- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01223807
Effects of a Diaphragmatic Breathing Training Program in Chronic Obstructive Pulmonary Disease (COPD) Patients
Effects of a Short-term Diaphragmatic Breathing Training Program in COPD Patients: a Randomized Controlled Trial
Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients with chronic obstructive pulmonary disease (COPD). Several studies have described an impairment in diaphragmatic mobility of COPD patients compared to age matched control subjects and it has been associated with increase in dyspnea, exercise intolerance and mortality. COPD patients also experiment a higher activity of the accessory breathing muscles, which greatly increases the work of breathing and dyspnea sensation.
Breathing strategies have been considered an important component of pulmonary rehabilitation and refer to a range of techniques, including/which includes the diaphragmatic breathing (DB). The principal aim of DB is to improve the participation of the abdominal motion while reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality in the rehabilitation of COPD patients remains controversial. Despite the conflicting results, improvement of the abdominal motion and a reduction of thoracic excursion, during voluntarily DB, has been described as a common finding of several studies. The investigators hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this modification would relieve respiratory symptoms and improve exercise tolerance and the HRQoL. Therefore, in this randomized controlled trial the investigators aimed to test the effects of a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic mobility, dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: (1) age between 50 and 80 years; (2) a post-bronchodilator forced expiratory volume in one second (FEV1) < 80% of the predicted value and a FEV1/ forced vital capacity (CVF) ratio < 0,7; (3) stable respiratory/clinical condition without changes in medication and symptoms (dyspnea, volume or color of sputum) for at least 4 weeks before admission to the study; and (4) receiving regular treatment with inhaled bronchodilators and steroids.
Exclusion Criteria: (1) presence of other pulmonary, cardiovascular or musculoskeletal diseases; (2) previously participation in any exercise-training program in the last 2 years before participating in this study; and (3) current smokers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control Group
The control group will receive only usual care.
|
|
|
EXPERIMENTAL: Diaphragmatic breathing training
The training group will be submitted to a diaphragmatic breathing training program of 4 weeks.
|
The training group will participate in a diaphragmatic breathing program which will consist of three 45-min sessions each week (12 sessions totally).
The program training will be individualized and supervised by the same physiotherapist.
In each session, the patients will be initially instructed to perform 3 series of 10 maximally inspirations, predominantly with abdominal motion, while reducing upper rib cage motion in a supine position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
thoracoabdominal motion
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
diaphragmatic mobility
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- uspferd
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD
-
University Medical Center GroningenCompleted
-
Ryme Medical, Inc.Not yet recruitingCOPD | Lung Disease, Chronic Obstructive | COPD Patients | COPD Acute Exacerbation | COPD (Chronic Obstructive Pulmonary Disease) | Lung Disease Airways | COPD Exacerbations
-
Insel Gruppe AG, University Hospital BernUniversity Hospital, Geneva; Cantonal Hospital St. Gallen, SwitzerlandNot yet recruiting
-
Istituto Nazionale di Ricovero e Cura per AnzianiRecruiting
-
Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre...Recruiting
-
Sir Run Run Shaw HospitalRecruiting
-
The First Affiliated Hospital of Guangzhou Medical...Recruiting
-
Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)Recruiting
-
Polytechnic Institute of PortoNippon Gases PortugalRecruiting
-
China-Japan Friendship HospitalNot yet recruiting
Clinical Trials on Diaphragmatic breathing training
-
Riphah International UniversityCompletedCOVID-19 PandemicPakistan
-
Foundation University IslamabadRecruiting
-
Middle East UniversityNot yet recruitingPostmenopausal | Breathing Exercises | Depressive Symptom
-
Middle East UniversityNot yet recruitingRespiration Disorders | Fibromyalgia (FM)
-
Medipol UniversityRecruitingCardiorespiratory Fitness | Respiratory MusclesTurkey
-
Foundation University IslamabadRecruiting
-
Democritus University of ThraceUniversity of Crete (School of Medicine); University Hospital of Heraklion...CompletedChronic Non-specific Neck Pain | Chronic Non-specific Low-Back PainGreece
-
Dokuz Eylul UniversityCompleted
-
National Cheng Kung UniversityCompletedChronic Neck PainTaiwan
-
Palo Alto Veterans Institute for ResearchVA Palo Alto Health Care System; Brain & Behavior Research FoundationCompletedAnxiety DisordersUnited States