- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04260243
Myofascial Release in Patients With Chronic Obstructive Pulmonary Disease (MFR-COPD)
Effects of Myofascial Release in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MARÍA DOLORES ARGUISUELAS, PhD
- Phone Number: 64352 961369000
- Email: doloresarguisuelas@uchceu.es
Study Contact Backup
- Name: JUAN FRANCISCO L PÁRRAGA, PhD
- Phone Number: 618055092
- Email: juanfran@uchceu.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Study Chair: JUAN FRANCISCO L PÁRRAGA, Cardenal Herrera University
Publications and helpful links
General Publications
- Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary. Arch Bronconeumol. 2017 Mar;53(3):128-149. doi: 10.1016/j.arbres.2017.02.001. Epub 2017 Mar 6. Erratum In: Arch Bronconeumol. 2017 Jul;53(7):411-412. English, Spanish.
- Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNIVERSITY CARDENAL HERRERA-23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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