Clinical trial NCT02030145: Thoracic Lymphatic Pump Techniques for Reducing Lung Volumes in Persons With Chronic Obstructive Pulmonary Disease
Official title: Thoracic Lymphatic Pump Techniques for Reducing Lung Volumes in Persons With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Pulmonary
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2014-01-08
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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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.

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Primary outcomes:
measure: Pulmonary function tests
timeFrame: 30 minutes and 3 hours post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kirksville
country: United States
facility: A.T. Still University of Health Sciences
state: Missouri
Study officials:
affiliation: A.T. Still University of Health Sciences
name: Donald R. Noll, D.O.
role: PRINCIPAL_INVESTIGATOR
References: