Inclined walking versus standard treadmill walking for people with COPD

Inducing Variable Breathing Ratios During Walking to Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease.

This trial will test whether walking on an incline during pulmonary rehabilitation helps people with COPD breathe and walk with less shortness of breath compared to walking faster on a flat treadmill.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 45 Years to 80 Years
• Sex: All
• Sponsor: VA Office of Research and Development (Federal)
• Locations: 1 site (Omaha, Nebraska)
• Trial ID: NCT06749262 on ClinicalTrials.gov

What this trial studies

This randomized interventional study will enroll about 56 veterans with COPD, assigning 28 to an inclined-walking pulmonary rehab program and 28 to a standard speed-increase flat-walking program over 12 weeks (three sessions per week). Participants complete baseline post-bronchodilator spirometry and a maximal cardiopulmonary exercise test for physician clearance, and treadmill sessions are monitored using the Q-stress system. Up to 108 people may be consented and screened to reach the enrollment target, and the program is conducted at the Omaha VA and the Nebraska Cardiac Pulmonary Rehab Center. Outcomes will compare breathing, walking performance, and symptom response between the two training approaches.

Who should consider this trial

Good fit: Veteran adults with stable COPD, post-bronchodilator FEV1/FVC < 0.7 and FEV1 30–80% predicted, BMI < 35 kg/m2, able to walk on a treadmill, and medically cleared after a cardiopulmonary exercise test are ideal candidates.

Not a fit: People who require supplemental oxygen at rest or with activity, have significant neurological, musculoskeletal, or metabolic disorders, BMI ≥ 35, take excluded medications, or cannot be cleared by CPET are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, this approach could reduce breathlessness during exertion and improve walking ability for some people with COPD.

How similar studies have performed: Pulmonary rehabilitation and treadmill training are established to help many COPD patients, but direct comparisons of inclined versus faster flat treadmill training are limited, making this a relatively novel specific comparison.

Eligibility criteria

Inclusion Criteria:

* Veterans from all sex/gender, race, and ethnicity will be recruited
* All subjects will undergo post-bronchodilator spirometry and be clinically stable
* All subjects must have documented FEV1/FVC ratio of \<0.7, and between 30% to 80% FEV1% predicted
* If subjects have non-qualifying spirometry, they will not be screened further
* Subjects with qualifying spirometry will be screened further
* Potential subjects must have a BMI of less than 35 kg/m2 and must be free from co-morbidities that may affect walking patterns

  * e.g., peripheral arterial disease, diabetes, low back pain

Exclusion Criteria:

* Confounding effects such as neurological, musculoskeletal, or metabolic disease
* Subjects taking medications that alter mood or metabolic demand will be excluded
* All potential subjects must be cleared for participation by a physician after undergoing a cardiopulmonary exercise test
* Require an O2 mask during rest or activity

Where this trial is running

Omaha, Nebraska

• Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States (Recruiting)

Study contacts

• Principal investigator: Kristina L Bailey — Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
• Study coordinator: Farahnaz Fallahtafti, PhD

Conditions Chronic Obstructive Pulmonary Disease; pulmonary rehabilitation