Effect of Ventilation-Feedback Training on Exercise Performance in COPD
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|ClinicalTrials.gov Identifier: NCT00037973|
Recruitment Status : Completed
First Posted : May 27, 2002
Last Update Posted : September 16, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Behavioral: ventilation feedback Behavioral: exercise||Phase 2|
Statement of the Problem: Chronic obstructive pulmonary disease (COPD) is a term used to characterize those individuals with chronic bronchitis or emphysema who have obstruction to airflow on a spirogram. 1) Patients with COPD have a poor exercise capacity that is reflective of their underlying disease. 2) The symptoms of lung disease triggered by simple low-intensity activities of daily living such as dressing and undressing, bathing and shopping are insufferable, consequently these patients become sedentary. An increasingly sedentary lifestyle leads to muscle deconditioning making physical activity even more intolerable. 3) The cycle continues in a downward spiral. Pulmonary rehabilitation is essential to assist persons with COPD to cope with their disease. The two primary objectives of pulmonary rehabilitation are to control and alleviate the symptoms of the respiratory illness and to assist the patient toward optimal capabilities in carrying out his/her activities of daily living. 4) The proposed study will evaluate the efficacy of a unique program of ventilation-feedback training combined with leg-cycle and walking exercise to improve exertional endurance, perceived dyspnea and quality of life in persons with COPD.
Hypothesis: Individuals with COPD who complete 12-weeks of ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training program will demonstrate significantly longer exercise duration on the treadmill constant work rate (CWR) exercise test when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training or a ventilation-feedback training only program.
Short-term Objectives- The primary objective of the proposed study is to determine whether individuals with COPD who complete 12-weeks of ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training program will demonstrate significantly longer exercise duration on the treadmill CWR exercise test when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training program without ventilation-feedback or a ventilation-feedback program only. The secondary objectives of the proposed research are to determine whether individuals with COPD who complete ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training or ventilation-feedback only program will, when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training program only, demonstrate significantly: (a) greater work tolerance and aerobic power on maximal leg-cycle and treadmill exercise tests; (b) lower perception of breathlessness during progressive and CWR leg-cycle and treadmill exercise tests; (c) significantly higher tidal volume (VT) and lower breathing frequency during CWR and at any given workload on the progressive leg-cycle and treadmill exercise tests; (d) lower score on the Chronic Respiratory Disease Questionnaire (CRDQ)5 indicating better quality of life; and (e) higher transition focal score on the Transition Dyspnea Index (TDI).6 In addition, six weeks after completing the training program all subjects will repeat the treadmill CWR test. This will be done to assess whether the positive effects of the ventilation-feedback training persist beyond the 12-week training period.
Long-term Objectives: If our hypothesis is correct, we will use the ventilation-feedback technique to teach a more efficient breathing pattern during activities of daily living. In time, the system will be miniaturized and portable thereby making this new technique readily usable during pulmonary rehabilitation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Ventilation-Feedback Training on Exercise Performance in COPD|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||August 2003|
|Actual Study Completion Date :||August 2003|
Ventilation-feedback plus exercise
|Behavioral: ventilation feedback Behavioral: exercise|
Active Comparator: 2
Active Comparator: 3
ventilation feedback only
|Behavioral: ventilation feedback|
- Exercise endurance [ Time Frame: 12 weeks ]
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): NCT00037973
|United States, Illinois|
|Edward Hines, Jr. VA Hospital|
|Hines, Illinois, United States, 60141-5000|
|Principal Investigator:||Eileen G. Collins, PhD RN||Edward Hines Jr. VA Hospital|