Clinical trial NCT01582958: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Osteopathic Manipulative Treatment
Pulmonary Function Tests
Biochemical Alterations
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2012-04-23
Enrollment: 45
Sex: ALL
Minimum age (years): 49
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change from baseline in spirometry at 6 weeks and 12 weeks
timeFrame: baseline, 6 weeks, 12 weeks
measure: Change from baseline in P100 at 6 weeks and 12 weeks
timeFrame: baseline, 6 weeks, 12 weeks
measure: Change from baseline in MIP (maximum inspiratory pressure) and MEP (maximum expiratory pressure)at 6 weeks and 12 weeks.
timeFrame: baseline, 6 weeks, 12 weeks
measure: Change from baseline in inspiratory capacity at 6 weeks and 12 weeks.
timeFrame: baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change from baseline in exercise tolerance at 6 weeks and 12 weeks.
timeFrame: baseline, 6 weeks, 12 weeks
measure: Change from baseline in dyspnea (shortness of breath) at 6 weeks and 12 weeks.
timeFrame: baseline, 6 weeks, 12 weeks
measure: Change from baseline in quality of life at 6 weeks and 12 weeks.
timeFrame: baseline, 6 weeks, 12 weeks
measure: Change from baseline in profiling of the plasma metabolome at 6 weeks and 12 weeks.
timeFrame: baseline, 6 weeks, 12 weeks
measure: Change from baseline in profiling of plasma proteins at 6weeks and 12 weeks.
timeFrame: baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Lansing
country: United States
facility: McClaren Greater Lansing
state: Michigan
Study officials:
affiliation: Michigan State University
name: Sherman Gorbis, DO
role: PRINCIPAL_INVESTIGATOR
References: