Uphill Walking as Exercise for COPD Patients

NCT ID: NCT04026529

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2022-09-30

Brief Summary

This study is designed to provide preliminary 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 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

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality and presents an important healthcare problem, especially for Veterans. Prevalence of COPD in the Veteran population ranges from 33%-43%, a higher prevalence than among the general population of the United States. COPD patients experience diminished exercise capacity. A significant portion of this limitation in exercise capacity is due to dynamic hyperinflation and dyspnea. Humans demonstrate a coupled relationship between walking and breathing. The investigators' preliminary data indicates that patients with COPD demonstrate an abnormal coupling pattern compared to those without COPD, using one stride for one breath, even at speeds outside of their self-selected walking pace. Current pulmonary rehabilitation relies on increasing intensity of exercise through accelerated walking. Based on coupling patterns in patients with COPD, increasing speed leads to an increase in respiratory rate, dynamic hyperinflation, and dyspnea, thus limiting exercise time. The goal of this proposed project is to investigate, in Veteran COPD patients, the effect of walking faster vs. walking on a slope on dynamic hyperinflation and dyspnea, oxygen uptake and dead space, and walking and breathing coupling. The investigators hypothesize that walking on a slope will alter breathing and walking coupling, lower respiratory rates, and reduce dynamic hyperinflation and associated dyspnea. The investigators predict that walking on a slope will permit an increase in oxygen uptake and a decrease in dead space in patients with COPD as compared to accelerated walking speeds. These hypotheses will be tested through three aims: 1) Identify differences in dynamic hyperinflation and dyspnea; 2) Compare differences in respiratory rate, oxygen uptake, and lung dead space; 3) Determine the complexity of walking and breathing coupling ratios. In this cross-sectional study, Veterans with COPD will be recruited and screened using a cardiopulmonary exercise test. A total of 25 eligible Veterans will be enrolled through stratified sampling of disease severity. The time course of work rate will be calculated from the cardiopulmonary exercise test. The speed and slope that corresponds to 60% of peak work rate will be used. An additional constant work rate test will be given using increases in speed with a level treadmill to determine the speed that elicits oxygen uptake comparable to the sloped walking test. Subjects will be asked to perform two experimental trials (walking faster vs. walking on a slope) at 60% peak work rate. Measures of dynamic hyperinflation, dyspnea, oxygen uptake, dead space, and coupling will be recorded during all walking trials. Possible covariates will also be collected. The investigators anticipate that dynamic hyperinflation and dyspnea will be reduced in patients with COPD due to slower walking and slower respiratory rates during sloped walking as compared to faster level walking. It is expected that this will be influenced by the complexity in breathing and walking coupling ratios. The investigators' multidisciplinary team will provide combined expertise from several disciplines and is uniquely qualified to complete the aims proposed. Results from this feasibility and acceptability study will set the stage for a rigorous, well-powered, full Merit award outcome study evaluating the effectiveness of a slope-based training regimen as part of rehabilitation.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

walking at incline

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

Group Type: EXPERIMENTAL

walking on incline or walking at increasing speed

Intervention Type: OTHER

Subjects will be prepared for data collection by wearing a form-fitting suit (i.e., wrestling singlet) and obtaining height and body weight. Retro-reflective markers will be placed bilaterally on anatomical locations of the feet, legs, and hips.

Subjects will be outfitted with the portable metabolic cart and oximeter as in the previous visit. One of two treadmill trials will be performed: 1) at the speed and 2) at the slope +speed determined in the previous visit. Trial order will be randomized among subjects and across visits 3 & 4. For each trial, subjects will be asked to walk on a treadmill for up to 6 minutes. Speed or slope will be increased every 30 seconds and they will be asked to walk for one minute at that speed or slope.

Interventions

walking on incline or walking at increasing speed

Subjects will be prepared for data collection by wearing a form-fitting suit (i.e., wrestling singlet) and obtaining height and body weight. Retro-reflective markers will be placed bilaterally on anatomical locations of the feet, legs, and hips.

Subjects will be outfitted with the portable metabolic cart and oximeter as in the previous visit. One of two treadmill trials will be performed: 1) at the speed and 2) at the slope +speed determined in the previous visit. Trial order will be randomized among subjects and across visits 3 & 4. For each trial, subjects will be asked to walk on a treadmill for up to 6 minutes. Speed or slope will be increased every 30 seconds and they will be asked to walk for one minute at that speed or slope.

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra J. Romberger, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1I21RX003294-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

E3294-P

Identifier Type: -

Identifier Source: org_study_id