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Inspiratory Muscle Training in Juvenile Idiopathic Arthritis

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory muscle training (IMT)
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Respiratory muscles, exercise, physiotherapy, respiratory muscle training

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Izmir Katip Celebi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

No new interventions will be given to control group.

Outcomes

Primary Outcome Measures

Maximal inspiratory pressure (PImax)
Maximal inspiratory pressure (PImax) is the highest subatmospheric pressure achieved when inspiring against a closed airway.

Secondary Outcome Measures

Maximal expiratory pressure (PEmax)
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)
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)
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)
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.

Full Information

First Posted
July 1, 2022
Last Updated
September 26, 2023
Sponsor
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT05482633
Brief Title
Inspiratory Muscle Training in Juvenile Idiopathic Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Respiratory muscles, exercise, physiotherapy, respiratory muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
An independent assessor who is unaware of the group of participants going to perform all evaluations.
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Experimental group is going to perform inspiratory muscle training exercises everyday for 8 weeks.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No new interventions will be given to control group.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training (IMT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal inspiratory pressure (PImax)
Description
Maximal inspiratory pressure (PImax) is the highest subatmospheric pressure achieved when inspiring against a closed airway.
Time Frame
Change from baseline PImax at 8th week
Secondary Outcome Measure Information:
Title
Maximal expiratory pressure (PEmax)
Description
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 PEmax at 8th week
Title
Maximal Oxygen Consumption (VO2max)
Description
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 VO2max at 8th week
Title
Forced Vital Capacity (FVC)
Description
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 FVC at 8th week
Title
Forced Expiratory Volume in one second (FEV1)
Description
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.
Time Frame
Change from baseline FEV1 at 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Izmir Katip Celebi University
City
İzmir
ZIP/Postal Code
35620
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
26768831
Citation
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Results Reference
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20658239
Citation
Alkady EA, Helmy HA, Mohamed-Hussein AA. Assessment of cardiac and pulmonary function in children with juvenile idiopathic arthritis. Rheumatol Int. 2012 Jan;32(1):39-46. doi: 10.1007/s00296-010-1548-5. Epub 2010 Jul 24.
Results Reference
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PubMed Identifier
9448237
Citation
Noyes BE, Albers GM, deMello DE, Rubin BK, Moore TL. Early onset of pulmonary parenchymal disease associated with juvenile rheumatoid arthritis. Pediatr Pulmonol. 1997 Dec;24(6):444-6. doi: 10.1002/(sici)1099-0496(199712)24:63.0.co;2-8. No abstract available.
Results Reference
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PubMed Identifier
10543271
Citation
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Results Reference
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PubMed Identifier
9672993
Citation
Camiciottoli G, Trapani S, Castellani W, Ginanni R, Ermini M, Falcini F. Effect on lung function of methotrexate and non-steroid anti-inflammatory drugs in children with juvenile rheumatoid arthritis. Rheumatol Int. 1998;18(1):11-6. doi: 10.1007/s002960050047.
Results Reference
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PubMed Identifier
7794985
Citation
Henderson CJ, Lovell DJ, Specker BL, Campaigne BN. Physical activity in children with juvenile rheumatoid arthritis: quantification and evaluation. Arthritis Care Res. 1995 Jun;8(2):114-9. doi: 10.1002/art.1790080210.
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Citation
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Citation
van Brussel M, Lelieveld OT, van der Net J, Engelbert RH, Helders PJ, Takken T. Aerobic and anaerobic exercise capacity in children with juvenile idiopathic arthritis. Arthritis Rheum. 2007 Aug 15;57(6):891-7. doi: 10.1002/art.22893.
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Inspiratory Muscle Training in Juvenile Idiopathic Arthritis

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