Back to resultsThoracic Lymphatic Pump Techniques for Reducing Lung Volumes in Persons With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compressive Thoracic Lymphatic Pump
Classic Thoracic Lymphatic Pump
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Pulmonary
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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Sites / Locations
- A.T. Still University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Classic Thoracic Lymphatic Pump
Compressive Thoracic Lymphatic Pump
Arm Description
Subjects begin with Classic Thoracic Lymphatic Pump, then crossover to Compressive Thoracic Lymphatic Pump after 4-week washout period.
Subjects begin with Compressive Thoracic Lymphatic Pump, then crossover to Classic Thoracic Lymphatic Pump after 4-week washout period.
Outcomes
Primary Outcome Measures
Pulmonary function tests
Tests will be conducted by body plethysmography utilizing the MedGraphics® 1085 Series™ to measure changes in pulmonary function.
Secondary Outcome Measures
Full Information
NCT ID
NCT02030145
First Posted
July 22, 2011
Last Updated
January 7, 2014
Sponsor
A.T. Still University of Health Sciences
Collaborators
American Osteopathic Association
1. Study Identification
Unique Protocol Identification Number
NCT02030145
Brief Title
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
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Withdrawn
Why Stopped
PI relocated
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A.T. Still University of Health Sciences
Collaborators
American Osteopathic Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Pulmonary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Classic Thoracic Lymphatic Pump
Arm Type
Active Comparator
Arm Description
Subjects begin with Classic Thoracic Lymphatic Pump, then crossover to Compressive Thoracic Lymphatic Pump after 4-week washout period.
Arm Title
Compressive Thoracic Lymphatic Pump
Arm Type
Experimental
Arm Description
Subjects begin with Compressive Thoracic Lymphatic Pump, then crossover to Classic Thoracic Lymphatic Pump after 4-week washout period.
Intervention Type
Procedure
Intervention Name(s)
Compressive Thoracic Lymphatic Pump
Other Intervention Name(s)
Modified TLP
Intervention Description
This technique is a modification of the Classic Thoracic Lymphatic Pump where some pressure is maintained on the chest wall at the end of each exhalation and at the end of the third or fourth breathing cycle, during the inhalation phase, the hands are slowly removed from the chest wall, gradually releasing pressure on the chest without causing a sudden change in intrathoracic pressures.
Intervention Type
Procedure
Intervention Name(s)
Classic Thoracic Lymphatic Pump
Other Intervention Name(s)
TLP
Intervention Description
This technique is well described in Chapter 68 of the Foundations for Osteopathic Medicine, 2nd Edition.
Primary Outcome Measure Information:
Title
Pulmonary function tests
Description
Tests will be conducted by body plethysmography utilizing the MedGraphics® 1085 Series™ to measure changes in pulmonary function.
Time Frame
30 minutes and 3 hours post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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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Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald R. Noll, D.O.
Organizational Affiliation
A.T. Still University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.T. Still University of Health Sciences
City
Kirksville
State/Province
Missouri
ZIP/Postal Code
63501
Country
United States
12. IPD Sharing Statement
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Thoracic Lymphatic Pump Techniques for Reducing Lung Volumes in Persons With Chronic Obstructive Pulmonary Disease
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