Interval Exercise for COPD and Sleep Apnea

Overseen By Tracy A Hicks

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cad, Orthopedic problems, Fall risk, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise can benefit individuals with both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), collectively known as Overlap Syndrome. The researchers aim to determine if a specific exercise plan can enhance daily activities, increase physical activity, and improve heart health for Veterans with this condition. Participants will either maintain their usual routine or engage in moderate exercise sessions three times a week for 12 weeks. Those with both COPD and OSA who are not currently involved in vigorous exercise are ideal candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of exercise for those with Overlap Syndrome.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise protocol is safe for individuals with COPD and sleep apnea?

Research shows that exercise can be safe and helpful for people with chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). Studies have found that high-intensity interval training (HIIT) improves lung function, increases exercise ability, and enhances quality of life for those with COPD. Another study found that moderate-intensity aerobic exercise benefits patients when combined with other treatments.

For people with OSA, aerobic exercise reduces symptoms like snoring and improves overall fitness. These findings suggest that exercise, such as the moderate-intensity interval training used in this trial, is well-tolerated and can lead to positive results for people with both COPD and OSA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using interval exercise for COPD and sleep apnea because it offers a non-drug approach to managing these conditions, which traditionally rely on medications, oxygen therapy, or CPAP machines. Most treatments focus on alleviating symptoms, but moderate intensity interval training aims to enhance overall physical conditioning and respiratory efficiency. This method might improve patients' quality of life by boosting cardiovascular fitness, which could lead to better breathing and reduced sleep apnea episodes. Additionally, exercise as a treatment is accessible and potentially lowers healthcare costs, making it an appealing option for both patients and healthcare systems.

What evidence suggests that this exercise might be an effective treatment for Overlap Syndrome?

Research has shown that exercise, especially interval training, benefits people with both COPD and sleep apnea. Studies have found that high-intensity interval training can improve lung function and exercise capacity in those with COPD. This type of exercise also links to a better quality of life. Another study found that regular physical activity might lower the risk of sleep problems in people with COPD. Additionally, exercise can help reduce daytime sleepiness, common in sleep apnea. In this trial, participants in the exercise arm will undergo moderate-intensity interval training, which could improve health in patients with both COPD and sleep apnea. ^{2 3 4 5 6}

Who Is on the Research Team?

Madalina Macrea, MD PhD

Principal Investigator

Salem VA Medical Center, Salem, VA

Are You a Good Fit for This Trial?

This trial is for veterans with Overlap Syndrome, which means they have both COPD and OSA. They must show cognitive function with a MoCA score over 20. Those who already do structured exercise, need daytime oxygen, have recent heart issues or hospitalization, orthopedic problems limiting walking, or a high fall risk cannot join.

Inclusion Criteria

I have been diagnosed with COPD and OSA based on specific lung and sleep tests.

Montreal Cognitive Assessment (MoCA) >20

Exclusion Criteria

I have a history of heart issues like bypass surgery or heart attack.

I have joint pain that makes it hard for me to walk.

I use oxygen at home during the day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo moderate intensity interval training (MIIT) or maintain routine activity level for 12 weeks

12 weeks

3 times weekly for exercise group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study aims to develop an exercise program specifically for veterans with Overlap Syndrome to prevent early functional decline. It will measure the impact of interval exercise on participation in life situations, physical activity levels, and cardiovascular health.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 1 Intervention

The Experimental Design is a randomized trial of Moderate intensity interval training (5-minute intervals at 50% VO2peak 3 times weekly for 12 weeks) in Veterans with COPD and OSA compared with standard of care controls

Group II: Usual Care Active Control 1 Intervention

Participants in the control group will be instructed to maintain their routine activity level for 12 weeks

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A systematic review and meta-analysis of studies on exercise training in patients with chronic obstructive pulmonary disease (COPD) found a small but significant increase in daily physical activity after at least 4 weeks of supervised exercise training.

Despite the overall positive effect, the quality of the studies was variable, with no randomized controlled trials meeting the criteria, indicating that while exercise can help improve physical activity in COPD patients, more rigorous research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does exercise training change physical activity in people with COPD? A systematic review and meta-analysis. Cindy Ng, LW., Mackney, J., Jenkins, S., et al.[2022]

A 2-week intervention involving regular phone calls successfully increased daily activity levels in 21 patients with stable severe COPD, leading to significant improvements in exercise capacity as measured by the 6-minute walking distance (6MWD).

The increase in activity was associated with enhanced quality of life scores, demonstrating that motivational support can effectively boost both physical activity and overall well-being in patients with severe COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention by phone calls raises domiciliary activity and exercise capacity in patients with severe COPD. Wewel, AR., Gellermann, I., Schwertfeger, I., et al.[2007]

This study aims to compare the effectiveness of interval exercise versus high-intensity continuous exercise in improving health-related quality of life (HRQL) and exercise capacity in patients with moderate to severe COPD, with 52 patients per group planned for a total of 12-15 exercise sessions during inpatient rehabilitation.

Interval exercise may offer better exercise tolerance for COPD patients who struggle with continuous high-intensity exercise due to symptoms like dyspnoea and leg fatigue, potentially making it a more feasible option for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interval exercise versus continuous exercise in patients with moderate to severe chronic obstructive pulmonary disease--study protocol for a randomised controlled trial [ISRCTN11611768]. Puhan, MA., Büsching, G., VanOort, E., et al.[2018]

A systematic review of 15 studies involving 761 subjects found that interventions aimed at increasing physical activity in people with COPD showed promise, with 8 out of 15 studies reporting statistically significant increases in activity levels.

The quality of the studies varied, with exercise-only interventions rated highest, and while some interventions were effective, the increases in physical activity were often modest and not always clinically meaningful, indicating a need for further research to identify more effective strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to increase physical activity in people with COPD: systematic review. Larson, JL., Vos, CM., Fernandez, D.[2018]

General exercise training significantly improves quality of life in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) compared to standard care without pulmonary rehabilitation.

After a COPD exacerbation, exercise training can reduce the risk of hospitalization by at least 50% in the following months, and the overall harm-benefit balance of exercise training in COPD appears favorable based on available data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COPD: benefits of exercise training. [2016]

A systematic review of 8 randomized controlled trials involving 388 patients with COPD found no significant differences in exercise capacity or health-related quality of life between interval and continuous training methods.

Both training modalities showed similar effects on peak oxygen uptake, peak power, and 6-minute walk test distance, suggesting that interval training can be a viable alternative to continuous training for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review. Beauchamp, MK., Nonoyama, M., Goldstein, RS., et al.[2022]

In a study of 62 patients with obstructive sleep apnea (OSA), treatment with continuous positive airway pressure (CPAP) significantly improved both sleep quality and physical activity levels over 3 to 7 months, with participants averaging an increase of 1431 steps per day by the end of the study.

The results showed that poor sleep quality was linked to lower physical activity at baseline, highlighting the importance of effective OSA treatment in enhancing both sleep and activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in Physical Activity in Persons With Obstructive Sleep Apnea Treated With Continuous Positive Airway Pressure. Jean, RE., Duttuluri, M., Gibson, CD., et al.[2018]

Interval exercise training (IET) showed greater improvements in peak work rate and reduced exercise-induced dyspnoea compared to continuous exercise training (CET) in a meta-analysis of 13 trials involving 530 patients with chronic respiratory diseases.

Despite these improvements, the benefits of IET did not reach a level considered clinically meaningful, indicating that while IET may be slightly better, both training types are effective for patients with chronic respiratory diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of interval compared to continuous exercise training on physiological responses in patients with chronic respiratory diseases: A systematic review and meta-analysis. Alexiou, C., Ward, L., Hume, E., et al.[2021]

A new physical activity education program (EDU) for COPD patients was found to be as effective and safe as traditional combined strength-endurance training (CT) in improving health-related factors like walking capacity and quality of life over a 28-week training period.

Both EDU and CT showed improvements in health parameters, but these benefits were not sustained after a 14-week follow-up, indicating the need for ongoing physical activity to maintain gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Combined Aerobic-Strength Training vs Fitness Education Program in COPD Patients. Rinaldo, N., Bacchi, E., Coratella, G., et al.[2018]

In a study of 18 patients with severe COPD, interval training combined with non-invasive ventilation (NIV) significantly improved exercise capacity, as shown by a notable increase in the 6-minute walking distance from 216 meters to 274 meters (P<0.001).

The intervention also enhanced quality of life and respiratory function, with significant improvements in the COPD Assessment Test scores and inspiratory vital capacity, indicating that IT with NIV is a safe and effective rehabilitation strategy for patients with severe COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of interval training with non-invasive ventilation in severe chronic obstructive pulmonary disease-a prospective cohort study with matched control group. Fekete, M., Kerti, M., Fazekas-Pongor, V., et al.[2021]

Patients with obstructive sleep apnea (OSA) have low levels of physical activity, averaging only 5,388 steps per day, which is significantly below the recommended 10,000 steps.

Exercise training in OSA patients leads to a meaningful reduction in apnea-hypopnea events (average decrease of 8.9 events/hour) and improves cardiorespiratory fitness (VO2peak), while also reducing feelings of sleepiness, indicating that exercise can be an effective intervention for managing OSA severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstructive Sleep Apnea Syndrome, Objectively Measured Physical Activity and Exercise Training Interventions: A Systematic Review and Meta-Analysis. Mendelson, M., Bailly, S., Marillier, M., et al.[2020]

Physical activity is crucial for patients with chronic obstructive pulmonary disease (COPD) as it can help prevent lung function decline and reduce hospitalizations and mortality rates.

The European Respiratory Society emphasizes the need for further research on how increasing physical activity can modify the disease and improve patients' exercise capacity and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An official European Respiratory Society statement on physical activity in COPD. Watz, H., Pitta, F., Rochester, CL., et al.[2022]

A novel Internet-mediated, pedometer-based exercise intervention for veterans with COPD led to significant improvements in health-related quality of life (HRQL) domains, particularly in Symptoms and Impact, after 4 months.

Participants in the intervention group increased their daily step counts by an average of 779 steps compared to the control group, indicating that the program effectively encouraged physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Moy, ML., Collins, RJ., Martinez, CH., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11439968/

EFFICACY OF PULMONARY REHABILITATION IN ... Pulmonary rehabilitation incorporating moderate-intensity aerobic exercise could improve physical endurance and motor abilities in individuals with chronic ...

2. resmedjournal.com resmedjournal.com/article/S0954-6111(23)00016-1/fulltext

High-intensity interval training improves the outcomes of ... HIIT may be beneficial to improve the pulmonary function, exercise capacity and quality of life of patients with COPD, which is worthy of clinical promotion.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12034842/

Association Between Physical Activity, Sedentary Behavior ... Long-term sedentary behavior was associated with elevated risk of sleep disorders in COPD patients. More light intensity physical activity and ...

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11310

Effects of aerobic exercise and resistance training on ... Our meta-analysis revealed a significant ESS reduction of −2.37 with exercise, which is comparable to the effect of exercise training and even CPAP reported ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0954611123000161

High-intensity interval training improves the outcomes of ... High-intensity interval training improves the outcomes of patients with chronic obstructive pulmonary disease: A meta-analysis of randomized controlled trials.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9354440/

Physical activity and chronic obstructive pulmonary disease Reduced physical activity (PA) was the strongest predictor of all-cause mortality in patients with chronic obstructive pulmonary disease ...