Comparison of Clinical Parameters in Chronic Obstructive... | NCT06677671

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

NCT06677671

Sponsor

Hacettepe University

Status

Active, not recruiting

Last Update Posted

Nov 7, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Actual

Primary Completion Date

Jul 18, 2026Estimated

Completion Date

Jul 18, 2026Estimated

First Submitted Date

Nov 3, 2024

First Submission Date that Met QC Criteria

Nov 5, 2024

First Posted Date

Nov 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2024

Last Update Posted Date

Nov 7, 2024Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
Healthy		Healthy Individuals
COPD		Chronic Obstructive Pulmonary Disease Patients

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease