345

Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention

Recruiting
NAAges 18+InterventionalTreatment
Seattle Institute for Biomedical and Clinical Research
~400 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:FOCuSEd Integrated InterventionEnhanced Usual Care

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The SF-12 PCS
Measured over 1 year
Chronic Obstructive Pulmonary Disease
Obstructive Sleep Apnea
Overweight and Obesity
5 sites across 4 states
Washington2
Idaho1
Illinois1
Minnesota1

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Eligibility criteria

Inclusion

COPD: Defined by presence of airflow obstruction (FEV1/FVC \< 0.70) on post-bronchodilator spirometry
≥10 pack year history of tobacco use
Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)
BMI ≥ 25 kg/m2
Symptoms of dyspnea defined by MMRC score of ≥1

Exclusion

Self-report of weight change \>15 lbs. during prior 3 months
Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery.
Severe illness from any cause
Diagnosis of bulimia or history of purging behavior
Active enrollment in pulmonary rehabilitation
Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy \< 12 months. These include but may not be limited to: unstable cardiac arrhythmias, active or recent (within one month) myocardial infarction, active or recent (within one month) COPD exacerbation, angina not well-controlled with medication, significant musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program, and the need for supplemental oxygen ≥ 5 lpm at rest or with exertion.
Pregnant, lactating, or planning to become pregnant during the study period
Participation in other intervention studies.
Prisoner
Unable to complete surveys in English
  • The SF-12 PCS1 year

    The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.