Izmir Katip Celebi University
Izmir, 35620, Turkey (Türkiye)
NCT Number: NCT05482633
The aim of this study is to investigate the effectiveness of inspiratory muscle training (IMT) in increasing respiratory muscle strength in patients with juvenile idiopathic arthritis.
Looking for future studies?
Notify Me13 year–18 year
All sexes
Interventional
Not applicable
Izmir, 35620, Turkey (Türkiye)
Primary pulmonary involvement is an important aspect that leads to morbidity and mortality in adult patients with rheumatoid arthritis [1,2] but is not as frequent in patients with juvenile idiopathic arthritis (JIA), (prevalence; 4-8%) [3]. However, a body of evidence indicates that respiratory functions are affected in more than 50% of all children with JIA, even in those without radiological involvement [1,2,4]. Previous studies comparing children with JIA to their healthy peers showed that forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak flow rate (PEF), and carbon monoxide diffusion capacity (DLCO) are decreased and the maximum inspiratory pressure (PImax) and maximum expiratory pressures (PEmax), which are used to assess respiratory muscle strength, are significantly lower [2,4]. In addition, it has been reported that disease-modifying drugs (DMARDs) and non-steroidal anti-inflammatory drugs (NSAIDs), which are frequently used in the treatment of patients with JIA may cause a decrement in respiratory functions [5]. It has been suggested that the decrease in the pulmonary functions in patients with JIA without radiological involvement of the lung parenchyma or thorax may be caused by the weakness of inspiratory and expiratory muscles [2]. Moreover, symptoms and signs such as chronic joint pain and stiffness, synovitis, and deformity seen in children with JIA may limit movement, leading to an inactive lifestyle. Evidence suggests that children with JIA have lower levels of physical activity than age-matched controls [6,7]. This inactive lifestyle accompanying the disease process; may cause decline in aerobic and anaerobic capacity, peripheral muscle strength and quality of life [8,9].
Inspiratory muscle training (IMT) is defined as a technique that aims to improve the function and strength of respiratory muscles through performing exercises with a specialized device [10,11]. There is evidence that the IMT method improves functional status and increases respiratory muscle strength, respiratory volumes, and aerobic exercise capacity in adult rheumatologic patients [12,13]. IMT seems to increase perfusion and muscle metabolism in both respiratory and extremity muscles, provide muscle fiber type conversion, create neural plasticity at respiratory synapses in the central nervous system, and modulate dyspnea in different populations [14]. Despite this, the effectiveness of IMT has not been investigated in patients with JIA.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment group will perform IMT every day for eight weeks. Initial load is going to be set as the 60% of maximal inspiratory pressure (PImax) and is going to be increased by %10 of the initial load every two weeks.
Time frame: Change from baseline PImax at 8th week
Maximal inspiratory pressure (PImax) is the highest subatmospheric pressure achieved when inspiring against a closed airway.
Time frame: Change from baseline PEmax at 8th week
Maximal expiratory pressure (PEmax) is the highest pressure achieved during forced expiration against a closed airway. PEmax is indicative of the strength of expiratory muscles.
Time frame: Change from baseline VO2max at 8th week
VO2max is going to be evaluated using Cardiopulmonary exercise test (CPET). CPET is a non-invasive procedure that evaluates an individual's capacity during dynamic exercise and provides diagnostic and prognostic information. CPET is based on the investigation of respiratory system, cardiovascular system and cellular response to exercise performed under controlled metabolic conditions.
Time frame: Change from baseline FVC at 8th week
FVC is going to be measured with spirometry. Spirometry is the most frequently used measure of lung function and is a measure of volume against time.
Time frame: Change from baseline FEV1 at 8th week
FEV1 is going to be measured with spirometry. Spirometry is the most frequently used measure of lung function and is a measure of volume against time.
Izmir Katip Celebi University
Other
Investigation of the Effects of Inspiratory Muscle Training on Respiratory Muscle Strength, Respiratory Functions and Aerobic Exercise Capacity in Children With Juvenile Idiopathic Arthritis: A Single-Blind Randomized Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06193681
Arthritis, Arthritis, Juvenile
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06356350
Arthritis, Arthritis, Juvenile
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT04671524
Arthritis, Arthritis, Juvenile
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT03731520
Arthritis, Arthritis, Juvenile
Istanbul, Turkey (Türkiye)
View Trial Details