Clinical trial NCT06677671: Comparison of Clinical Parameters in Chronic Obstructive Pulmonary Disease Patients and Healthy Individuals
Official title: Comparison of Exercise Capacity, Muscle Parameters and Quality of Life Parameters in Chronic Obstructive Pulmonary Disease Patients and Healthy Individuals
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: copd
exercise capacity
muscle parameters
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients and volunteer healthy individuals admitted to Ankara Etlik City Hospital

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiopulmonary exercise test
timeFrame: September 2024, July 2026
Secondary outcomes:
measure: Respiratory function
timeFrame: September 2024, July 2026
measure: Respiratory muscle strength
timeFrame: September 2024, July 2026
measure: Muscle activity and muscle thickness
timeFrame: September 2024, July 2026
measure: COPD Assessment Questionnaire
timeFrame: September 2024, July 2026
measure: Timed up and go test
timeFrame: September 2024, July 2026
measure: Functional reach test
timeFrame: September 2024, July 2026
measure: St George Health Questionnaire
timeFrame: September 2024, July 2026
measure: Hospital Anxiety and Depression Scale
timeFrame: September 2024, July 2026
measure: Six Minute Walk Test (6MWT)
timeFrame: September 2024- July 2026
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
References: