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The Effect of OMT on Patients With COPD: Correlating Pulmonary Function Tests With Biochemical Alterations

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment (OMT)
sham omt
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Osteopathic Manipulative Treatment, Pulmonary Function Tests, Biochemical Alterations

Eligibility Criteria

49 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • postbronchodilator FEV1/FVC <0.7 and FEV1 <80% predicted [FEV1 =volume that has been exhaled at the end of the first second of forced expiration] and FVC volume of air that can be forcibly blown out after full inspiration]
  • history of smoking >20 pack-years
  • stable condition at inclusion with no infection or exacerbation for at least two months
  • optimal medical therapy for at least eight weeks with no change

Exclusion Criteria:

  • history of active pulmonary disease such as asthma
  • positive bronchodilator test
  • treatment with N-acetylcysteine
  • previous diagnosis of hypertension or current anti-hypertensive treatment
  • known unstable or moderate to severe heart disease (arrhythmia, ischemic heart disease, or cardiomyopathy)
  • previous diagnosis of chronic illness such as diabetes, renal failure, hypercholesterolemia, hepatic cirrhosis, cancer, rheumatoid arthritis or any other systemic inflammatory disease
  • neuromuscular or disabling cognitive problems
  • engagement in any exercise-training program during the past three months
  • substance abuse in the preceding six months

Sites / Locations

  • McClaren Greater Lansing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Treatment

placebo

Control

Arm Description

This arm will receive the usual Pulmonary Rehabilitation Program plus OMT, the intervention.

Receives normal pulmonary rehabilitation care plus positioned to receive OMT but OMT is not provided.

This arm receives only pulmonary rehabilitation care.

Outcomes

Primary Outcome Measures

Change from baseline in spirometry at 6 weeks and 12 weeks
amount (volume) and/or speed (flow) of air that can be inhaled and exhaled
Change from baseline in P100 at 6 weeks and 12 weeks
an index of diaphragm and inspiratory muscle efficiency (endurance)
Change from baseline in MIP (maximum inspiratory pressure) and MEP (maximum expiratory pressure)at 6 weeks and 12 weeks.
assessments of inspiratory and expiratory muscle function, respectively
Change from baseline in inspiratory capacity at 6 weeks and 12 weeks.
representing an indirect evaluation of chest wall excursion

Secondary Outcome Measures

Change from baseline in exercise tolerance at 6 weeks and 12 weeks.
6-minute walk test
Change from baseline in dyspnea (shortness of breath) at 6 weeks and 12 weeks.
shortness of breath questionnaire
Change from baseline in quality of life at 6 weeks and 12 weeks.
Short Form 36 questionnaire
Change from baseline in profiling of the plasma metabolome at 6 weeks and 12 weeks.
mass spectrometry (both non-targeted profiling of entire suite of metabolites and targeted profiling of oxylipins and endocannabinoid metabolites
Change from baseline in profiling of plasma proteins at 6weeks and 12 weeks.
antibody microarray analysis (particularly targeting the inflammatory/anti-inflammatory cytokines)

Full Information

First Posted
April 14, 2012
Last Updated
October 6, 2015
Sponsor
Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT01582958
Brief Title
The Effect of OMT on Patients With COPD: Correlating Pulmonary Function Tests With Biochemical Alterations
Official Title
The Effect of Osteopathic Manipulative Treatment on Patients With Chronic Obstructive Pulmonary Disease:Correlating Pulmonary Function Tests With Biochemical Alterations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This project proposes to test the hypothesis that osteopathic manipulative treatment (OMT) given to patients with moderate to severe chronic obstructive pulmonary disease (COPD) enrolled in a 12-week pulmonary rehabilitation program (PRP) will result in improved respiratory pump function over and above that seen in sham and control groups. Specifically, we will study the effects of three OMT techniques: (a) thoracic inlet indirect myofascial release; (b) rib raising with continued stretch of the paraspinal muscle to the L2 level; and (c) cervical paraspinal muscle stretch with suboccipital muscle release. The key clinical readouts will include: spirometry, P100 (and index of diaphragm and inspiratory muscle efficiency), maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), as well as laser evaluation of chest wall excursion. Supplementing these objective parameters will be several more subjective clinical outcome measures: exercise tolerance (6-minute walk test), dyspnea (shortness of breath questionnaire), and quality of life questionnaire. Finally, an attempt will be made to correlate biochemical alterations that may shed light on the biological mechanism underlying the OMT procedures.
Detailed Description
According to the above directions (provide a more extensice description, if desired), I am choosing to just submit the brief summary. Thank you, Sherman Gorbis, DO

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Osteopathic Manipulative Treatment, Pulmonary Function Tests, Biochemical Alterations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
This arm will receive the usual Pulmonary Rehabilitation Program plus OMT, the intervention.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Receives normal pulmonary rehabilitation care plus positioned to receive OMT but OMT is not provided.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm receives only pulmonary rehabilitation care.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Treatment (OMT)
Other Intervention Name(s)
Other names are not applicable.
Intervention Description
Osteopathic Manipulative Treatment (OMT) is the therapeutic application of manually guided forces by an Osteopathic physician to improve physiologic function.
Intervention Type
Other
Intervention Name(s)
sham omt
Other Intervention Name(s)
Other names are not applicable.
Intervention Description
Hands are placed on subjects the same as omt arm but no omt is provided.
Primary Outcome Measure Information:
Title
Change from baseline in spirometry at 6 weeks and 12 weeks
Description
amount (volume) and/or speed (flow) of air that can be inhaled and exhaled
Time Frame
baseline, 6 weeks, 12 weeks
Title
Change from baseline in P100 at 6 weeks and 12 weeks
Description
an index of diaphragm and inspiratory muscle efficiency (endurance)
Time Frame
baseline, 6 weeks, 12 weeks
Title
Change from baseline in MIP (maximum inspiratory pressure) and MEP (maximum expiratory pressure)at 6 weeks and 12 weeks.
Description
assessments of inspiratory and expiratory muscle function, respectively
Time Frame
baseline, 6 weeks, 12 weeks
Title
Change from baseline in inspiratory capacity at 6 weeks and 12 weeks.
Description
representing an indirect evaluation of chest wall excursion
Time Frame
baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in exercise tolerance at 6 weeks and 12 weeks.
Description
6-minute walk test
Time Frame
baseline, 6 weeks, 12 weeks
Title
Change from baseline in dyspnea (shortness of breath) at 6 weeks and 12 weeks.
Description
shortness of breath questionnaire
Time Frame
baseline, 6 weeks, 12 weeks
Title
Change from baseline in quality of life at 6 weeks and 12 weeks.
Description
Short Form 36 questionnaire
Time Frame
baseline, 6 weeks, 12 weeks
Title
Change from baseline in profiling of the plasma metabolome at 6 weeks and 12 weeks.
Description
mass spectrometry (both non-targeted profiling of entire suite of metabolites and targeted profiling of oxylipins and endocannabinoid metabolites
Time Frame
baseline, 6 weeks, 12 weeks
Title
Change from baseline in profiling of plasma proteins at 6weeks and 12 weeks.
Description
antibody microarray analysis (particularly targeting the inflammatory/anti-inflammatory cytokines)
Time Frame
baseline, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: postbronchodilator FEV1/FVC <0.7 and FEV1 <80% predicted [FEV1 =volume that has been exhaled at the end of the first second of forced expiration] and FVC volume of air that can be forcibly blown out after full inspiration] history of smoking >20 pack-years stable condition at inclusion with no infection or exacerbation for at least two months optimal medical therapy for at least eight weeks with no change Exclusion Criteria: history of active pulmonary disease such as asthma positive bronchodilator test treatment with N-acetylcysteine previous diagnosis of hypertension or current anti-hypertensive treatment known unstable or moderate to severe heart disease (arrhythmia, ischemic heart disease, or cardiomyopathy) previous diagnosis of chronic illness such as diabetes, renal failure, hypercholesterolemia, hepatic cirrhosis, cancer, rheumatoid arthritis or any other systemic inflammatory disease neuromuscular or disabling cognitive problems engagement in any exercise-training program during the past three months substance abuse in the preceding six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherman Gorbis, DO
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McClaren Greater Lansing
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States

12. IPD Sharing Statement

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The Effect of OMT on Patients With COPD: Correlating Pulmonary Function Tests With Biochemical Alterations

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