Comparison of Upper and Lower Limb Maximal Exercise Capacities and Muscle Oxygenation in Patients With ILD

NCT06141603 | Unknown

• 1 other identifier: Gazi University 28
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Interstitial lung diseases (ILD) are a complex group of diseases that cause significant morbidity and mortality, develop diffuse lung parenchyma and alveolar inflammation, as well as interstitial fibrosis, which refers to more than 200 diseases. Due to restrictive type ventilation disorder and impaired pulmonary gas exchange, pulmonary function has deteriorated in these patients and progressive shortness of breath, fatigue, cough and exercise intolerance are usually observed, which also affects the quality of life.

Conditions

Interstitial Lung Disease

Keywords

interstitial lung disease; muscle oxygenation; cardiopulmonary exercise testing

Outcome Measures

Primary Outcomes (1)

• Peripheral Muscle Oxygenation

  Peripheral muscle oxygen will be measured by near-infrared spectrometry. The device probes will be placed on the upper and lower extremities for both tests. The device allows to display of the percentage of oxygen, the concentration of oxyhemoglobin, and deoxyhemoglobin, the difference between oxyhemoglobin and deoxyhemoglobin, and the total hemoglobin. These parameters will be evaluated in our study.

  through study completion, an average of 1 year

Secondary Outcomes (12)

• Maximal Exercise Capacity

  through study completion, an average of 1 year

• Energy Consumption During Tests

  through study completion, an average of 1 year

• Physical Activity Level (Total energy expenditure)

  through study completion, an average of 1 year

• Physical activity (Active energy expenditure (joule / day))

  through study completion, an average of 1 year

• Physical activity (Physical activity time (min / day))

  through study completion, an average of 1 year

Study Arms (2)

Lower Extremity Group

The first test is the cardiopulmonary exercise test (CPET), which evaluates the maximal exercise capacity of the lower extremities and will be performed on a treadmill. During the test, the muscle oxygen of the individuals will be measured with a near-infrared spectrometer, and their energy consumption will be measured with a multisensory physical activity monitor.

Upper Extremity Group

In the second test, the maximal exercise capacity for the upper limb will again be evaluated by CPET and performed on the arm ergometer. The second test will be conducted 48 hours after the lower extremity exercise test. During the test in the second group, as in the first test, muscle oxygen will be measured with a near-infrared spectrometer, and energy expenditure with a multisensory physical activity monitor.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 patients diagnosed with interstitial lung disease will be recruited.

You may qualify if:

• patients between the ages of 18-75 with interstitial lung disease

You may not qualify if:

• acute infection during the study
• have an orthopedic or neurological disease that will affect their exercise capacity
• acute exacerbation or any infection
• have contraindications to the exercise test
• an acute respiratory infection
• had Coronavirus-19 (COVID-19) disease in the last 3 months
• have undergone different treatments other than standard medical treatment

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Beyza Nur ÖYMEZ, Pt.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Nilgün YILMAZ DEMİRCİ, Prof. Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

03122162647; meralbosnak@gazi.edu.tr

Beyza Nur ÖYMEZ, Pt.

CONTACT

beyzanuroymez@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: November 25, 2023
• Primary Completion: December 28, 2024
• Study Completion: December 30, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)