Breathing Training for Asthma

NCT ID: NCT00975273

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-07-31

Brief Summary

For the proposed randomized controlled treatment study, the investigators plan to compare the effects of this hypoventilation-based breathing training with a control intervention that will focus on breathing regularity and awareness. The two therapeutic procedures are closely matched on important variables such as duration and the nature of patient-therapist interaction, monitoring asthma related status and the medication intake, use of scientific equipment and monitoring devices to increase adherence, and initial plausibility. Asthma patients who will be evaluated before, during, directly after, and at 2 months and 6 months after training.

Detailed Description

For this randomized controlled treatment study, the investigators plan to compare the effects of hypoventilation-based breathing training with a control intervention that will focus on breathing regularity and awareness. The two therapeutic procedures are closely matched on important variables such as duration and the nature of patient-therapist interaction, monitoring asthma related status and the medication intake, use of scientific equipment and monitoring devices to increase adherence, and initial plausibility. Asthma patients will be evaluated before, during, directly after, and at 1 month and 6 months after training. The primary goal of this training is to determine if a capnometry-assisted breathing training to raise end-tidal CO2 will produce more improvement in asthma control than a control training of breathing awareness. The second goal is to determine if capnometry-assisted breathing training for raising pCO2 will lead to higher pCO2 levels after training than before training on all three measures of pCO2 (the 2-hour monitoring, the standardized training sessions, and the homework assignments). The last objective is to determine if the clinical improvement in asthma outcomes for the raise-pCO2 breathing group will be greater in patients with more improvement in their pCO2.

Conditions

ASTHMA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Breathing Training

Patients will receive biofeedback assisted breathing training

Group Type: EXPERIMENTAL

Capnometry Assisted Respiration Training

Intervention Type: BEHAVIORAL

Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly, and shallowly in order to raise their PCO2 levels with the assistance of a biofeedback device.

Breathing Awareness

Patients will receive biofeedback assisted breathing awareness training.

Group Type: ACTIVE_COMPARATOR

Breathing Awareness

Intervention Type: BEHAVIORAL

Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly using a biofeedback device.

Interventions

Capnometry Assisted Respiration Training

Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly, and shallowly in order to raise their PCO2 levels with the assistance of a biofeedback device.

Intervention Type: BEHAVIORAL

Breathing Awareness

Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly using a biofeedback device.

Intervention Type: BEHAVIORAL

Other Intervention Names

CART

Eligibility Criteria

Inclusion Criteria

1. Men or women between 18 and 65 years of age

2. Understand and read english adequately

3. A previously documented history of asthma from intermittent to severe (symptoms plus objective documentation of at least partially reversible airflow obstruction)

4. Willing to undergo a 5-session course of breathing training

5. Current asthma symptoms

Exclusion Criteria

1. Clinically significant heart disease

2. Clinically significant cerebrovascular disease

3. Clinically significant thyroid dysfunction

4. Out-of-control diabetes

5. Use of oral corticosteroids in the last 3 months

6. Active smokers or more than 10 pack years

7. Clinically significant chronic obstructive pulmonary disease

8. Clinically significant emphysema

9. Current alcohol and substance dependence

10. Psychotic disorders and high risk for personality disorders

11. Having received previous breathing training exercises for asthma

12. Not willing to abstain from taking the morning dose of their long-term bronchodilator or leukotriene inhibitors or from using their short-acting beta-2 adrenergic agonists or anticholinergic bronchodilators for 8 hours before the pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up assessments (Medication withdrawal will be discouraged if patients should experience significant symptoms before the assessments. They will be offered to reschedule the appointment without any consequences for their enrollment in the study.)

13. Night shift workers

14. Tuberculosis

15. Pregnant, plan on becoming pregnant, or nursing during the course of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Baylor Health Care System

OTHER

Sponsor Role: collaborator

Southern Methodist University

OTHER

Sponsor Role: lead

Responsible Party

Alicia Meuret

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alicia Meuret, PhD

Role: PRINCIPAL_INVESTIGATOR

SMU

Thomas Ritz, PhD

Role: PRINCIPAL_INVESTIGATOR

SMU

Mark Millard, MD

Role: PRINCIPAL_INVESTIGATOR

BUMC

Locations

Baylor University Medical Center (BUMC)

Dallas, Texas, United States

Southern Methodist University (SMU)

Dallas, Texas, United States

Countries

United States

References

Meuret AE, Rosenfield D, Millard MM, Ritz T. Biofeedback Training to Increase P co2 in Asthma With Elevated Anxiety: A One-Stop Treatment of Both Conditions? Psychosom Med. 2023 Jun 1;85(5):440-448. doi: 10.1097/PSY.0000000000001188. Epub 2023 Mar 23.

Reference Type: DERIVED

PMID: 36961348 (View on PubMed)

Ritz T, Rosenfield D, Steele AM, Millard MW, Meuret AE. Controlling asthma by training of Capnometry-Assisted Hypoventilation (CATCH) vs slow breathing: a randomized controlled trial. Chest. 2014 Nov;146(5):1237-1247. doi: 10.1378/chest.14-0665.

Reference Type: DERIVED

PMID: 25122497 (View on PubMed)

Other Identifiers

SMU IRB:KS08-051

Identifier Type: -

Identifier Source: secondary_id

Baylor IRB: 001-180

Identifier Type: -

Identifier Source: secondary_id

5R01HL089761

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01HL89761-2

Identifier Type: -

Identifier Source: org_study_id