Interval Exercise for COPD and Sleep Apnea
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Cad, Orthopedic problems, Fall risk, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
16789How 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.
210111213Eligibility 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.
+3 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Salem VA Medical Center, Salem, VASalem, VA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
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]Low levels of physical activity (PA) are associated with poor outcomes in people with COPD. Interventions to increase PA could improve outcomes.
Effect of interval compared to continuous exercise training on physiological responses in patients with chronic respiratory diseases: A systematic review and meta-analysis. [2021]BackgroundCurrent evidence suggests that interval exercise training (IET) and continuous exercise training (CET) produce comparable benefits in exercise capacity, cardiorespiratory fitness and symptoms in patients with chronic obstructive pulmonary disease (COPD). However, the effects of these modalities have only been reviewed in patients with COPD. This meta-analysis compares the effectiveness of IET versus CET on exercise capacity, cardiorespiratory fitness and exertional symptoms in patients with chronic respiratory diseases (CRDs). Methods: PubMed, CINHAL, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL) and Nursing and Allied health were searched for randomised controlled trials from inception to September 2020. Eligible studies included the comparison between IET and CET, reporting measures of exercise capacity, cardiorespiratory fitness and symptoms in individuals with CRDs. Results: Thirteen randomised control trials (530 patients with CRDs) with fair to good quality on the PEDro scale were included. Eleven studies involved n = 446 patients with COPD, one involved n = 24 patients with cystic fibrosis (CF) and one n = 60 lung transplantation (LT) candidates. IET resulted in greater improvements in peak work rate (WRpeak) (2.40 W, 95% CI: 0.83 to 3.97 W; p = 0.003) and lower exercise-induced dyspnoea (-0.47, 95% CI: -0.86 to 0.09; p = 0.02) compared to CET; however, these improvements did not exceed the minimal important difference for these outcomes. No significant differences in peak values for oxygen uptake (VO2peak), heart rate (HRpeak), minute ventilation (VEpeak), lactate threshold (LAT) and leg discomfort were found between the interventions. Conclusions: IET is superior to CET in improving exercise capacity and exercise-induced dyspnoea sensations in patients with CRDs; however, the extent of the clinical benefit is not considered clinically meaningful.
Interventions to increase physical activity in people with COPD: systematic review. [2018]People with chronic obstructive pulmonary disease (COPD) are very sedentary and this contributes to their health problems. The aim of this systematic review was to examine the effects of interventions designed to increase physical activity (PA) in people with COPD. Studies were included when PA was the primary outcome and measured objectively. Six databases were searched and 15 studies with a total of 761 subjects were identified that met inclusion criteria. Nine of the studies were quasi-experimental (QE) and six were randomized controlled trials (RCT). Interventions included pulmonary rehabilitation (n = 7), exercise only (n = 2), behavioral only (n = 2) and a combination of both behavioral and pulmonary rehabilitation/exercise interventions (n = 4). Methodological quality was evaluated using the Downs and Black checklist. The quality of the pulmonary rehabilitation studies was the lowest with a fair rating and the quality of exercise only studies was the highest with a good rating. Eight of the 15 studies demonstrated statistically significant increases in PA: two pulmonary rehabilitation (QE = 2), two exercise only (RCT = 2), two behavioral only (RCT = 1, QE = 1), and two combined behavioral and pulmonary rehabilitation/exercise (RCT = 2). The magnitude of increase was modest in all but one study; and in many studies the increase in PA was not clinically meaningful. Longer interventions demonstrated a higher success rate and only three studies examined longer term effects of the interventions. Existing interventions are promising, but the small number of randomized controlled trials makes it difficult to draw conclusion. Further research is needed to identify a range of interventions that are effective and could be used to promote PA in people with COPD.
Intervention by phone calls raises domiciliary activity and exercise capacity in patients with severe COPD. [2007]Patients with severe COPD suffer from impairments of exercise capacity which affects daily activity. Conversely, activity might exert effects on the functional state. We studied whether a short-term intervention by regular phone calls caused an increase in activity at home and whether this resulted in a gain in exercise capacity.
Interval exercise versus continuous exercise in patients with moderate to severe chronic obstructive pulmonary disease--study protocol for a randomised controlled trial [ISRCTN11611768]. [2018]Physical exercise has become a cornerstone of management of chronic obstructive pulmonary disease (COPD) because it leads to clinically relevant improvements of exercise capacity and health-related quality of life (HRQL). Despite the scarcity of randomised trials directly comparing exercise protocols, current guidelines recommend high intensity continuous exercise for lower extremities as the probably most effective exercise modality. However, for patients admitted to inpatient respiratory rehabilitation programmes, it is often difficult to initiate such an exercise programme because they are severely limited by dyspnoea and leg fatigue and therefore unable to perform continuous exercise at higher intensities and for periods longer than 30 minutes. Interval exercise may be an attractive alternative for these COPD patients because it allows high intensity exercise with recovery periods. The aim of this study is to assess if interval exercise compared to high intensity continuous exercise is not of inferior effectiveness in terms of HRQL and exercise capacity improvements but associated with better exercise tolerance in patients with moderate to severe COPD at the beginning of a respiratory rehabilitation.
Does exercise training change physical activity in people with COPD? A systematic review and meta-analysis. [2022]A systematic review and meta-analysis was conducted to examine the effect of exercise training on daily physical activity (PA) in people with chronic obstructive pulmonary disease (COPD). MEDLINE, PubMed, EMBASE, CINAHL, Physiotherapy Evidence Database (PEDro) and Cochrane Central Register of Controlled Trials were searched from their inception to week 27 of 2010, using the keywords 'COPD,' 'exercise,' 'therapy' and 'physical activity.' All studies except case reports were eligible for inclusion provided they investigated the effects of ≥4 weeks of supervised exercise training on PA in patients with COPD. Study quality for the randomised trials (RTs) and single-group interventional studies was rated using the PEDro scale and Downs and Black Tool, respectively. No randomised controlled trials met our study criteria. The two RTs had a mean PEDro score of 5. The 5 single-group studies had a mean Downs and Black score of 19 ± 3. When combined, a small effect on PA outcomes was demonstrated (overall mean effect = 0.12; p = 0.01). Taken together, the RTs and single-group studies demonstrate that exercise training may confer a significant but small increase in PA.
Effects of Combined Aerobic-Strength Training vs Fitness Education Program in COPD Patients. [2018]We compared the effects of a new physical activity education program approach (EDU), based on a periodically supervised protocol of different exercise modalities vs traditionally supervised combined strength-endurance training (CT) on health-related factors in patients with stable chronic obstructive pulmonary disease (COPD). Twenty-eight COPD patients without comorbidities were randomly assigned to receive either EDU or CT. CT was continuously supervised to combine strength-endurance training; EDU was taught to progressively increase the rate of autonomous physical activity, through different training modalities such as Nordic walking, group classes and circuit training. Body composition, walking capacity, muscle strength, flexibility and balance, total daily energy expenditure and quality of life were evaluated at baseline, after 28 weeks training period (3d/week) and after a 14-week follow-up. No adverse events occurred during the interventions. After training, CT and EDU similarly improved walking capacity, body composition and quality of life. However, after 14 weeks of follow-up, such improvements were not maintained. Only in CT, muscle strength and flexibility improved after training but returned to baseline after follow-up. EDU, similar to CT, can effectively and safely improve health-related parameters in COPD patients. EDU could be an attractive alternative to traditional supervised training for improving quality of life in COPD patients.
COPD: benefits of exercise training. [2016]In patients with stable, moderate or severe chronic obstructive pulmonary disease (COPD), general exercise training, including limb exercises, provides sustained improvement in various quality of life domains, compared with care without pulmonary rehabilitation. After a COPD exacerbation, exercise training appears to reduce the risk of hospitalisation in the following months by at least half. Few studies have evaluated the adverse effects of exercise training in COPD, but based on the data available in 2015, its harm-benefit balance appears favourable.
An official European Respiratory Society statement on physical activity in COPD. [2022]This European Respiratory Society (ERS) statement provides a comprehensive overview on physical activity in patients with chronic obstructive pulmonary disease (COPD). A multidisciplinary Task Force of experts representing the ERS Scientific Group 01.02 "Rehabilitation and Chronic Care" determined the overall scope of this statement through consensus. Focused literature reviews were conducted in key topic areas and the final content of this Statement was agreed upon by all members. The current knowledge regarding physical activity in COPD is presented, including the definition of physical activity, the consequences of physical inactivity on lung function decline and COPD incidence, physical activity assessment, prevalence of physical inactivity in COPD, clinical correlates of physical activity, effects of physical inactivity on hospitalisations and mortality, and treatment strategies to improve physical activity in patients with COPD. This Task Force identified multiple major areas of research that need to be addressed further in the coming years. These include, but are not limited to, the disease-modifying potential of increased physical activity, and to further understand how improvements in exercise capacity, dyspnoea and self-efficacy following interventions may translate into increased physical activity. The Task Force recommends that this ERS statement should be reviewed periodically (e.g. every 5-8 years).
Effect of interval training with non-invasive ventilation in severe chronic obstructive pulmonary disease-a prospective cohort study with matched control group. [2021]In severe chronic obstructive pulmonary disease (COPD), interval training (IT) can be performed with oxygen support, which provides beneficial effect on metabolic processes, tissue perfusion, and peripheral muscle function.
Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review. [2022]In patients with chronic obstructive pulmonary disease (COPD), interval exercise has gained recent attention as a possible means of achieving greater physiological training effects compared with continuous exercise. The primary aim of this systematic review was to compare the effects of interval versus continuous training on peak oxygen uptake, peak power, 6 minute walk test (6MWT) distance and health-related quality of life in individuals with COPD.
Obstructive Sleep Apnea Syndrome, Objectively Measured Physical Activity and Exercise Training Interventions: A Systematic Review and Meta-Analysis. [2020]A systematic review of English and French articles using Pubmed/Medline and Embase included studies assessing objective physical activity levels of obstructive sleep apnea (OSA) patients and exploring the effects of exercise training on OSA severity, body mass index (BMI), sleepiness, and cardiorespiratory fitness [peak oxygen consumption (VO2peak)]. Two independent reviewers analyzed the studies, extracted the data, and assessed the quality of evidence. For objective physical activity levels, eight studies were included. The mean number of steps per day across studies was 5,388 (95% CI: 3,831-6,945; p < 0.001), which was by far lower than the recommended threshold of 10,000 steps per day. For exercise training, six randomized trials were included. There was a significant decrease in apnea-hypopnea-index following exercise training (mean decrease of 8.9 events/h; 95% CI: -13.4 to -4.3; p < 0.01), which was accompanied by a reduction in subjective sleepiness, an increase in VO2peak and no change in BMI. OSA patients present low levels of physical activity and exercise training is associated with improved outcomes. Future interventions (including exercise training) focusing on increasing physical activity levels may have important clinical impacts on both OSA severity and the burden of associated co-morbidities. Objective measurement of physical activity in routine OSA management and well-designed clinical trials are recommended. Registration # CRD42017057319 (Prospero).
Improvement in Physical Activity in Persons With Obstructive Sleep Apnea Treated With Continuous Positive Airway Pressure. [2018]Exercise improves sleep quality, yet people with untreated obstructive sleep apnea (OSA) may engage in less physical activity (PA) due to fatigue and daytime sleepiness. We examined changes in PA and sleep quality before and after treatment with continuous positive airway pressure (CPAP) in OSA patients.