NCT06510686

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

July 3, 2024

Last Update Submit

August 29, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • Inspiratory Muscle Strength

    Maximal Inspiratory Pressure (MIP) (cmH2O),

    8 weeks

  • Inspiratory Muscle Activation

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

    8 weeks

  • Respiratory function tests FEV1

    Spirometry, FEV1 (lt)

    8 weeks

  • Respiratory function tests FVC

    Spirometry, FVC (lt)

    8 weeks

  • Respiratory function tests PEF

    Spirometry, PEF (lt/sn)

    8 weeks

  • Respiratory function tests FEV1/FVC

    Spirometry, FEV1/FVC %

    8 weeks

  • Respiratory function MVV

    Spirometry, MVV(L/min)

    8 weeks

  • Functional capacity

    Six Minute Walking Test (6MVT) (m)

    8 weeks

  • Symptoms

    MMRC Dyspnea Scale (Scores range from 0 to 4)

    8 weeks

Secondary Outcomes (6)

  • Physical activity,

    8 week

  • Quality of life Tests

    8 week

  • Core Strength

    8 week

  • Core Strength flexion

    8 week

  • Core Strength extension

    8 week

  • +1 more secondary outcomes

Study Arms (2)

İnspiratory muscle training

OTHER

Inspiratory muscle training during 8 weeks

Other: İnspiratory muscle training

Core Stabilization

OTHER

Inspiratory muscle training and core training during 8 weeks

Other: İnspiratory muscle trainingOther: Core training

Interventions

exercises to strengthen inspiratory muscles

Also known as: Normal breath exercises and İnspiratory muscle training
Core Stabilizationİnspiratory muscle training

exercises to strengthen inspiratory and core muscles

Also known as: Normal breath exercises and İnspiratory muscle training and Core Stabilization
Core Stabilization

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 19, 2024

Study Start

October 1, 2024

Primary Completion

May 3, 2025

Study Completion

June 5, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Locations