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Myofascial Release in Patients With Chronic Obstructive Pulmonary Disease (MFR-COPD)

Primary Purpose

Copd

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental-Myofascial + Respiratory rehabilitation
Sham Myofascial + Respiratory rehabilitation
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Copd

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Sham Myofascial + Respiratory rehabilitation

    Experimental-Myofascial + Respiratory rehabilitation

    Arm Description

    Respiratory rehabilitation programme + sham Myofascial Release

    Respiratory rehabilitation programme + Myofascial Release

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    6 Minutes Walking Test
    Maximum distance reached

    Full Information

    First Posted
    February 5, 2020
    Last Updated
    September 1, 2023
    Sponsor
    Cardenal Herrera University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04260243
    Brief Title
    Myofascial Release in Patients With Chronic Obstructive Pulmonary Disease
    Acronym
    MFR-COPD
    Official Title
    Effects of Myofascial Release in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cardenal Herrera University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Copd

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sham Myofascial + Respiratory rehabilitation
    Arm Type
    Sham Comparator
    Arm Description
    Respiratory rehabilitation programme + sham Myofascial Release
    Arm Title
    Experimental-Myofascial + Respiratory rehabilitation
    Arm Type
    Experimental
    Arm Description
    Respiratory rehabilitation programme + Myofascial Release
    Intervention Type
    Other
    Intervention Name(s)
    Experimental-Myofascial + Respiratory rehabilitation
    Intervention Description
    6 sessions of: Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)
    Intervention Type
    Other
    Intervention Name(s)
    Sham Myofascial + Respiratory rehabilitation
    Intervention Description
    6 sessions of: Sham Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)
    Primary Outcome Measure Information:
    Title
    Quality of life measured with the Chronic Obstructive Pulmonary Disease Assessment Test: Score
    Description
    Score (0-40) higher scores mean a worse outcome.
    Time Frame
    3 weeks
    Secondary Outcome Measure Information:
    Title
    6 Minutes Walking Test
    Description
    Maximum distance reached
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MARÍA DOLORES ARGUISUELAS, PhD
    Phone
    961369000
    Ext
    64352
    Email
    doloresarguisuelas@uchceu.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    JUAN FRANCISCO L PÁRRAGA, PhD
    Phone
    618055092
    Email
    juanfran@uchceu.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    JUAN FRANCISCO L PÁRRAGA
    Organizational Affiliation
    Cardenal Herrera University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26386894
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28274597
    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.
    Results Reference
    background

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    Myofascial Release in Patients With Chronic Obstructive Pulmonary Disease

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