NCT04974788

Brief Summary

It has been observed in the literature that respiratory muscle electromyography activations at certain threshold loads have been examined in individuals with chronic obstructive pulmonary disease. However, no study has been found in the literature examining the acute effects of respiratory muscle training given at low, medium and high threshold loads on respiratory muscle activations. With this planned study, it is aimed to examine the electromyography activations of respiratory muscles before and after respiratory muscle training and to contribute to the literature by comparing the acute effects of respiratory muscle training applied at low, medium and high intensity on respiratory muscle electromyography activations.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

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
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

July 9, 2021

Last Update Submit

October 27, 2022

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseSurface EMGVentilationRespiratory Muscle Training

Outcome Measures

Primary Outcomes (1)

  • Surface Electromyography (EMG)

    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 (5)

  • Pulmonary Function Test

    10 minutes

  • Measurement of Maximal Inspiratory Pressure

    5 minutes

  • Chronic Obstructive Pulmonary Disease Assessment Test (CAT):

    5 minutes

  • Modified Medical Research Council Dyspnea Scale:

    2 minutes

  • Modified Borg Scale (MBS):

    2 minutes

Study Arms (3)

Low Intensity Respiratory Muscle Training Group

ACTIVE COMPARATOR

Low intensity respiratory muscle training will be applied to those with chronic obstructive pulmonary disease. Respiratory muscle training will be performed at 30% (low intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength.

Other: Low Intensity Respiratory Muscle Training

Medium Intensity Respiratory Muscle Training Group

ACTIVE COMPARATOR

Medium intensity respiratory muscle training will be applied to those with chronic obstructive pulmonary disease. Respiratory muscle training will be performed at 60% (medium intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength.

Other: Medium Intensity Respiratory Muscle Training

High Intensity Respiratory Muscle Training Group

ACTIVE COMPARATOR

High intensity respiratory muscle training will be applied to those with chronic obstructive pulmonary disease. Respiratory muscle training will be performed at 80% (high intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength.

Other: High Intensity Respiratory Muscle Training

Interventions

Respiratory muscle training will be performed at 30% (low intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions.

Low Intensity Respiratory Muscle Training Group

Respiratory muscle training will be performed at 60% (medium intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions.

Medium Intensity Respiratory Muscle Training Group

Respiratory muscle training will be performed at 80% (high intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions.

High Intensity Respiratory Muscle Training Group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals diagnosed with chronic obstructive pulmonary disease
  • Be between the ages of 40-75
  • 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

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Central Study Contacts

Eylem TÜTÜN YÜMİN, Assoc. Prof.

CONTACT

Ceyhun TOPCUOĞLU, Res. Assist.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups with a conventional therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 23, 2021

Study Start

June 30, 2023

Primary Completion

July 30, 2023

Study Completion

August 30, 2023

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share