Inspiratory Muscle Training in Juvenile Idiopathic Arthritis

Sponsor

Izmir Katip Celebi University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05482633

Collaborator

(none)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Juvenile Idiopathic Arthritis	Other: Inspiratory muscle training (IMT)	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

An independent assessor who is unaware of the group of participants going to perform all evaluations.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Sep 15, 2022

Anticipated Study Completion Date :

Sep 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Experimental group is going to perform inspiratory muscle training exercises everyday for 8 weeks.	Other: Inspiratory muscle training (IMT) 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.
No Intervention: Control Group No new interventions will be given to control group.

Arm

Intervention/Treatment

Experimental: Intervention Group

Experimental group is going to perform inspiratory muscle training exercises everyday for 8 weeks.

Other: Inspiratory muscle training (IMT)

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.

No Intervention: Control Group

No new interventions will be given to control group.

Outcome Measures

Primary Outcome Measures

Maximal inspiratory pressure (PImax) [Change from baseline PImax at 8th week]
Maximal inspiratory pressure (PImax) is the highest subatmospheric pressure achieved when inspiring against a closed airway.

Secondary Outcome Measures

Maximal expiratory pressure (PEmax) [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.
Maximal Oxygen Consumption (VO2max) [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.
Forced Vital Capacity (FVC) [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.
Forced Expiratory Volume in one second (FEV1) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Being diagnosed with JIA according to International League of Associations of Rheumatology (ILAR) criteria by a specialist pediatric rheumatologist.
Being between the ages of 13-18.
To be able to understand and speak the Turkish language adequately.
Being on the same biological agent treatment for the last three months.
Agreeing to participate in the research.
The patient's family accepts the child's participation in the study.
Having a history of arthritis in at least one joint in lower extremities.

Exclusion Criteria:

Presence of a condition that prevents performing respiratory muscle training therapy
Being involved in a different physiotherapy and rehabilitation program six months before the start of the study
Having a regular exercise habit during last six months (applying a structured exercise program at least 3 days a week)
Presence of a different pathology that may affect cardiovascular fitness, pulmonary capacity, walking capacity or quality of life.
Being diagnosed with systemic JIA clinical subtype.