Recruiting

Pulmonary Rehabilitation

Sponsor:

VA Office of Research and Development

Code:

NCT06749262

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

walking on incline or walking at increasing speed for 36 visits

Study Details

Brief summary:

This study is designed to provide information regarding how to improve pulmonary rehabilitation for persons with chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation is an exercise program for COPD patients that is recommended and benefits some, but not all, patients. The question being studied in this trial is whether during an exercise program, walking on an incline might be better than walking on faster on a flat surface in training muscles so that patients might be less short of breath with exercise.

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT06749262

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Walking at Incline

Subjects will walk on treadmill at slope equal to 60% of their peak heart rate as determined on baseline cardiopulmonary exercise test.

experimental: Walking at Speed

Subjects will walk on treadmill at speed equal to 60% of their peak heart rate as determined on baseline cardiopulmonary exercise test.

Interventions

walking on incline or walking at increasing speed for 36 visits

Subjects will be prepared for data collection by wearing an exercise suit and obtaining height and body weight. Breathing sensors and foot switches will be worn to measure breathing and walking performance.

Primary outcome measure

  • Respiratory rate [ Time Frame: During each session of Exercise up to 12 weeks ]
  • Dyspnea [ Time Frame: During each session of Exercise up to 12 weeks ]
  • Dynamic hyperinflation [ Time Frame: During each session of Exercise up to 12 weeks ]
  • Total walking time [ Time Frame: During each session of Exercise up to 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Recruiting

Omaha, Nebraska, United States, 68105-1850

Contacts

Principal Investigator:

Kristina L Bailey

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • pulmonary rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-13.