Chronic Obstructive Pulmonary DiseaseNCT06749262
Inclined Versus Standard Exercise for COPD Patients
A study testing walking on incline or walking at increasing speed for 36 visits in people with Chronic Obstructive Pulmonary Disease, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- walking on incline or walking at increasing speed for 36 visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
Amy M Patten, (402) 995-3541, amy.patten@va.gov
Wendy A Inselman, (402) 346-8800 ext. 3940, wendy.inselman@va.gov
About this study
Official title: Inducing Variable Breathing Ratios During Walking to Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease.
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.
Read the detailed description
Objective: The objective of this project is to determine the effect of a pulmonary rehabilitation program that utilizes inclined versus standard exercise to improve breathing and walking for individuals with COPD.
Research Design: Fifty-six patients with COPD (28 in each treatment group: inclined or standard rehabilitation) will be recruited through the VA Nebraska-Western Iowa Health Center clinics. Patients will be randomly assigned to either inclined or standard rehabilitation groups and participate in a 12-week pulmonary rehab program (3 sessions/ week). Potential research subjects will undergo a medical history exam \& pulmonary function test at the Omaha VA, and a maximal cardiopulmonary exercise test (CPET) at the Nebraska Cardiac Pulmonary Rehab Center (Rehab Center). Only those that are cleared for participation by a physician will be enrolled.
Methodology: The study will be conducted at the Omaha VA and the Rehab Center. All subjects will be diagnosed with chronic obstructive pulmonary disease (COPD) with no other significant co-morbidities and screened for eligibility. Up to 108 patients may be consented and screened to achieve target enrollment of 58 subjects.
Enrolled participants will first complete a series of questionnaires that will be used as covariates in the analysis at the Rehab Center then proceed with their first rehab session.
The Q-stress system, connected to the participants while they walk on a treadmill, will be used to monitor participants' cardiovascular responses. The treadmill's speed and incline will be incrementally increased until the participants reach 60% of their maximal heart rate as determined by the CPET. For both the standard treadmill walking and incline walking, the goal is to achieve 30 minutes of walking at the 60% intensity without a break at the end of the 12 weeks. For the standard walking, subjects will walk at their preferred speed, on a 0% level surface of the treadmill. The treadmill speed will be incrementally enhanced by 0.05 meters per second each minute until the participant's heart rate attains 60% of the maximal heart rate recorded during the CPET. With the inclined treadmill walking group, participants will begin walking at a pace 20% below their preferred walking speed on a 2% incline, which will then be elevated by 0.5% each minute. Each session will last up to 50 minutes plus 5 minutes of warm-up and cool-down. After completing a session, interviews and questionnaires will be used to assess comfort, fatigue, and exercise intensity.
Outcome measures from the Q-stress system are respiratory flow pattern, dyspnea, dynamic hyperinflation, LRC ratio, total walking time and metabolic equivalence of task (METs).
Clinical relationship: COPD is a major health concern for the Department of Veterans Affairs. Current pulmonary rehabilitation programs do not consistently improve outcomes. Enhancing the effectiveness of these programs could significantly improve patient outcomes. The investigators hypothesize that inclined walking will reduce respiratory rate, dynamic hyperinflation, and dyspnea, thereby improving exercise capacity and quality of life for these patients. These findings can be incorporated into rehabilitation practices, reducing the disability linked to the disease and enhancing the overall health outcomes for Veterans.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- walking on incline or walking at increasing speed for 36 visits
- Keywords
- pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking on incline or walking at increasing speed for 36 visitsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Walking at Incline | Experimental | Subjects will walk on treadmill at slope equal to 60% of their peak heart rate as determined on baseline cardiopulmonary exercise test. Receives: Other: walking on incline or walking at increasing speed for 36 visits |
| Walking at Speed | Experimental | Subjects will walk on treadmill at speed equal to 60% of their peak heart rate as determined on baseline cardiopulmonary exercise test. Receives: Other: walking on incline or walking at increasing speed for 36 visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate
Respiratory rate will be analyzed using motion capture markers on the chest. With custom computer code, the markers will be identified to model a sphere. The volume of the sphere will be recorded over time. As the volume increases and decreases, respiratory flow will be identified, and respiratory rate can be calculated.
Measured: During each session of Exercise up to 12 weeks
Dyspnea
Perceived dyspnea: Breathlessness will be measured based on a 0 to 10-point Borg scale at the end of the treadmill trials. 0 on scale is no breathlessness and 10 is maximal breathlessness
Measured: During each session of Exercise up to 12 weeks
Dynamic hyperinflation
Dynamic hyperinflation will be assessed by inspiratory capacity through pre- and post-walking trial resting spirometry. Dynamic hyperinflation will be considered to be present when inspiratory capacity values decrease after walking trials when compared to resting values.
Measured: During each session of Exercise up to 12 weeks
Total walking time
Total walking time will be assessed by measuring the time that each participant walks during an exercise session
Measured: During each session of Exercise up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Apr 2026
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional longitudinal study
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Kristina L Bailey, Principal investigator, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749262
- Sponsor's protocol ID
- F5337-R
- Other IDs
- I01RX005337-01A1
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inducing Variable Breathing Ratios During Walking to Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT06749262
- Acronym / sponsor ID
- F5337-R
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Nebraska
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: The objective of this project is to determine the effect of a pulmonary rehabilitation program that utilizes inclined versus standard exercise to improve breathing and walking for individuals with COPD.
Research Design: Fifty-six patients with COPD (28 in each treatment group: inclined or standard rehabilitation) will be recruited through the VA Nebraska-Western Iowa Health Center clinics. Patients will be randomly assigned to either inclined or standard rehabilitation groups and participate in a 12-week pulmonary rehab program (3 sessions/ week). Potential research subjects will undergo a medical history exam \& pulmonary function test at the Omaha VA, and a maximal cardiopulmonary exercise test (CPET) at the Nebraska Cardiac Pulmonary Rehab Center (Rehab Center). Only those that are cleared for participation by a physician will be enrolled.
Methodology: The study will be conducted at the Omaha VA and the Rehab Center. All subjects will be diagnosed with chronic obstructive pulmonary disease (COPD) with no other significant co-morbidities and screened for eligibility. Up to 108 patients may be consented and screened to achieve target enrollment of 58 subjects.
Enrolled participants will first complete a series of questionnaires that will be used as covariates in the analysis at the Rehab Center then proceed with their first rehab session.
The Q-stress system, connected to the participants while they walk on a treadmill, will be used to monitor participants' cardiovascular responses. The treadmill's speed and incline will be incrementally increased until the participants reach 60% of their maximal heart rate as determined by the CPET. For both the standard treadmill walking and incline walking, the goal is to achieve 30 minutes of walking at the 60% intensity without a break at the end of the 12 weeks. For the standard walking, subjects will walk at their preferred speed, on a 0% level surface of the treadmill. The treadmill speed will be incrementally enhanced by 0.05 meters per second each minute until the participant's heart rate attains 60% of the maximal heart rate recorded during the CPET. With the inclined treadmill walking group, participants will begin walking at a pace 20% below their preferred walking speed on a 2% incline, which will then be elevated by 0.5% each minute. Each session will last up to 50 minutes plus 5 minutes of warm-up and cool-down. After completing a session, interviews and questionnaires will be used to assess comfort, fatigue, and exercise intensity.
Outcome measures from the Q-stress system are respiratory flow pattern, dyspnea, dynamic hyperinflation, LRC ratio, total walking time and metabolic equivalence of task (METs).
Clinical relationship: COPD is a major health concern for the Department of Veterans Affairs. Current pulmonary rehabilitation programs do not consistently improve outcomes. Enhancing the effectiveness of these programs could significantly improve patient outcomes. The investigators hypothesize that inclined walking will reduce respiratory rate, dynamic hyperinflation, and dyspnea, thereby improving exercise capacity and quality of life for these patients. These findings can be incorporated into rehabilitation practices, reducing the disability linked to the disease and enhancing the overall health outcomes for Veterans.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional longitudinal study
| Arm | Type | Receives |
|---|---|---|
| Walking at Incline | Experimental | Other: walking on incline or walking at increasing speed for 36 visitsSubjects will walk on treadmill at slope equal to 60% of their peak heart rate as determined on baseline cardiopulmonary exercise test. |
| Walking at Speed | Experimental | Other: walking on incline or walking at increasing speed for 36 visitsSubjects will walk on treadmill at speed equal to 60% of their peak heart rate as determined on baseline cardiopulmonary exercise test. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking on incline or walking at increasing speed for 36 visitsSubjects 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. | Other | Walking at Incline, Walking at Speed |
Primary outcome
Respiratory rate
Time frame: During each session of Exercise up to 12 weeks
Respiratory rate will be analyzed using motion capture markers on the chest. With custom computer code, the markers will be identified to model a sphere. The volume of the sphere will be recorded over time. As the volume increases and decreases, respiratory flow will be identified, and respiratory rate can be calculated.
Dyspnea
Time frame: During each session of Exercise up to 12 weeks
Perceived dyspnea: Breathlessness will be measured based on a 0 to 10-point Borg scale at the end of the treadmill trials. 0 on scale is no breathlessness and 10 is maximal breathlessness
Dynamic hyperinflation
Time frame: During each session of Exercise up to 12 weeks
Dynamic hyperinflation will be assessed by inspiratory capacity through pre- and post-walking trial resting spirometry. Dynamic hyperinflation will be considered to be present when inspiratory capacity values decrease after walking trials when compared to resting values.
Total walking time
Time frame: During each session of Exercise up to 12 weeks
Total walking time will be assessed by measuring the time that each participant walks during an exercise session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristina L Bailey principal investigator
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking on incline or walking at increasing speed for 36 visits in people with Chronic Obstructive Pulmonary Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farahnaz Fallahtafti, PhD ((402) 995-3542, Farahnaz.Fallahtafti@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate (time frame: During each session of Exercise up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.