Comparison of Clinical Parameters in Chronic Obstructive Pulmonary Disease Patients and Healthy Individuals

Comparison of Exercise Capacity, Muscle Parameters and Quality of Life Parameters in Chronic Obstructive Pulmonary Disease Patients and Healthy Individuals

The investigators think that the functions of core stabilization muscles are different in chronic obstructive pulmonary disease (COPD) patients than in healthy individuals. This muscle group plays an important role not only in stabilization but also in respiratory parameters. No study has been found investigating the functions of these muscles in this patient group. The investigators aimed to compare respiratory parameters, muscle parameters, exercise capacity, balance, quality of life, anxiety and depression levels in individuals with COPD and healthy individuals.

Study Overview

• Status: Active, not recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Detailed Description

Individuals diagnosed with COPD between the ages of 40-80 who applied to Ankara Etlik City Hospital Chest Diseases Polyclinic will be included in the study. Healthy individuals will be between the ages of 40-80 who volunteered to participate in the study. Data collection tools will be made by the same researchers.

For calculating the sample size required for the study, a power analysis will be conducted using pilot data after evaluating 10 individuals with COPD and 10 healthy adults.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06170
    • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

COPD patients and volunteer healthy individuals admitted to Ankara Etlik City Hospital

Description

Inclusion Criteria:

Inclusion Criteria for Individuals with COPD:

• Being diagnosed with COPD
• Being between the ages of 40-80
• Being clinically stable (not having had an exacerbation in the last month)
• Being able to cooperate with the tests
• Not participating in any exercise training studies
• Being willing to participate in the study

Inclusion Criteria for Healthy Individuals:

• Being between the ages of 40-80
• Not having a known acute or chronic health problem that would prevent the performance of the tests or affect the performance of the tests
• Not participating in any exercise training program
• Being willing to participate in the study

Exclusion Criteria:

Exclusion Criteria for Individuals with COPD:

• Having other lung or lung involvement diseases other than COPD
• Having uncontrolled hypertension, arrhythmia and a history of myocardial infarction in the last month, unstable angina, advanced heart failure and other cardiac instability conditions
• Being hemodynamically unstable
• Being on noninvasive mechanical ventilation (NIMV) and long-term oxygen therapy (LTOT)
• Having a history of neuromuscular disease, scoliosis, chest wall surgery
• Having pregnancy and malignancy
• Having orthopedic or surgical conditions that would prevent participation in tests
• Not willing to participate in the study

Exclusion Criteria for Healthy Individuals:

• Having a known acute or chronic health problem that would prevent the performance of the tests or affect the performance of the tests
• Being pregnant
• Not willing to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy; Healthy Individuals
COPD; Chronic Obstructive Pulmonary Disease Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary exercise test	Cardiopulmonary exercise test will be performed to evaluate the exercise capacity of the individuals who will participate in the study. During the test, individuals' respiratory and cardiac parameters will be recorded.	September 2024, July 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory function	Respiratory functions will be assessed using spirometry (Cosmed Microquark-PC Based Spirometer, Rome, Italy) according to the criteria of the European Respiratory Society (ERS) and the American Thoracic Society (ATS).	September 2024, July 2026
Respiratory muscle strength	Respiratory muscle strength will be assessed with a portable, electronic oral pressure measuring device (Cosmed Pony Fx, Milan, Italy). Respiratory muscle strength will be determined by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Percentage of expected reference values according to gender and age will be used for the MIP value. The clinical significance for this patient group is 17.2 cmH2O for the measured MIP value.	September 2024, July 2026
Muscle activity and muscle thickness	In our study, muscle activity and thickness of transversus abdominis (TrA), rectus abdominis (RA), lumbar multifidus (LM) and quadriceps muscles will be evaluated to evaluate muscle function. Muscle activity will be evaluated using surface electromyography (EMG) (Neuro-MEP, Ivanovo, Russia) and muscle thickness will be evaluated using ultrasound (LOGIQ P9, GE Healthcare, USA).	September 2024, July 2026
COPD Assessment Questionnaire	The COPD Assessment Test (CAT) will be used to assess health status impairment in individuals with COPD. The CAT is an eight-item test consisting of questions that evaluate the severity of symptoms such as dyspnea, cough, and sputum production and the impact of the disease on daily life. It is recommended that the minimal clinical significance is a change of 2 points.	September 2024, July 2026
Timed up and go test	The Timed Up and Go Test (TUG) will be used for the balance assessment of individuals participating in the study. TUG is a frequently used, easily applicable, valid and reliable, performance-based functional mobility and balance test that evaluates dynamic balance in the clinic. It has been shown that dynamic balance impairment in COPD is associated with inadequate oxygenation and peripheral muscle weakness. Individuals who complete the test in 12 seconds or more have a risk of falling	September 2024, July 2026
Functional reach test	Functional reach test will be used for the balance assessment of individuals participating in the study. Individuals who can reach 25 cm and more have a low risk of falling. Individuals who can reach between 15-25 cm have a 2 times higher risk of falling than normal. Individuals who can reach 15 cm and below have a 4 times higher risk of falling than normal. Individuals who cannot reach at all have an 8 times higher risk of falling than normal.	September 2024, July 2026
St George Health Questionnaire	St. George's Respiratory Questionnaire (SGRQ), a seventy-six-item health-related quality of life assessment questionnaire, will be used to assess the quality of life of the subjects.The result values are between 0 and 100 and the higher the value, the greater the degree to which the patient's quality of life is affected by the disease.	September 2024, July 2026
Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression (HAD) scale will be used to determine the anxiety and depression levels of individuals participating in the study. This scale is a self-report scale that includes anxiety and depression subscales and consists of 14 items, seven of which investigate depression and seven of which investigate anxiety levels.The cut-off point for the anxiety subscale of the HAD Turkish form was found to be 10 and the cut-off point for the depression subscale was found to be 7. Patients who score above these points can be considered as a risk group. Anxiety and depression score 07: normal, 8-11: borderline, >11: anxiety and depression.	September 2024, July 2026
Six Minute Walk Test (6MWT)	6MWT will be used to evaluate the exercise capacities of individuals who will participate in the study. The individuals' walking distance and cardiac parameters during the test will be recorded.	September 2024- July 2026

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): July 18, 2026
• Study Completion (Estimated): July 18, 2026

Study Registration Dates

• First Submitted: November 3, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: exercise capacity; copd; muscle parameters
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: AEŞH-BADEK-2024-553

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No