Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease

NCT01633697 | Completed DMC

• 2 other identifiers: M12-1311R34HL113290-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators hypothesize that education will improve exercise capacity, symptoms and quality of life in patients with chronic obstructive pulmonary disease (COPD). In addition, the investigators are interested in determining how education might alter various chemicals in the blood and exhaled breath that reflect inflammation in the lungs and the body as a whole. The investigators plan to enroll 42 patients into this study, with half of them participating at each of the two sites, Vermont Lung Center at the University of Vermont in Burlington, Vermont, and at Baylor College of Medicine in Houston, Texas. Participants will undergo a series of measurements and tests at the beginning of the study, receive formal education about COPD over the next 2 weeks, return at 6 weeks for a brief refresher session, and finally return after 12 weeks for repeat measurement and testing as was done at the beginning. Participants will be asked to keep a diary of symptoms, medication, and exercise during the study.

Conditions

COPD

Keywords

emphysema; chronic bronchitis

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance

  Exercise tolerance will be measured by 6 min walk distance at baseline and again after 12 weeks of the intervention

  12 weeks

Secondary Outcomes (6)

• Dynamic hyperinflation

  12 weeks

• Oxidative stress

  12 weeks

• Systemic inflammation

  12 weeks

• Lung mechanics

  12 weeks

• Dyspnea

  12 weeks

Study Arms (2)

Education-Pranayama

EXPERIMENTAL

Subjects will receive education about COPD with special attention to breathing techniques

Behavioral: Pranayama

Education-Control

SHAM COMPARATOR

Subjects will receive education alone about COPD.

Behavioral: Education alone

Interventions

Pranayama BEHAVIORAL

Specific yoga-related breathing method.

Also known as: Dirgha 3-Part Breathing method

Education-Pranayama

Education alone BEHAVIORAL

No special attention to breathing

Education-Control

Eligibility Criteria

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

You may qualify if:

• Men and women, aged 18 and older, with a physician diagnosis of COPD
• COPD defined according to GOLD criteria, with FEV1/FVC \< 0.7, and FEV1 \< 80% predicted.
• Current non-smoker
• Stable medical regimen for COPD over last 4 weeks
• Stable physical activity over the last 4 weeks, with no plans for any change during the duration of the study
• MRC Dyspnea Scale \> 2
• Not planning to engage in any formal pulmonary rehabilitation program during the time of the study
• No use of any nutritional supplements other than standard multivitamins

You may not qualify if:

• Exacerbation of disease within previous 2 weeks
• Concomitant other respiratory disease or significant cardiovascular disease
• Previous practice of yoga
• Current use of antioxidant supplements (e.g., vitamin C, vitamin E, n-acetylcysteine)

Sponsors & Collaborators

• University of Vermont: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Vermont Lung Center

Colchester, Vermont, 05446, United States

Location

Related Links

• Vermont Lung Center

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• David Kaminsky, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 4, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: October 1, 2016
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (2)