Uphill Walking as Exercise for COPD Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04026529|
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: walking on incline or walking at increasing speed||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cross-sectional design|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Patients Through Uphill Walking|
|Estimated Study Start Date :||December 2, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||November 30, 2021|
Experimental: walking at incline
Subjects will walk on treadmill at slope and speed to equal 70-80% 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,in addition to 89 markers on the thorax and abdomen.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
- Dyspnea [ Time Frame: within 6 weeks of 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
- Dynamic hyperinflation [ Time Frame: within 6 weeks of enrollment ]Dynamic hyperinflation will be assessed through opto-plethysmography, an established method of computing lung volumes, including dynamic hyperinflation. Opto-plethysmography uses three-dimensional motion capture information to determine lung volumes. The 3-D coordinates of the 89 markers on the abdomen and thorax will be used to create a representation of the surface of the trunk (Motion Analysis Corp., Santa Rosa, CA; 120Hz). The volume of the trunk enclosed by the surface will be obtained through a custom computer code (MathWorks, Inc., Natick, MA). Dynamic hyperinflation will be considered to be present when end-expiratory chest wall volume increased in relation to resting values.
- respiratory rate [ Time Frame: 7 days after the initial assessment ]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.
- Coupling [ Time Frame: within 14 days after initial assessment ]
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 marker position data will be analyzed using custom MATLAB code. Data will be plotted to detect spikes and outliers. Spikes and data points greater than three standard deviations from the mean will be removed. A cubic spline will be used to interpolate the removed data points. All marker data are then normalized to the unit vector for comparison.
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); it is usually counted in integer or half-integer ratios, measured using discrete relative phase. The range of ratios and the percentage of time each ratio is utilized will be recorded.
- oxygen uptake [ Time Frame: 7days after initial assessment ]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.
- lung dead space [ Time Frame: within 7 days of initial assessment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026529
|Contact: Debra J Romberger, MD||(402) 346-8800 ext 3542||Debra.Romberger@va.gov|
|United States, Nebraska|
|Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE||Not yet recruiting|
|Omaha, Nebraska, United States, 68105-1873|
|Contact: Frederick G Hamel 402-995-3032 Frederick.Hamel@va.gov|
|Contact: Wendy A Inselman (402) 346-8800 ext 3940 firstname.lastname@example.org|
|Principal Investigator: Debra J. Romberger, MD|
|Principal Investigator:||Debra J. Romberger, MD||Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE|