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Completed

NCT Number: NCT00637299

Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Fondazione Salvatore Maugeri

Montescano, Pavia, 27040, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients affected by COPD

Exclusion criteria

  • other diseases other than COPD

Treatment and study plan

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).

Other names: OMT+PR

sham osteopathic treatment (SOT+PR)

Other

Only soft manipulation was performed

Other names: SOT+PR

Primary outcomes

  1. Walking Ability

    Time frame: 4 weeks

    6 minutes walking test (6MWT)

Secondary outcomes

  1. Lung Function Test

    Time frame: 4 weeks

    residual volume (RV)

Sponsors and collaborators

Lead sponsor

Fondazione Salvatore Maugeri

Other

Registry information

Official study title

Osteopathic Treatment May Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 17, 2008
Registry last updated
Oct 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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