28 Participants Needed

Interval Exercise for COPD and Sleep Apnea

DJ
TA
Overseen ByTracy A Hicks
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The term "Overlap Syndrome" (OS) is used to describe the presence of both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in a single patient. Due to premature aging, patients with OS are prone to developing functional decline up to 20 years earlier than the general population. The International Classification of Functioning, Disability and Health (ICF) evaluates functional status in chronic pulmonary disease globally in 5 domains. The investigators propose to study validated outcomes in 3 of these domains: 1) participation in life situations; 2) physical activity; and 3) cardiovascular health. The investigators long-term goal is to develop an exercise strategy tailored to Veterans with OS which will reduce the risk of functional decline through increased PA.

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 data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for COPD and Sleep Apnea?

Research shows that increasing physical activity can improve health outcomes for people with COPD, and interval exercise training can enhance exercise capacity and reduce breathlessness. Although the improvements are not always clinically significant, these findings suggest that exercise can be beneficial for managing COPD.12345

Is interval exercise safe for people with COPD and sleep apnea?

Exercise programs, including interval exercise, have been shown to be safe for people with COPD, with no adverse events reported in studies. These programs can improve health-related factors like walking capacity and quality of life without causing harm.16789

How does interval exercise differ from other treatments for COPD and sleep apnea?

Interval exercise is unique because it involves short bursts of intense activity followed by rest, which can improve exercise capacity and reduce breathlessness more effectively than continuous exercise. This approach is particularly beneficial for COPD and sleep apnea patients, as it can enhance muscle function and reduce sleep apnea severity without the need for medication.210111213

Research Team

MM

Madalina Macrea, MD PhD

Principal Investigator

Salem VA Medical Center, Salem, VA

Eligibility Criteria

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.
See 3 more

Timeline

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

Treatment Details

Interventions

  • Exercise
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment1 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 CareActive Control1 Intervention
Participants in the control group will be instructed to maintain their routine activity level for 12 weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

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

References

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. [2022]
Effect of interval compared to continuous exercise training on physiological responses in patients with chronic respiratory diseases: A systematic review and meta-analysis. [2021]
Interventions to increase physical activity in people with COPD: systematic review. [2018]
Intervention by phone calls raises domiciliary activity and exercise capacity in patients with severe COPD. [2007]
Interval exercise versus continuous exercise in patients with moderate to severe chronic obstructive pulmonary disease--study protocol for a randomised controlled trial [ISRCTN11611768]. [2018]
Does exercise training change physical activity in people with COPD? A systematic review and meta-analysis. [2022]
Effects of Combined Aerobic-Strength Training vs Fitness Education Program in COPD Patients. [2018]
COPD: benefits of exercise training. [2016]
An official European Respiratory Society statement on physical activity in COPD. [2022]
Effect of interval training with non-invasive ventilation in severe chronic obstructive pulmonary disease-a prospective cohort study with matched control group. [2021]
Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review. [2022]
Obstructive Sleep Apnea Syndrome, Objectively Measured Physical Activity and Exercise Training Interventions: A Systematic Review and Meta-Analysis. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Improvement in Physical Activity in Persons With Obstructive Sleep Apnea Treated With Continuous Positive Airway Pressure. [2018]