NCT02030145

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
Last Updated

January 8, 2014

Status Verified

July 1, 2011

Enrollment Period

1 year

First QC Date

July 22, 2011

Last Update Submit

January 7, 2014

Conditions

Keywords

COPDPulmonary

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function tests

    Tests will be conducted by body plethysmography utilizing the MedGraphics® 1085 Series™ to measure changes in pulmonary function.

    30 minutes and 3 hours post-treatment

Study Arms (2)

Classic Thoracic Lymphatic Pump

ACTIVE COMPARATOR

Subjects begin with Classic Thoracic Lymphatic Pump, then crossover to Compressive Thoracic Lymphatic Pump after 4-week washout period.

Procedure: Compressive Thoracic Lymphatic PumpProcedure: Classic Thoracic Lymphatic Pump

Compressive Thoracic Lymphatic Pump

EXPERIMENTAL

Subjects begin with Compressive Thoracic Lymphatic Pump, then crossover to Classic Thoracic Lymphatic Pump after 4-week washout period.

Procedure: Compressive Thoracic Lymphatic PumpProcedure: Classic Thoracic Lymphatic Pump

Interventions

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.

Also known as: Modified TLP
Classic Thoracic Lymphatic PumpCompressive Thoracic Lymphatic Pump

This technique is well described in Chapter 68 of the Foundations for Osteopathic Medicine, 2nd Edition.

Also known as: TLP
Classic Thoracic Lymphatic PumpCompressive Thoracic Lymphatic Pump

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.T. Still University of Health Sciences

Kirksville, Missouri, 63501, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Donald R. Noll, D.O.

    A.T. Still University of Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2011

First Posted

January 8, 2014

Study Start

February 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

January 8, 2014

Record last verified: 2011-07

Locations