Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
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.
Detailed description
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.
Interventions
OTHERActive osteopathic treatment (OMT+PR): Active Comparator
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).
OTHERsham osteopathic treatment (SOT+PR)
Only soft manipulation was performed
Sponsors
Fondazione Salvatore Maugeri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients affected by COPD
Exclusion criteria
* other diseases other than COPD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Ability | 4 weeks | 6 minutes walking test (6MWT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung Function Test | 4 weeks | residual volume (RV) |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Osteopathic Treatment OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner. | 10 |
| Sham Osteopathic Treatment (Manipulation) Sham Osteopathic Treatment was performed applying only soft manipulation | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Sham Osteopathic Treatment (Manipulation) | Active Osteopathic Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 2 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 8 Participants | 12 Participants |
| Age Continuous | 63.5 years STANDARD_DEVIATION 4.7 | 64.2 years STANDARD_DEVIATION 5.5 | 63.8 years STANDARD_DEVIATION 5.1 |
| Region of Enrollment Italy | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Walking Ability
6 minutes walking test (6MWT)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Osteopathic Treatment | Walking Ability | 369.5 meters | Standard Deviation 80 |
| Sham Osteopathic Treatment (Manipulation) | Walking Ability | 304.7 meters | Standard Deviation 96.6 |
p-value: <0.01t-test, 1 sided
Secondary
Lung Function Test
residual volume (RV)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Osteopathic Treatment | Lung Function Test | 3.09 liters | Standard Deviation 1.7 |
| Sham Osteopathic Treatment (Manipulation) | Lung Function Test | 4.23 liters | Standard Deviation 1.4 |
p-value: <0.05t-test, 1 sided