Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial

NCT00637299 | Completed Early Phase 1 Results

• 1 other identifier: 01/2008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Walking Ability

  6 minutes walking test (6MWT)

  4 weeks

Secondary Outcomes (1)

• Lung Function Test

  4 weeks

Study Arms (2)

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.

Other: Active osteopathic treatment (OMT+PR): Active Comparator

SOT + PR

SHAM COMPARATOR

Sham osteopathic treatment (manipulation)

Other: sham osteopathic treatment (SOT+PR)

Interventions

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).

Also known as: OMT+PR

Active osteopathic treatment (OMT+PR)

sham osteopathic treatment (SOT+PR) OTHER

Only soft manipulation was performed

Also known as: SOT+PR

SOT + PR

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients affected by COPD

You may not qualify if:

• other diseases other than COPD

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (1)

Fondazione Salvatore Maugeri

Montescano, Pavia, 27040, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ercole Zanotti
• Organization: Fondazione Salvatore Maugeri

ercole.zanotti@fsm.it

39 385 247

Study Officials

• Ercole Zanotti, md

  Fondazione Salvatore Maugeri

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 24, 2011
• Results First Posted: April 20, 2009

Record last verified: 2011-10

Locations

IT (1)