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Effect of Ventilation-Feedback Training on Exercise Performance in COPD
This study has been completed.
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00037973
  Purpose

The primary objective of the study is to determine whether individuals with Chronic Obstructive Pulmonary Disease (COPD) who complete ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength program will demonstrate significantly longer exercise duration on a constant work rate treadmill 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 ventilation-feedback only. Secondary study objectives are to determine whether individuals with COPD who complete ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training program will demonstrate significantly: (a) greater exercise tolerance and aerobic power; (b) lower perception of breathlessness during progressive and constant work rate leg-cycle and treadmill exercise testing; (c) higher tidal volume and lower breathing frequency during constant work rate and at any given workload during progressive testing; (d) lower score on the Chronic Respiratory Disease Questionnaire indicating improved quality of life; (e) higher transition focal score (less dyspnea) on the Transition Dyspnea Index; (f) maintain a sustained breathing-pattern adjustment to exercise when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength program without ventilation-feedback or ventilation-feedback only.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Behavioral: Training
Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Effects of Ventilation-Feedback Training on Exercise Performance in COPD

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 108
Study Start Date: August 2000
Study Completion Date: August 2003
Detailed Description:

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.

Specific Objectives:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients with chronic obstructive pulmonary disease

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037973

Locations
United States, Illinois
VAMC
Hines, Illinois, United States
Sponsors and Collaborators
Investigators
Study Director: David Wolff, Special Assistant to the Director, Ph.D. Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service
Investigator: Vicki Mongiardo, Program Analyst Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
  More Information

Publications indexed to this study:
Study ID Numbers: F2302
Study First Received: May 24, 2002
Last Updated: December 11, 2007
ClinicalTrials.gov Identifier: NCT00037973  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Ventilation
COPD

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009