Myofascial Release in Patients With Chronic Obstructive Pulmonary Disease (MFR-COPD)

November 17, 2023 updated by: ARGUISUELAS MARTINEZ MARÍA DOLORES, Cardenal Herrera University

Effects of Myofascial Release in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial

The main objective of this study is to assess the effects of a myofascial release protocol in patients with chronic obstructive pulmonary disease (COPD).

Study Overview

Detailed Description

So far, there are no previous studies that analyze the effects of a myofascial relaxation protocol applied to the diaphragm within the respiratory rehabilitation treatment in patients with chronic obstructive pulmonary disease.

Aim: The main objective of this study is to assess the effects of a 3 weeks myofascial release protocol applied to the diaphragm on respiratory parameters in patients with chronic obstructive pulmonary disease.

Design: Randomized clinical trial

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • COPD;
  • Forced expiratory volume in the first second (FEV1) < 80%;
  • FEV1/Forced vital capacity (FVC) < 70%;
  • Maximal inspiratory pressure (MIP) < 70%.

Exclusion Criteria:

  • Recent (6 months) spine or abdominal surgery;
  • Allergic status of any kind;
  • systemic diseases (rheumatic, infectious conditions, febrile state, vascular alterations, endocrine diseases including diabetes, metabolic, and neoplastic syndromes);
  • neuromuscular or neurological injuries;
  • previous myofascial release treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Myofascial + Respiratory rehabilitation
Respiratory rehabilitation programme + sham Myofascial Release
6 sessions of: Sham Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)
Experimental: Experimental-Myofascial + Respiratory rehabilitation
Respiratory rehabilitation programme + Myofascial Release
6 sessions of: Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life measured with the Chronic Obstructive Pulmonary Disease Assessment Test: Score
Time Frame: 3 weeks
Score (0-40) higher scores mean a worse outcome.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minutes Walking Test
Time Frame: 3 weeks
Maximum distance reached
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: JUAN FRANCISCO L PÁRRAGA, Cardenal Herrera University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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