Sustainability of Pulmonary Rehab Gains

COPD Clinical Trial

Official title:

Sustainability of Rehabilitation Gains in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241733
• Other study ID #: O1325-R
• Status: Completed
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: August 12, 2019

Study information

• Verified date: September 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

People with moderate to severe COPD trap air in their lungs. This lessens their ability to exercise. The investigators developed a computerized breathing retraining program to help patients empty their lungs during exercise. The investigators believe that learning to control breathing will help patients be more active. The purpose of this study is to test the effects of using breathing retraining (intervention group) versus no breathing retraining (control group) as part of a 12-week exercise program. The investigators are examining the long term effects of this training on exercise capacity and the ability to empty ones lungs during exercise. Patients will participate in a 12-week exercise program, with or without breathing retraining. They will then participate in a 42 week adherence program to maintain physical activity. Patient testing will be competed at baseline, 12 weeks, 6 months and 1 year. 250 patients with moderate to severe COPD will be enrolled.

Description:

Rationale: Development of dynamic hyperinflation is a primary limiting factor of exercise tolerance in chronic obstructive pulmonary disease (COPD). To lessen the development of dynamic hyperinflation, and to improve exercise tolerance in COPD patients, the investigators have developed a breathing-retraining technique to be used during pulmonary rehabilitation. This breathing-retraining technique is designed to decrease respiratory rate and prolong exhalation. The investigators demonstrated that, in the short-term, hyperinflation and exercise duration improved more with breathing-retraining plus exercise-training than with exercise-training alone. Because a crucial aspect of pulmonary rehabilitation is the maintenance its short-term benefits over the long-term, the investigators now propose to test whether short-term benefits of breathing-retraining plus exercise followed by an adherence-intervention program are sustainable over the long-term Primary Hypothesis: (H1) In COPD patients, improvements in exercise duration on a constant- load treadmill test will be greater after 12 weeks of breathing-retraining plus exercise-training followed by a 42-week adherence-intervention program (1 yr. total) than after 12 weeks of exercise-training alone followed by a 42-week adherence-intervention program (1 yr. total). Secondary Hypotheses: One year after randomization, exercise-induced dynamic hyperinflation will be less during a constant-load treadmill test (H2), 6-minute walking distance will be longer (H3), and mastery over breathing will be greater (H4) in the breathing-retraining plus exercise-training group than in the exercise-alone group. Lastly (exploratory objective), the investigators will assess the effect of the patient's physiologic, psychologic and clinical phenotype on short- term and long-term responsiveness to pulmonary rehabilitation.

Methods: The proposed study is a randomized, controlled clinical trial in which 250 patients with moderate-to-severe COPD will be enrolled. One hundred forty of these patients are expected to qualify for randomization into the breathing-retraining plus exercise-training group or the exercise-training alone group. Patients will receive 12-weeks of supervised training according to group assignment (three times weekly) followed by an adherence-intervention program (weekly phone motivational interviews, home-exercise program, and monthly laboratory booster sessions). Follow-up testing will be completed at 12 weeks, and at 6 and 12 months. Testing will include pulmonary function test, incremental-load and constant-load treadmill tests, 6-minute walk test, measurements of dyspnea, assessment of respiratory and quadriceps muscle strength and endurance and quadriceps ultrasonography. Analysis: In the principal analysis of the primary outcome measure (exercise duration; H1) the investigators will compare changes in exercise duration (constant work-rate treadmill test) from baseline to end of study using 2-sample t-test (two-tailed =.05). The primary analysis will be based on intention-to-treat principles. Multiple imputation will be used for study subjects missing the 12-month measurement. This imputation model will be based on baseline characteristics of study participants. Several secondary analyses of the primary outcome measure will be performed (H2-H4). Linear regression will be used to determine whether the observed treatment benefits persist after adjustment for baseline covariates and measures of adherence to treatment. Since several measurements will be taken on each patient, mixed-models analysis will be used to compare the changes on the constant-load treadmill test over time between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 12, 2019
• Est. primary completion date: October 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• >/= 40 yrs

• FEV1 </= 70% predicted

• FEV1/FVC <70% predicted

• RV/TLC >/=120%

• SpO2 >/= 90% at peak exercise (with or without exercise)

• inspiratory capacity decline >.15L from rest to peak exercise

Exclusion Criteria:

• respiratory infection/exacerbation within the previous 4 weeks

• exercise limiting heart disease

• primary asthma

• congestive heart failure

• exercise limiting peripheral arterial disease

• stops exercise due to arthritic pain in the knee or hips

• inability to walk on the treadmill

• pregnancy

• methadone use

• any unforeseen illness or disability that would preclude exercise testing or training

• participation in a formal exercise program within the previous 12 weeks

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Breathing retraining plus exercise
Patients will participate in a 12-week exercise program with breathing retraining. They will also participate in an adherence program.
• Exercise only
Patients will participate in a 12-week exercise program . They will also participate in an adherence program.

Locations

Country	Name	City	State
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Exercise Time on a Constant Work-rate Treadmill Test	Patients walk on a treadmill set at a constant workrate. The difference in the time walked on the treadmill from baseline to study completion is the primary outcome measure.	52 week test
Secondary	Inspiratory Capacity	Inspiratory capacity is measured at a set time during the constant workrate treadmill test. The difference between the inspiratory capacity measured at baseline and 52 weeks is a secondary outcome. Inspiratory capacity measured during exercise is a measure of dynamic hyperinflation.	52 week test
Secondary	6 Minute Walk Distance	Six-minute walk distance will be measured at 52 weeks. The difference in distance walked in meters between baseline and 52 weeks is the secondary outcome measure. The 6 minute walk is conducted using the guidelines issued by the American Thoracic Society.	52 weeks
Secondary	Mastery Over Breathing	Mastery over breathing is measured using the Chronic Respiratory Disease Questionnaire. Specifically the subscale 'mastery" is the investigators' secondary outcome. The difference in scores from baseline to 52 weeks is the investigators' outcome measure. The Chronic Respiratory Disease Questionnaire is a valid and reliable questionnaire. 1=minimum score, 7=maximum with the higher score indicating greater mastery. A higher score indicates better health. A change of 0.5 indicates a small change, 1.0 indicates a moderate change and greater or equal to a change of 1.5 indicates a large change.	52 weeks