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Not yet recruitingNCT04260243MFR-COPDUpdated Feb 12, 2025

Myofascial Release in Patients with Chronic Obstructive Pulmonary Disease

An interventional study of Experimental-Myofascial + Respiratory rehabilitation and Sham Myofascial + Respiratory rehabilitation in Copd, sponsored by Cardenal Herrera University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the 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

02

Conditions studied

  • Copd
03

In context

Pulmonary Disease, Chronic Obstructive

5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.

This study's planned enrollment of 30 is below the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Cardenal Herrera University is the lead sponsor of 108 studies on the registry; 22 are open to participants now.

Browse Cardenal Herrera University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ;
  • (FEV1) \< 80%;
  • FEV1/Forced vital capacity (FVC) \< 70%;
  • Maximal inspiratory pressure (MIP) \< 70%.

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Sham comparator
    Sham Myofascial + Respiratory rehabilitation

    Respiratory rehabilitation programme + sham Myofascial Release

    Other: Sham Myofascial + Respiratory rehabilitation

  • Experimental
    Experimental-Myofascial + Respiratory rehabilitation

    Respiratory rehabilitation programme + Myofascial Release

    Other: Experimental-Myofascial + Respiratory rehabilitation

Interventions

  • OtherExperimental-Myofascial + Respiratory rehabilitation

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

  • OtherSham Myofascial + Respiratory rehabilitation

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

06

What researchers measure

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.

    Time frame: 3 weeks

Secondary outcomes

  1. 6 Minutes Walking Test

    Maximum distance reached

    Time frame: 3 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 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. Erratum In: Arch Bronconeumol. 2017 Jul;53(7):411-412. doi: 10.1016/j.arbres.2017.06.001. English, Spanish. PubMed 28274597 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Mar 2027, 12 months later.

Of 1,095 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 12 months is below that.

Counting every sponsor, half of 1,182 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2020
First posted
Feb 7, 2020
StartEst.
Mar 2026
Primary completionEst.
Mar 2027
CompletionEst.
Jun 2027
Last update
Feb 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04260243
Lead sponsor
Cardenal Herrera University
Responsible party
ARGUISUELAS MARTINEZ MARÍA DOLORES (Head of Physiotherapy, Cardenal Herrera University) — Principal investigator
First posted
Feb 7, 2020
Start date
Mar 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Feb 12, 2025

Study contacts

MARÍA DOLORES ARGUISUELAS, PhD
Contact
doloresarguisuelas@uchceu.es
961369000 ext. 64352
JUAN FRANCISCO L PÁRRAGA, PhD
Contact
juanfran@uchceu.es
618055092
JUAN FRANCISCO L PÁRRAGA
study chair · Cardenal Herrera University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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