NCT06677671

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2024Jul 2026

Study Start

First participant enrolled

September 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2026

Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

November 3, 2024

Last Update Submit

November 5, 2024

Conditions

Keywords

copdexercise capacitymuscle parameters

Outcome Measures

Primary Outcomes (1)

  • 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 (9)

  • Respiratory function

    September 2024, July 2026

  • Respiratory muscle strength

    September 2024, July 2026

  • Muscle activity and muscle thickness

    September 2024, July 2026

  • COPD Assessment Questionnaire

    September 2024, July 2026

  • Timed up and go test

    September 2024, July 2026

  • +4 more secondary outcomes

Study Arms (2)

Healthy

Healthy Individuals

COPD

Chronic Obstructive Pulmonary Disease Patients

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06170, 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
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, M.Sc

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 7, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

July 18, 2026

Study Completion (Estimated)

July 18, 2026

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations