- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06510686
Effects of Core Stabilization and Inspiratory Muscle Training in Patients With COPD (COPD)
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Sağlık Bilimleri Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: İnspiratory muscle training
Inspiratory muscle training during 8 weeks
|
exercises to strengthen inspiratory muscles
Other Names:
|
|
Other: Core Stabilization
Inspiratory muscle training and core training during 8 weeks
|
exercises to strengthen inspiratory muscles
Other Names:
exercises to strengthen inspiratory and core muscles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inspiratory Muscle Strength
Time Frame: 8 weeks
|
Maximal Inspiratory Pressure (MIP) (cmH2O),
|
8 weeks
|
|
Inspiratory Muscle Activation
Time Frame: 8 weeks
|
surface EMG (TLC from FRC (TLC maneuver)(cmH2O)
|
8 weeks
|
|
Respiratory function tests FEV1
Time Frame: 8 weeks
|
Spirometry, FEV1 (lt)
|
8 weeks
|
|
Respiratory function tests FVC
Time Frame: 8 weeks
|
Spirometry, FVC (lt)
|
8 weeks
|
|
Respiratory function tests PEF
Time Frame: 8 weeks
|
Spirometry, PEF (lt/sn)
|
8 weeks
|
|
Respiratory function tests FEV1/FVC
Time Frame: 8 weeks
|
Spirometry, FEV1/FVC %
|
8 weeks
|
|
Respiratory function MVV
Time Frame: 8 weeks
|
Spirometry, MVV(L/min)
|
8 weeks
|
|
Functional capacity
Time Frame: 8 weeks
|
Six Minute Walking Test (6MVT) (m)
|
8 weeks
|
|
Symptoms
Time Frame: 8 weeks
|
MMRC Dyspnea Scale (Scores range from 0 to 4)
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity,
Time Frame: 8 week
|
IPAQ (MET/minute)
|
8 week
|
|
Quality of life Tests
Time Frame: 8 week
|
SGRQ (Scores range from 0 to 100)
|
8 week
|
|
Core Strength
Time Frame: 8 week
|
1 minute sit to stand ( how many times sit and stand during 1 minute)
|
8 week
|
|
Core Strength flexion
Time Frame: 8 week
|
Mcgill Endurance Tests For Trunk Flexion (sec)
|
8 week
|
|
Core Strength extension
Time Frame: 8 week
|
Mcgill Endurance Tests For Trunk Extension (sec)
|
8 week
|
|
Core Strength side bridge
Time Frame: 8 week
|
Mcgill Endurance Tests For Side Bridge (sec)
|
8 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-183
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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