Myofascial Release in Patients with Chronic Obstructive Pulmonary Disease

NCT04260243 — Not applicable, Not yet recruiting, 30 participants, Cardenal Herrera University

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

Registry	NCT04260243, acronym MFR-COPD
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	30 (Estimated)
Sponsor	Cardenal Herrera University (Other)
Conditions	Copd
Interventions	Experimental-Myofascial + Respiratory rehabilitation, Sham Myofascial + Respiratory rehabilitation (Other)
Dates	start 2026-03-01 (estimated), primary completion 2027-03-01 (estimated), completion 2027-06-01 (estimated), first posted 2020-02-07, last updated 2025-02-12

-Summary

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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Sham Myofascial + Respiratory rehabilitation	Sham comparator	Other: Sham Myofascial + Respiratory rehabilitation	Respiratory rehabilitation programme + sham Myofascial Release
Experimental-Myofascial + Respiratory rehabilitation	Experimental	Other: Experimental-Myofascial + Respiratory rehabilitation	Respiratory rehabilitation programme + Myofascial Release

Experimental-Myofascial + Respiratory rehabilitation (Other): 6 sessions of: Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)
Sham Myofascial + Respiratory rehabilitation (Other): 6 sessions of: Sham Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)

+Outcome measures

Primary outcomes

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

Secondary outcomes

6 Minutes Walking Test [3 weeks]: Maximum distance reached

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.

+Publications

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. PMID 26386894
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. English, Spanish. PMID 28274597

+Investigators

JUAN FRANCISCO L PÁRRAGA, Study chair, Cardenal Herrera University