Myofascial Release in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
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

Official Title
-----------------
Effects of Myofascial Release in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial

Conditions
-----------------
Copd

Intervention / Treatment
-----------------
* Other: Experimental-Myofascial + Respiratory rehabilitation
* Other: Sham Myofascial + Respiratory rehabilitation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Myofascial + Respiratory rehabilitation<br>Respiratory rehabilitation programme + sham Myofascial Release | Other: Sham Myofascial + Respiratory rehabilitation<br>* 6 sessions of: Sham Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)<br>|
| Experimental: Experimental-Myofascial + Respiratory rehabilitation<br>Respiratory rehabilitation programme + Myofascial Release | Other: Experimental-Myofascial + Respiratory rehabilitation<br>* 6 sessions of: Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minutes Walking Test | Maximum distance reached | 3 weeks |