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The purpose of this trial is to verify if an osteopathic treatment added to usual pulmonary rehabilitation trial is able to improve the walking ability of COPD patients and if there is any influence on lung functionality.
The investigators decided to perform an osteopathic manipulative treatment (OMT) in a population of COPD patients. OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner to improve physiologic function and/or support homeostasis that has been altered by somatic dysfunction. Concerning the respiratory system, osteopathy considers a model that describes the interdependent functions among five body components as follows: 1: the inherent motility of the brain and spinal cord; 2: fluctuation of the cerebrospinal fluid; 3: mobility of the intracranial and intraspinal membranes; 4: articular mobility of the cranial bones; 5: the involuntary mobility of the sacrum between the ilia. This model is the so called primary respiratory mechanism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active osteopathic treatment (OMT+PR) | Active Comparator | The examination was performed by osteopathic practitioners with emphasis on the neuromusculoskeletal system including palpatory diagnosis for somatic dysfunction and viscerosomatic change, in the context of total patient care. The examination was concerned with range of motion of all parts of the body, performed with the patient in multiple positions to provide static and dynamic evaluation. |
|
| SOT + PR | Sham Comparator | Sham osteopathic treatment (manipulation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active osteopathic treatment (OMT+PR): Active Comparator | Other | The treatment was done once a week for 4 weeks and lasted 30 minutes.The examination was done according to the following scheme: anamnesis; physical examination (evaluation of the posture, palpation, tests for passive and active motion of areas linked to altered respiratory function); cranic-sacral evaluation (by means of a palpation of the cranic-sacral mechanism). |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Ability | 6 minutes walking test (6MWT) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Function Test | residual volume (RV) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ercole Zanotti, md | Fondazione Salvatore Maugeri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Salvatore Maugeri | Montescano | Pavia | 27040 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Osteopathic Treatment | OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner. |
| FG001 | Sham Osteopathic Treatment (Manipulation) | Sham Osteopathic Treatment was performed applying only soft manipulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Osteopathic Treatment | OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner. |
| BG001 | Sham Osteopathic Treatment (Manipulation) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Ability | 6 minutes walking test (6MWT) | Posted | Mean | Standard Deviation | meters | 4 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Osteopathic Treatment | OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ercole Zanotti | Fondazione Salvatore Maugeri | 39 385 247 | 324 | ercole.zanotti@fsm.it |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
|
| sham osteopathic treatment (SOT+PR) | Other | Only soft manipulation was performed |
|
|
Sham Osteopathic Treatment was performed applying only soft manipulation
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Lung Function Test | residual volume (RV) | Posted | Mean | Standard Deviation | liters | 4 weeks |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Sham Osteopathic Treatment (Manipulation) | Sham Osteopathic Treatment was performed applying only soft manipulation | 0 | 0 | 0 | 0 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |