CopdMFR-COPDNCT04260243
Myofascial Release in Patients with Chronic Obstructive Pulmonary Disease
A study testing Experimental-Myofascial + Respiratory rehabilitation in people with Copd, run by Cardenal Herrera University.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Copd
- What is being tested?
- Experimental-Myofascial + Respiratory rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD;
- Forced expiratory volume in the first second (FEV1) < 80%;
- FEV1/Forced vital capacity (FVC) < 70%;
- Maximal inspiratory pressure (MIP) < 70%.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Myofascial Release in Patients with Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
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
- Conditions
- Copd
- Being tested
- Experimental-Myofascial + Respiratory rehabilitation, Sham Myofascial + Respiratory rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental-Myofascial + Respiratory rehabilitationOther
6 sessions of: Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)
Sham Myofascial + Respiratory rehabilitationOther
6 sessions of: Sham Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)
| Study group | Role | What they receive |
|---|---|---|
| Sham Myofascial + Respiratory rehabilitation | Sham comparator | Respiratory rehabilitation programme + sham Myofascial Release Receives: Other: Sham Myofascial + Respiratory rehabilitation |
| Experimental-Myofascial + Respiratory rehabilitation | Experimental | Respiratory rehabilitation programme + Myofascial Release Receives: Other: Experimental-Myofascial + Respiratory rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured with the Chronic Obstructive Pulmonary Disease Assessment Test: Score
Score (0-40) higher scores mean a worse outcome.
Measured: 3 weeks
Secondary outcomes (1)
6 Minutes Walking Test
Maximum distance reached
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARGUISUELAS MARTINEZ MARÍA DOLORES, Cardenal Herrera University
- Investigators
- JUAN FRANCISCO L PÁRRAGA, Study chair, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260243
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-23
- Acronym
- MFR-COPD
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2020
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 26386894Vogelmeier 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.
PubMed 28274597
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Release in Patients with Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04260243
- Acronym / sponsor ID
- MFR-COPD / UNIVERSITY CARDENAL HERRERA-23
- Conditions
- Copd
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to assess the effects of a myofascial release protocol in patients with chronic obstructive pulmonary disease (COPD).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Myofascial + Respiratory rehabilitation | Sham comparator | Other: Sham Myofascial + Respiratory rehabilitationRespiratory rehabilitation programme + sham Myofascial Release |
| Experimental-Myofascial + Respiratory rehabilitation | Experimental | Other: Experimental-Myofascial + Respiratory rehabilitationRespiratory rehabilitation programme + Myofascial Release |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD;
- Forced expiratory volume in the first second (FEV1) < 80%;
- FEV1/Forced vital capacity (FVC) < 70%;
- Maximal inspiratory pressure (MIP) < 70%.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental-Myofascial + Respiratory rehabilitation6 sessions of: Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each) | Other | Experimental-Myofascial + Respiratory rehabilitation |
| Sham Myofascial + Respiratory rehabilitation6 sessions of: Sham Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each) | Other | Sham Myofascial + Respiratory rehabilitation |
Primary outcome
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.
1 secondary outcome
6 Minutes Walking Test
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 26386894Rocha 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.
- Background: PubMed 28274597Vogelmeier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JUAN FRANCISCO L PÁRRAGA study chair
Cardenal Herrera University
Questions about this trial
What is this clinical trial studying?
A study testing Experimental-Myofascial + Respiratory rehabilitation in people with Copd, run by Cardenal Herrera University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARÍA DOLORES ARGUISUELAS, PhD (961369000 ext. 64352, doloresarguisuelas@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measured with the Chronic Obstructive Pulmonary Disease Assessment Test: Score (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04260243, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.