Thoracic Lymphatic Pump Techniques for Reducing Lung Volumes in Persons With Chronic Obstructive Pulmonary Disease

Not Applicable

Withdrawn

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT02030145
• Lead Sponsor: A.T. Still University of Health Sciences

Brief Summary

The primary goal of this line of research is to see if realistic manipulative protocols can be developed to produce sustained reductions in residual volume and improve pulmonary function parameters in people with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

This study is a prospective randomized crossover study to evaluate the effects of two different manipulation techniques on pulmonary function parameters in persons with COPD. Thirty-six (36) subjects will be enrolled in the study in order to complete the study with at least 30 subjects. Pulmonary function measures will include spirometry and lung volume. The pulmonary function testing will be done baseline, 30 minutes post-treatment, and 3 hours post-treatment. The study protocol treatment consists of a five-minute treatment session of one of the two studied treatment techniques given in a random order. After a washout period of at least four weeks, the subject will return for a second treatment session using the other technique.

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2011-07
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2014-01-07
• Last Update Submitted: 2014-01-07
• Study First Posted: 2014-01-08
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All subjects must be age 50 or older, have a history consistent with the diagnosis of COPD, and have documented airflow obstruction and an increased residual volume on pulmonary function testing. Airflow obstruction is defined as an FEV1/FVC ratio of 70 percent or less of the predicted value and a RV of 120 percent or greater of the predicted value.

Exclusion Criteria

Subjects will be excluded if they have received any form of manipulative treatment in the 3 months prior to enrolling in the study. Subjects with acute respiratory illness, such as an exacerbation of COPD, acute bronchitis, or pneumonia will be excluded from the study. Persons unable to cooperate and follow instructions to complete pulmonary function testing due to dementia or other cognitive disorders will be excluded as will persons with spinal scoliosis greater than 25 degrees, significant chest wall deformity, and acute rib or compression fracture of the vertebra, unstable angina, or unstable congestive heart failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pulmonary function tests	30 minutes and 3 hours post-treatment	Tests will be conducted by body plethysmography utilizing the MedGraphics® 1085 Series™ to measure changes in pulmonary function.

Trial Locations

Locations (1)

A.T. Still University of Health Sciences; 🇺🇸 Kirksville, Missouri, United States