Evaluation of Cardiopulmonary Parameters in Individuals With Asthma

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

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Exercise capacity

Detailed Description

It is thought that aerobic capacity of asthmatic individuals decreases due to chronic respiratory disease, especially oxygen consumption. Detailed investigation will be provided with this research.

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Aydan Aslı Aksel Uylar; Phone Number: 3051576 +90312; Email: aydanaaksel@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Hacettepe University
    • Contact: Aydan Aslı Aksel Uylar; Phone Number: 3051576 +90312; Email: aydanaaksel@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Non-consenting
• Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; cardiopulmonary exercise test used assessment of exercise capacity
Healthy Individuals; Inclusion Criteria: No respiratory, cardiovascular and metabolic diseases; Regular non-smoker Exclusion Criteria: Non-consenting; Pregnant women	Other: Exercise capacity; cardiopulmonary exercise test used assessment of exercise capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle strength	Inspiratory and expiratory muscle strength will be measured with a mouth pressure measuring device. Measurements will be made in a sitting position with the hip and knee at 90 degrees and the trunk upright.	8 minutes
Peripheral muscle strength	It will be evaluated with a portable manual muscle strength measuring device. Muscle strength of knee extensors will be measured. The measurement will be performed with the patient sitting with his/her back unsupported and his/her hands crossed on his/her chest.	5 minutes
Grip strength	It will be evaluated with a portable hand dynamometer. Measurements will be made in a sitting position with the hip and knee at 90 degrees and the trunk upright. The measurement will be performed with the arm adjacent to the side of the trunk and the forearm parallel to the ground.	3 minutes
Kinesiophobia	Tampa Kinesiophobia Scale will be used. A total of 17 questions will be answered in 4-point Likert form. In total, the patient scores between 17-68. A high score indicates high kinesiophobia.	3 minutes
Quality of Life (symptoms, mood, activity limitation, environmental exposure)	Asthma Quality of Life Scale will be used for the evaluation. This scale consists of 4 sub-headings including symptoms, mood, activity limitation, environmental exposure and 32 questions. Each item is scored between 1-7. The total score of the scale is calculated by averaging the scores given to the items. The higher the score, the better the quality of life.	10 minutes

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Chair: Melda Saglam, Hacettepe University; Study Chair: Ebru Damadoğlu, Hacettepe University; Principal Investigator: Aydan Aslı Aksel Uylar, Hacettepe University; Study Director: Naciye Vardar Yagli, Hacettepe University; Study Chair: Merve Firat, Kirsehir Ahi Evran Universitesi; Study Chair: Melek Cihanbeylerden, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 3, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: GO 23/533

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No