NCT06449573

Brief Summary

The aim of the study compare the cardiopulmonary parameters of individuals with asthma with healthy subjects.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

March 1, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

March 3, 2024

Last Update Submit

August 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity

    Exercise capacity will be assessed by Cardiopulmonary Exercise Test. The test will be performed on a bicycle ergometer. The test will be terminated when the target heart rate is reached or when the patient indicates that they are unable to continue the test. maximal oxygen consumption and the workload achieved will be recorded.

    20 minutes

Secondary Outcomes (5)

  • Respiratory muscle strength

    8 minutes

  • Peripheral muscle strength

    5 minutes

  • Grip strength

    3 minutes

  • Kinesiophobia

    3 minutes

  • Quality of Life (symptoms, mood, activity limitation, environmental exposure)

    10 minutes

Study Arms (2)

Asthma

Inclusion Criteria: * Patients receiving step 5 asthma treatment * 18-65 years * Asthma under control (asthma control test ≥20) * No more than 2 exacerbations in the last 1 year Exclusion Criteria: * Non-consenting * Patients with asthma exacerbation requiring systemic steroid use for at least 3 days in the last 1 month * Being an active smoker

Other: Exercise capacity

Healthy Individuals

Inclusion Criteria: * No respiratory, cardiovascular and metabolic diseases * Regular non-smoker Exclusion Criteria: * Non-consenting * Pregnant women

Other: Exercise capacity

Interventions

cardiopulmonary exercise test used assessment of exercise capacity

AsthmaHealthy Individuals

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include asthma patients followed up by Hacettepe University Faculty of Medicine, Department of Chest Diseases, Immunology and Allergy Branch and healthy individuals.

You may qualify if:

  • No respiratory, cardiovascular and metabolic diseases
  • Regular non-smoker

You may not qualify if:

  • Non-consenting
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Naciye Vardar Yagli

    Hacettepe University

    STUDY DIRECTOR
  • Melda Saglam

    Hacettepe University

    STUDY CHAIR
  • Ebru Damadoglu

    Hacettepe University

    STUDY CHAIR
  • Merve Firat

    Kirsehir Ahi Evran Universitesi

    STUDY CHAIR
  • Aydan Aslı Aksel Uylar

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Melek Cihanbeylerden

    Hacettepe University

    STUDY CHAIR

Central Study Contacts

Aydan Aslı Aksel Uylar

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

March 3, 2024

First Posted

June 10, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations