Inclined Versus Standard Exercise for COPD Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: walking on incline or walking at increasing speed for 36 visits

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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara A Myers, PhD; Phone Number: (402) 554-3246; Email: Sara.Myers2@va.gov
• Study Contact Backup: Name: Farahnaz Fallahtafti, PhD; Phone Number: (402) 995-3542; Email: Farahnaz.Fallahtafti@va.gov

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68105-1850
      • Recruiting
      • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
      • Contact: Amy M Patten; Phone Number: (402) 995-3541; Email: amy.patten@va.gov
      • Contact: Wendy A Inselman; Phone Number: 3940 (402) 346-8800; Email: wendy.inselman@va.gov
      • Sub-Investigator: Sara A. Myers, PhD
      • Sub-Investigator: Farahnaz Fallahtafti, PhD
      • Principal Investigator: Kristina L Bailey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locomotor respiratory coupling (LRC)	The investigators will measure synchronized respiratory cycles using RIP bands and walking cycles using SMTEC footswitch system (Sport & Medical Technologies SA, Nyon, Switzerland) to detect gait events. LRC is often quantified as frequency coupling. Frequency coupling refers to how many heel strikes occur within a single cycle of respiration (one inhalation to the next); it is usually counted in integer or half-integer ratios, measured using discrete relative phase between walking (heel strikes) and breathing rhythms time series. Discrete relative phase values between 0º-360º have a 1:1 relationship, 360º-720º have a 2:1 relationship, 720º-1080º have a 3:1 relationship, and so on. Half-integer couplings (expressed as 3:2, 5:2, 7:2, etc.) exist when the frequency alternates between two integers. The range of ratios and the percentage of time each ratio is utilized will be recorded.	During each session of Exercise up to 12 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Nebraska
• Investigators: Principal Investigator: Kristina L Bailey, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: F5337-R; I01RX005337-01A1 (U.S. NIH Grant/Contract: VA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No