Clinical trial NCT05916404: Effects of Upper Extremity Aerobic Exercise Training in Patients With Interstitial Lung Disease
Official title: Investigation of the Effects of Upper Extremity Aerobic Exercise Training on Oxygen Consumption, Muscle Oxygenation and Physical Activity in Patients With Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: Interstitial Lung Disease
Upper Extremity
Aerobic Exercise
Oxygen Consumption
Physical Activity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Severe dyspnea, cough, fatigue, restrictive type ventilation disorder, decreased pulmonary function, impaired gas exchange, decreased cardiovascular function and exercise intolerance are frequently encountered findings in patients with interstitial lung disease. It was demonstrated exercise training has beneficial effects in patients with interstitial lung disease. However, no study investigated the effects of upper extremity aerobic exercise training on outcomes in patients with interstitial lung disease.

Detailed description: Interstitial lung diseases (ILD) are a heterogeneous group of diseases that cause significant mortality and morbidity worldwide. As a result of the chronic inflammatory process in this disease, structural and mechanical pulmonary disorders develop, which are considered the main causes of deterioration in cardiopulmonary functions. Interstitial lung patients have a decrease in both static and dynamic lung volumes and carbon monoxide diffusing capacity (DLCO). As a result of this pathological mechanism, effort dyspnea and an increase in exercise intolerance occur. Therefore, individuals with ILD tend to avoid activities that increase shortness of breath, resulting in decreased physical activity levels and an increased sedentary lifestyle. Individuals whose functional exercise capacities are also limited due to this vicious circle become more dependent in their daily living activities. In addition, peripheral muscle dysfunction is another important factor that causes exercise intolerance in individuals with all chronic lung diseases, including ILD. One of the most important mechanisms triggering peripheral muscle dysfunction in ILD is hypoxia which develops with desaturation. Hypoxia, which causes an increase in oxidative stress, is one of the factors that can cause muscle dysfunction. It has been reported that upper extremity exercise capacity and functional performance are low in individuals with advanced ILD, and it has been stated that upper extremity exercise training may be beneficial in these patients.

However, the effects of upper extremity aerobic exercise training have not been investigated in the literature in patients with ILD. In this context, the primary aim of our study is to investigate the effects of upper extremity interval aerobic exercise training applied to patients with ILD on oxygen consumption, muscle oxygenation, and physical activity level. The secondary aim of the study is to determine the effects of this training on upper extremity functional exercise capacity, respiratory functions, pulmonary diffusion capacity, respiratory and peripheral muscle strength, inspiratory muscle endurance, dyspnea, fatigue, quality of life, sleep quality, anxiety, and depression. For this purpose, our study was planned as a randomized, controlled, three-blind (investigators, patient, and analyzer) prospective study. According to the block randomization result, at least 21 patients with a diagnosis of ILD will be included in the training and control groups.

The training group will be given upper extremity interval aerobic exercise training with arm ergometer for 30-45 minutes 3 days a week for 6 weeks, and the control group will not be given any training during the study. After the study, the treatment applied to the training group will also be applied to the control group in order to ensure that the patients in the control group are not ethically deprived of rehabilitation.

All assessments will be completed in two days, before and after six weeks of training.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with ILD according to ATS/ERS criteria,
* Aged between 18-75 years,
* No pulmonary infection during the last month,
* Patients who volunteer to participate in the study

Exclusion Criteria:

Patients with,

* Body mass index \>35 kg/m2,
* An acute pulmonary exacerbation within the last 4 weeks, have an acute upper or lower respiratory tract infection,
* Presence of obstructive pulmonary disease,
* Serious neurological, neuromuscular, orthopedic, or other diseases affecting physical functions,
* Participated in a planned exercise program within the last three months,
* Cognitive impairment that causes them to have difficulty understanding and following exercise test instructions,
* Contraindications for exercise testing and/or exercise training according to the American College of Sports Medicine
* Cancer, renal or hepatic diseases,
* Aortic stenosis, complex arrhythmia, with aortic aneurysm,
* Uncontrolled hypertension, diabetes mellitus, heart failure, arrhythmia and serious cardiovascular disease

Primary outcomes:
measure: Oxygen consumption
timeFrame: through study completion, an average of 2 year
measure: Muscle oxygenation
timeFrame: through study completion, an average of 2 year
measure: Physical activity level
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: through study completion, an average of 2 year
measure: Peripheral muscle strength
timeFrame: through study completion, an average of 2 year
measure: Upper extremity functional exercise capacity
timeFrame: through study completion, an average of 2 year
measure: Dyspnea perception
timeFrame: through study completion, an average of 2 year
measure: Fatigue
timeFrame: through study completion, an average of 2 year
measure: Life Quality
timeFrame: through study completion, an average of 2 year
measure: Sleep Quality
timeFrame: through study completion, an average of 2 year
measure: Anxiety and Depression
timeFrame: through study completion, an average of 2 year
measure: Modified Borg scale
timeFrame: through study completion, an average of 2 year
measure: Energy expenditure
timeFrame: through study completion, an average of 2 year
measure: Inspiratory muscle endurance
timeFrame: through study completion, an average of 2 year
measure: Forced expiratory volume exhaled in the first second (FEV1)
timeFrame: through study completion, an average of 2 year
measure: Forced vital capacity (FVC)
timeFrame: through study completion, an average of 2 year
measure: FEV1/FVC ratio
timeFrame: through study completion, an average of 2 year
measure: Peak expiratory flow (PEF)
timeFrame: through study completion, an average of 2 year
measure: Forced mid-expiratory flow rate (FEF25-75%)
timeFrame: through study completion, an average of 2 year
measure: Diffusion capacity for carbon monoxide (DLCO)
timeFrame: through study completion, an average of 2 year
measure: Carbon monoxide transfer coefficient (KCO=DLCO/Va)
timeFrame: through study completion, an average of 2 year
measure: Alveolar ventilation (Va)
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
state: Çankaya
Study officials:
affiliation: Gazi University
name: Nazire Nur YILDIZ, M.Sc.
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Riad BEJTA, Pt.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Nilgün YILMAZ DEMİRCİ, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: