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Clinical Trials/NCT06510686
NCT06510686CompletedNot Applicable

Comparison of the Effects of Core Stabilization and Inspiratory Muscle Training on Diaphragm Activation, Inspiratory Muscle Strength, Functional Capacity, Respiratory Functions, Physical Activity and Quality of Life in Patients With COPD

Mustafa Ertuğrul Yaşa1 site in 1 country36 target enrollmentStarted: October 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
Symptoms

Study Overview

Brief Summary

In Chronic Obstructive Pulmonary Disease (COPD), a mismatch develops between the respiratory system's demand and the functional capacity of respiratory muscles due to the combination of local and systemic factors increasing the respiratory workload. This results in impaired coordination of muscle groups, leading to muscle dysfunction. Respiratory muscle dysfunction is a significant determinant of life expectancy in COPD. Additionally, respiratory muscles unable to cope with increased workloads lead to impaired respiratory functions and reduced exercise capacity.

It is widely accepted that appropriate training of respiratory muscles can increase their strength, endurance, and their close relationship with lung volume capacities. Besides their role in respiration, respiratory muscles also contribute to postural function and core stabilization. Studies on respiratory muscle training in COPD have primarily focused on inspiratory muscle strength training, neglecting the core stabilization function of respiratory muscles. However, optimal gains in a muscle can only be achieved with training tailored to its functional characteristics. Therefore, a comprehensive training program should be developed considering the multifunctional nature of respiratory muscles. Studies published in healthy individuals and different patient populations demonstrate that core training can improve lung functions. The aim of this study is to compare the effects of inspiratory muscle training and core stabilization training on diaphragm activation, inspiratory muscle strength, functional capacity, respiratory functions, physical activity, and quality of life in individuals with COPD.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Being over 18 years old
  • Having a diagnosis of COPD according to the GOLD criteria and being at stage 3 or lower
  • Not being in an acute exacerbation period and having at least one month since the last exacerbation
  • Being able to walk independently
  • Having sufficient mental capacity to understand the tasks in the study (Mini-Mental Test >24)
  • Being willing to participate in the study

Exclusion Criteria

  • Being a stage 4 COPD patient according to the GOLD criteria
  • Having a diagnosis of lung cancer, pulmonary hypertension, and heart failure
  • Being in a COPD exacerbation period
  • Scoring below 24 on the Mini-Mental Test
  • Having any other disease that affects respiratory functions
  • Having undergone pulmonary surgery

Outcomes

Primary Outcomes

Symptoms

Time Frame: 8 weeks

MMRC Dyspnea Scale (Scores range from 0 to 4)

Inspiratory Muscle Strength

Time Frame: 8 weeks

Maximal Inspiratory Pressure (MIP) (cmH2O),

Respiratory function tests PEF

Time Frame: 8 weeks

Spirometry, PEF (lt/sn)

Inspiratory Muscle Activation

Time Frame: 8 weeks

surface EMG (TLC from FRC (TLC maneuver)(cmH2O)

Respiratory function tests FEV1

Time Frame: 8 weeks

Spirometry, FEV1 (lt)

Respiratory function tests FVC

Time Frame: 8 weeks

Spirometry, FVC (lt)

Respiratory function tests FEV1/FVC

Time Frame: 8 weeks

Spirometry, FEV1/FVC %

Respiratory function MVV

Time Frame: 8 weeks

Spirometry, MVV(L/min)

Functional capacity

Time Frame: 8 weeks

Six Minute Walking Test (6MVT) (m)

Secondary Outcomes

  • Physical activity,(8 week)
  • Quality of life Tests(8 week)
  • Core Strength extension(8 week)
  • Core Strength(8 week)
  • Core Strength flexion(8 week)
  • Core Strength side bridge(8 week)

Investigators

Sponsor
Mustafa Ertuğrul Yaşa
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mustafa Ertuğrul Yaşa

assistant professor

Gulhane School of Medicine

Study Sites (1)

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