Inclined Versus Standard Exercise for COPD Patients

NCT06749262 | Recruiting DMC

• 2 other identifiers: F5337-RI01RX005337-01A1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Keywords

pulmonary rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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

  During each session of Exercise up to 12 weeks

Other Outcomes (1)

• Locomotor respiratory coupling (LRC)

  During each session of Exercise up to 12 weeks

Study Arms (2)

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.

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.

Other: walking on incline or walking at increasing speed for 36 visits

Interventions

walking on incline or walking at increasing speed for 36 visits OTHER

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.

Walking at Incline; Walking at Speed

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: collaborator
• VA Office of Research and Development: lead

Study Sites (1)

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

Omaha, Nebraska, 68105-1850, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristina L Bailey

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farahnaz Fallahtafti, PhD

CONTACT

(402) 995-3542; Farahnaz.Fallahtafti@va.gov

Sara A Myers, PhD

CONTACT

(402) 554-3246; Sara.Myers2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Interventional longitudinal study

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)