Clinical trial NCT04026529: Uphill Walking as Exercise for COPD Patients
Official title: Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Patients Through Uphill Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: pulmonary rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Nebraska
First posted: 2019-07-19
Enrollment: 8
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cross-sectional design
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Dyspnea
timeFrame: Visits were assessed at pre-specified randomized slope/speed treadmill intervals, with each visit scheduled to occur within one week of the previous visit, all taking place within a 6-week period following enrollment
Secondary outcomes:
Other outcomes:
measure: Dynamic Hyperinflation
timeFrame: Visits were assessed at pre-specified randomized slope/speed treadmill intervals, with each visit scheduled to occur within one week of the previous visit, all taking place within a 6-week period following enrollment
measure: Respiratory Rate
timeFrame: Visits were assessed at pre-specified randomized slope/speed treadmill intervals, with each visit scheduled to occur within one week of the previous visit, all taking place within a 6-week period following enrollment
measure: Percentage of Time in Which the Most Common Ratio of Coupling Was Detected
timeFrame: Visits were assessed at pre-specified randomized slope/speed treadmill intervals, with each visit scheduled to occur within one week of the previous visit, all taking place within a 6-week period following enrollment
measure: Oxygen Uptake
timeFrame: Visits were assessed at pre-specified randomized slope/speed treadmill intervals, with each visit scheduled to occur within one week of the previous visit, all taking place within a 6-week period following enrollment
measure: Lung Dead Space
timeFrame: Visits were assessed at pre-specified randomized slope/speed treadmill intervals, with each visit scheduled to occur within one week of the previous visit, all taking place within a 6-week period following enrollment
Locations:
city: Omaha
country: United States
facility: Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
state: Nebraska
Study officials:
affiliation: Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
name: Debra J. Romberger, MD
role: PRINCIPAL_INVESTIGATOR
References: