Uphill Walking as Exercise for COPD Patients

August 2, 2024 updated by: VA Office of Research and Development

Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Patients Through Uphill Walking

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68105-1873
        • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 80 years (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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: 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
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
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dynamic Hyperinflation
Time Frame: 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
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.
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
Respiratory Rate
Time Frame: 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
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.
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
Percentage of Time in Which the Most Common Ratio of Coupling Was Detected
Time Frame: 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

The laboratory is equipped with a 17-camera, digital motion capture system (Motion Analysis Corp., Santa Rosa, CA; 120Hz) to allow for collection of three-dimensional marker positions in real time.

The breathing cycle will be determined based on the movement of markers placed on the chest, while the gait cycles will be identified using locomotor data derived from heel markers, focusing on heel contact events.

Coupling 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).
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
Oxygen Uptake
Time Frame: 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
Heart rate and pulmonary gas exchange analysis will be recorded on a breath-by-breath basis. This will provide an accurate measure of pulmonary gas exchange, including oxygen uptake, i.e. VO2, . Steady-state VO2 while walking will be averaged and normalized to standing metabolic rate.
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
Lung Dead Space
Time Frame: 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
Dead space: Tidal volume and expired carbon dioxide will be measured using the same equipment as oxygen uptake above. Partial pressure of arterial carbon dioxide will be measured using a transcutaneous sensor.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Nebraska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Debra J. Romberger, MD, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E3294-P
  • 1I21RX003294-01 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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