NCT04983472

Brief Summary

Chronic and progressive dyspnea is the most characteristic symptom of chronic obstructive pulmonary disease. There are studies in the literature showing that electromyography activations of respiratory muscles increase in individuals with chronic obstructive pulmonary disease and that the severity of the perceived shortness of breath is associated with muscle activation. However, no study has been found comparing respiratory muscle activations during pursed lip breathing and normal breathing in the dyspnea reduction positions and supine position used in the treatment and management of chronic obstructive pulmonary disease. The aim of this study is to evaluate the effects of different dyspnea reduction positions on respiratory muscle activations separately, to compare respiratory muscle activation during normal breathing, respiratory control and pursed lip breathing during these different positions, and to classify muscle activations according to the severity of chronic obstructive pulmonary disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

July 20, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

July 9, 2021

Last Update Submit

March 27, 2023

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseSurface ElectromyographyVentilationDyspnea

Outcome Measures

Primary Outcomes (1)

  • Surface Electromyography

    Activation of respiratory muscles will be performed with a surface Electromyography (EMG) device. The measurement will be performed by placing Electromyography (EMG) electrodes on the motor points of the respiratory muscles. Increased respiratory muscle activations indicate that respiratory muscles are used more; The decrease in respiratory muscle activations indicates that the respiratory muscles are used less.

    45 minutes

Secondary Outcomes (4)

  • Measurement of Maximal Inspiratory Pressure

    5 minutes

  • Pulmonary Function Test

    5 minutes

  • Chronic Obstructive Pulmonary Disease Assessment Test

    5 minutes

  • Modified Medical Research Council Dyspnea Scale

    2 minutes

Study Arms (1)

Observational Group

Individuals diagnosed with Chronic Obstructive Pulmonary Disease by the Department of Pulmonology of the Faculty of Medicine of Bolu Abant Izzet Baysal University will be referred to the Department of Physiotherapy and rehabilitation of the Faculty of Health Sciences of Bolu Abant Izzet Baysal University

Other: Observational

Interventions

Respiratory muscle electromyographic activations of individuals will be taken during supine, normal sitting and dyspnea reduction positions. Individuals with chronic obstructive pulmonary disease will be asked to perform normal breathing, pursed lip breathing, and breathing control during these positions. Respiratory muscle activation measurement of individuals will be taken during different breathing patterns in each position. Respiratory functions will be evaluated with pulmonary function test, respiratory muscle strength, intraoral pressure measurement device, respiratory muscle activation with surface electromyographic device, health status disorder with Chronic Obstructive Pulmonary Disease Assessment Scale, dyspnea with Modified Medical Research Council Dyspnea Scale and Modified Borg Scale. Participants' names, anthropometric measurements, demographic data, contact information and medical history will be collected and recorded with the patient anamnesis form.

Observational Group

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease characterized by persistent respiratory symptoms and airway limitation due to airway and/or alveolar abnormality resulting from exposure to harmful gases or particles and many factors that cause abnormal lung development.

You may qualify if:

  • Individuals diagnosed with chronic obstructive pulmonary disease
  • Be between the ages of 40-65
  • No medication changes due to acute exacerbation for at least three weeks
  • Be stable
  • Volunteering to participate in research
  • To cooperate
  • Patients with written consent form
  • Healthy individuals in a similar age range without a diagnosed disease and symptoms will be included

You may not qualify if:

  • Those with a history of chronic obstructive pulmonary disease exacerbations
  • Individuals with orthopedic disease
  • Individuals with neurological disease
  • Individuals with other co-existing lung and systemic diseases other than chronic obstructive pulmonary disease
  • Those who have had major surgery in the past few months
  • Individuals with a history of recurrent significant clinical infections
  • Have cognitive problems
  • Having had unstable angina,
  • Previous Myocardial Infarction
  • Individuals with severe congestive heart failure refractory to medical therapy, individuals with uncontrolled hypertension
  • Individuals with cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University Department of Physiotherapy and Rehabilitation

Bolu, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory AspirationDyspnea

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

Eylem TÜTÜN YÜMİN, Assoc Prof.

CONTACT

Ceyhun TOPCUOĞLU, Res. Assist.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 30, 2021

Study Start

July 20, 2021

Primary Completion

January 20, 2023

Study Completion

May 20, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations