Uphill Walking as Exercise for COPD Patients

NCT04026529 | Completed Results DMC

• 2 other identifiers: E3294-P1I21RX003294-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (5)

• Dynamic Hyperinflation

  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

  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

  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

Study Arms (1)

walking at incline

EXPERIMENTAL

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

Interventions

walking on incline or walking at increasing speed 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.

walking at incline

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

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

Study Sites (1)

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

Omaha, Nebraska, 68105-1873, United States

Location

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

Limitations and Caveats

Study enrollment impacted by COVID-19

Results Point of Contact

• Title: Dr. Debra Romberger
• Organization: Omaha VA Medical Center

debra.romberger@va.gov

4025597539

Study Officials

• Debra J. Romberger, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Cross-sectional design

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 19, 2019
• Study Start: January 6, 2020
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2022
• Last Updated: August 30, 2024
• Results First Posted: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)