NCT04260243

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
6.1 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 5, 2020

Last Update Submit

February 10, 2025

Conditions

Copd

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 6 Minutes Walking Test

    3 weeks

Study Arms (2)

Sham Myofascial + Respiratory rehabilitation

SHAM COMPARATOR

Respiratory rehabilitation programme + sham Myofascial Release

Other: Sham Myofascial + Respiratory rehabilitation

Experimental-Myofascial + Respiratory rehabilitation

EXPERIMENTAL

Respiratory rehabilitation programme + Myofascial Release

Other: Experimental-Myofascial + Respiratory rehabilitation

Interventions

Experimental-Myofascial + Respiratory rehabilitationOTHER

6 sessions of: Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)

Experimental-Myofascial + Respiratory rehabilitation
Sham Myofascial + Respiratory rehabilitationOTHER

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

Sham Myofascial + Respiratory rehabilitation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 26386894BACKGROUND

  • 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: 28274597BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • JUAN FRANCISCO L PÁRRAGA

    Cardenal Herrera University

    STUDY CHAIR

Central Study Contacts

MARÍA DOLORES ARGUISUELAS, PhD

CONTACT

961369000doloresarguisuelas@uchceu.es

JUAN FRANCISCO L PÁRRAGA, PhD

CONTACT

618055092juanfran@uchceu.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physiotherapy

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 12, 2025

Record last verified: 2025-02