Telehealth Lifestyle and Exercise for COPD and OSA

(FOCuSEd Trial)

Recruiting at 4 trial locations

Overseen By Brianna Moss

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Institute for Biomedical and Clinical Research

Must not be taking: Weight loss medications

Disqualifiers: Severe illness, Bulimia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a telehealth program designed to improve the quality of life for people with COPD (a lung condition causing breathing difficulties) and OSA (a disorder that stops breathing during sleep). Participants will be divided into two groups: one will receive a special telehealth lifestyle program called the FOCuSEd Integrated Intervention, while the other will receive enhanced usual care, including referrals to weight loss and pulmonary rehab programs. The trial focuses on improving life quality, sleep, and health in individuals who are overweight or obese and have breathing issues. Those with both COPD and OSA, a history of smoking, and shortness of breath might be suitable for the trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance care for individuals with breathing issues.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on prescription weight loss medication, you must not have taken it in the last 3 months to be eligible.

What prior data suggests that this telehealth intervention is safe for patients with COPD and OSA?

Research has shown that telehealth treatments, such as the FOCuSEd Integrated Intervention, are generally safe for people with COPD and OSA. Studies have not identified any major problems associated with using telehealth to manage these conditions. This suggests that the telehealth method, which includes lifestyle changes and breathing exercises, is usually well-received. Participants can feel confident that current evidence supports the safety of this type of treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FOCuSEd Integrated Intervention because it combines a self-directed lifestyle program with supervised pulmonary rehabilitation, all delivered via telehealth. This approach is unique because it allows patients with COPD and OSA to manage their conditions from home, potentially increasing accessibility and convenience compared to traditional in-person sessions. Additionally, this method integrates lifestyle changes with medical intervention, offering a comprehensive strategy that targets both respiratory health and overall wellness. This could lead to better adherence and outcomes for patients, making it an innovative step forward in managing these chronic conditions.

What evidence suggests that this trial's treatments could be effective for COPD and OSA?

Research has shown that telehealth can improve the well-being of people with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). Studies indicate that lifestyle changes and exercise through telehealth enhance physical health, reflected in better quality of life scores. Participants in past research experienced fewer COPD flare-ups and improved sleep. In this trial, participants randomized to the FOCuSEd Integrated Intervention will receive a telehealth-delivered program focusing on self-guided lifestyle changes and supervised exercise, which has shown promise in managing symptoms of both conditions. These findings support the potential effectiveness of the FOCuSEd Integrated Intervention for individuals with COPD and OSA. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for overweight and obese patients with both COPD (Chronic Obstructive Pulmonary Disease) and OSA (Obstructive Sleep Apnea), receiving care at selected VA medical centers. Participants should be eligible for primary care services, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I experience shortness of breath when moving.

I have been diagnosed with obstructive sleep apnea.

I have COPD confirmed by a specific lung function test.

Exclusion Criteria

Active enrollment in pulmonary rehabilitation

Participation in other intervention studies

I have lost or gained more than 15 lbs in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation

3 months

Regular virtual visits

Post-core period

Participants continue to have as-needed access to the lifestyle coach

9 months

As-needed virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Virtual visits at 3 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• FOCuSEd Integrated Intervention

Trial Overview The study tests a telehealth intervention against 'enhanced' usual care in improving quality of life for those with COPD and OSA. The intervention includes a lifestyle program, supervised pulmonary rehab, and potential weight management medications. Usual care prompts referrals to existing programs.

How Is the Trial Designed?

Group I: FOCuSEd Intervention Active Control 1 Intervention

Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation.

Group II: Usual Care- Enhanced Active Control 1 Intervention

For participants in the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs.

Who Is Running the Clinical Trial?

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

Trials

55

Recruited

13,700+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

After a 2-year telerehabilitation program for COPD, physical activity levels significantly decreased in the following year, dropping from an average of 3,806 steps per day to 2,817 steps per day among nine participants.

Despite the decline in physical activity, other health outcomes such as quality of life, anxiety, and depression remained stable, suggesting that unsupervised home exercise alone may not be sufficient to sustain physical activity levels post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Physical activity and Benefits Maintained After Long-Term Telerehabilitation in COPD? Hoaas, H., Morseth, B., Holland, AE., et al.[2020]

A Delphi study involving 73 participants, including people with COPD and experts, identified 81 important items related to improving physical activity, sedentary behavior, and sleep, emphasizing the need for a multifactorial approach to behavior change.

Key themes included symptom management, targeting behavioral factors, and adapting social and physical environments, suggesting that addressing these areas could lead to effective, long-term interventions for individuals with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving physical activity, sedentary behaviour and sleep in COPD: perspectives of people with COPD and experts via a Delphi approach. Lewthwaite, H., Effing, TW., Lenferink, A., et al.[2022]

Both traditional exercise therapy (TET) and a behavioral lifestyle activity program (LAP) effectively increased moderate physical activity levels in COPD patients over a 12-month period, with no significant differences between the two approaches.

The study involved 176 COPD patients and assessed their physical activity levels at multiple time points, showing that both interventions led to similar improvements in activity levels, indicating that either program can be beneficial for enhancing physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lifestyle activity intervention in patients with chronic obstructive pulmonary disease. Berry, MJ., Rejeski, WJ., Miller, ME., et al.[2021]

Home-based exercise therapy using advanced telehealth technology (ATT-ET) significantly improves exercise capacity, quality of life, and functional dyspnoea in people with chronic obstructive pulmonary disease (COPD) compared to no exercise therapy, based on a systematic review of 15 trials with 1,522 participants.

ATT-ET shows similar or better effects on quality of life and functional dyspnoea compared to both in/outpatient exercise therapy and home-based exercise therapy without telehealth, indicating its effectiveness as a viable alternative for managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced telehealth technology improves home-based exercise therapy for people with stable chronic obstructive pulmonary disease: a systematic review. Bonnevie, T., Smondack, P., Elkins, M., et al.[2022]

The study found that telephone health-mentoring for home-based walking (tele-rehab) did not improve exercise capacity in people with COPD compared to usual care, indicating that this approach may not be effective for increasing physical activity levels.

Supervised exercise during pulmonary rehabilitation (PR) was essential for improving physical capacity, as participants who attended these sessions showed some improvement, highlighting the importance of structured exercise in managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of telephone-mentoring with home-based walking preceding rehabilitation in COPD. Cameron-Tucker, HL., Wood-Baker, R., Joseph, L., et al.[2018]

Telehealthcare significantly improves physical activity levels in patients with chronic obstructive pulmonary disease (COPD), with an average increase of 64.7 minutes compared to standard care, based on a systematic review of 9 studies involving 982 patients.

However, telehealthcare did not show significant differences in physical capacity or dyspnea levels, indicating that while it can enhance activity, it may not directly improve other aspects of COPD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. Lundell, S., Holmner, Å., Rehn, B., et al.[2022]

The 12-week telecoaching intervention for physical activity in COPD patients was well accepted, with 89.3% of participants enjoying the program, indicating high feasibility from both patient and coach perspectives.

While the step counter was used effectively, the smartphone app saw decreased usage over time, and patients needing more contact time experienced less improvement in physical activity, suggesting that tailored support may be necessary for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Based Physical Activity Telecoaching in Chronic Obstructive Pulmonary Disease: Mixed-Methods Study on Patient Experiences and Lessons for Implementation. Loeckx, M., Rabinovich, RA., Demeyer, H., et al.[2023]

A patient registry was successfully used to recruit a representative sample of 5582 outpatients with COPD, achieving a participation rate of 35.1% over 30 months for a trial focused on increasing physical activity.

After a 6-week education period, 305 patients were randomized into two groups, showing no significant differences in demographics or health status, indicating that the recruitment method effectively captured a diverse and comparable population for the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): results of recruitment and baseline patient characteristics. Russo, R., Coultas, D., Ashmore, J., et al.[2023]

The 'Active for Life with COPD' intervention, which included walking and functional training over 10 weeks, was found to be feasible and acceptable for participants, with 26 out of 36 subjects completing the program.

Participants reported an increase in light physical activity, with an average increase of 36 minutes of standing/stepping per day, and they maintained a gain of 21 minutes at a two-month follow-up, suggesting potential for long-term physical activity maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of active for life with COPD, an intervention to increase light physical activity in people with COPD. Larson, JL., Webster, KE.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06390345?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(sf12))&rank=10

Functional Improvement in OSA and COPD With a ... The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will ...

2. ctv.veeva.com ctv.veeva.com/study/functional-improvement-in-osa-and-copd-with-a-telehealth-lifestyle-and-exercise-intervention

Functional Improvement in OSA and COPD With a Telehealth ... Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention (FOCuSEd). Seattle Institute for Biomedical and ...

3. withpower.com withpower.com/trial/phase-lung-diseases-obstructive-4-2024-e44a6?condition=copd&hasNoPlacebo=false&overallStatus=Recruiting

Telehealth Lifestyle and Exercise for COPD and OSA What data supports the effectiveness of the FOCuSEd Integrated Intervention treatment for COPD and OSA? Research shows that using telehealth technology to ...

4. pcori.org pcori.org/research-results/2023/functional-improvement-obstructive-sleep-apnea-and-chronic-obstructive-pulmonary-disease-telehealth-lifestyle-and-exercise-intervention-focused

Functional improvement in Obstructive Sleep Apnea and ... Functional improvement in Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease with a Telehealth LifeStyle and Exercise Intervention (FOCuSEd)

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06382883

Lifestyle and Physical Activity as Part Of Obstructive Sleep ... The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3384362/

Home Telehealth for Patients With Chronic Obstructive ... The objective of this analysis was to conduct an evidence-based assessment of home telehealth technologies for patients with chronic obstructive pulmonary ...