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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04260243
Other study ID # UNIVERSITY CARDENAL HERRERA-23
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date June 2025

Study information

Verified date November 2023
Source Cardenal Herrera University
Contact MARÍA DOLORES ARGUISUELAS, PhD
Phone 961369000
Email doloresarguisuelas@uchceu.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cardenal Herrera University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life measured with the Chronic Obstructive Pulmonary Disease Assessment Test: Score Score (0-40) higher scores mean a worse outcome. 3 weeks
Secondary 6 Minutes Walking Test Maximum distance reached 3 weeks
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