Sustainability of Pulmonary Rehab Gains

NCT02241733 | Completed Results DMC

• 1 other identifier: O1325-R
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Keywords

exercise; pulmonary rehabilitation; dynamic hyperinflation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Inspiratory Capacity

  52 week test

• 6 Minute Walk Distance

  52 weeks

• Mastery Over Breathing

  52 weeks

Study Arms (2)

exercise

ACTIVE COMPARATOR

Patients will exercise for 12 weeks and then participate in an adherence program

Behavioral: Exercise only

exercise plus breathing retraining

EXPERIMENTAL

Patients will exercise plus breathing retraining for 12 weeks and then participate in an adherence program

Behavioral: Breathing retraining plus exercise

Interventions

Breathing retraining plus exercise BEHAVIORAL

Patients will participate in a 12-week exercise program with breathing retraining. They will also participate in an adherence program.

exercise plus breathing retraining

Exercise only BEHAVIORAL

Patients will participate in a 12-week exercise program . They will also participate in an adherence program.

exercise

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Eileen Collins RN, PhD, Research Nurse Scientist
• Organization: Edward Hines Jr., VA Hospital

ecollins@uic.edu

312-413-5621

Study Officials

• Eileen G. Collins, PhD RN

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 16, 2014
• Study Start: October 1, 2014
• Primary Completion: October 21, 2018
• Study Completion: August 12, 2019
• Last Updated: October 3, 2019
• Results First Posted: October 3, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)