Juvenile Idiopathic ArthritisNCT05482633
Inspiratory Muscle Training in Juvenile Idiopathic Arthritis
A study testing Inspiratory muscle training (IMT) in people with Juvenile Idiopathic Arthritis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Inspiratory muscle training (IMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Inspiratory muscle training (IMT)
- Keywords
- Respiratory muscles, exercise, physiotherapy, respiratory muscle training
- Medical subject headings
- Arthritis, Juvenile, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training (IMT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Experimental group is going to perform inspiratory muscle training exercises everyday for 8 weeks. Receives: Other: Inspiratory muscle training (IMT) |
| Control Group | No intervention | No new interventions will be given to control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure (PImax)
Maximal inspiratory pressure (PImax) is the highest subatmospheric pressure achieved when inspiring against a closed airway.
Measured: Change from baseline PImax at 8th week
Secondary outcomes (4)
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.
Measured: Change from baseline PEmax at 8th week
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.
Measured: Change from baseline VO2max at 8th week
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.
Measured: Change from baseline FVC at 8th week
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.
Measured: Change from baseline FEV1 at 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Jul 2022
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devrim Can Sarac, PhD(c), Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482633
- Sponsor's protocol ID
- IMTJIA
- Status last verified
- Sep 2023
- First submitted
- 1 Jul 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Richardson AE, Warrier K, Vyas H. Respiratory complications of the rheumatological diseases in childhood. Arch Dis Child. 2016 Aug;101(8):752-8. doi: 10.1136/archdischild-2014-306049. Epub 2016 Jan 14.
PubMed 26768831Alkady 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.
PubMed 20658239Noyes 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.
PubMed 9448237Knook LM, de Kleer IM, van der Ent CK, van der Net JJ, Prakken BJ, Kuis W. Lung function abnormalities and respiratory muscle weakness in children with juvenile chronic arthritis. Eur Respir J. 1999 Sep;14(3):529-33. doi: 10.1034/j.1399-3003.1999.14c09.x.
PubMed 10543271Camiciottoli 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.
PubMed 9672993Henderson 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.
PubMed 7794985Bohr AH, Nielsen S, Muller K, Karup Pedersen F, Andersen LB. Reduced physical activity in children and adolescents with Juvenile Idiopathic Arthritis despite satisfactory control of inflammation. Pediatr Rheumatol Online J. 2015 Dec 10;13:57. doi: 10.1186/s12969-015-0053-5.
PubMed 26653716van 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.
PubMed 17665476Bayraktar D, Savci S, Altug-Gucenmez O, Manci E, Makay B, Ilcin N, Unsal E. The effects of 8-week water-running program on exercise capacity in children with juvenile idiopathic arthritis: a controlled trial. Rheumatol Int. 2019 Jan;39(1):59-65. doi: 10.1007/s00296-018-4209-8. Epub 2018 Nov 14.
PubMed 30430201McConnell AK, Romer LM. Respiratory muscle training in healthy humans: resolving the controversy. Int J Sports Med. 2004 May;25(4):284-93. doi: 10.1055/s-2004-815827.
PubMed 15162248American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831Dragoi RG, Amaricai E, Dragoi M, Popoviciu H, Avram C. Inspiratory muscle training improves aerobic capacity and pulmonary function in patients with ankylosing spondylitis: a randomized controlled study. Clin Rehabil. 2016 Apr;30(4):340-6. doi: 10.1177/0269215515578292. Epub 2015 Mar 25.
PubMed 25810425Basakci Calik B, Gur Kabul E, Taskin H, Telli Atalay O, Bas Aslan U, Tasci M, Bicakci F, Yildiz AI. The efficiency of inspiratory muscle training in patients with ankylosing spondylitis. Rheumatol Int. 2018 Sep;38(9):1713-1720. doi: 10.1007/s00296-018-4093-2. Epub 2018 Jun 25.
PubMed 29943207Bissett B, Gosselink R, van Haren FMP. Respiratory Muscle Rehabilitation in Patients with Prolonged Mechanical Ventilation: A Targeted Approach. Crit Care. 2020 Mar 24;24(1):103. doi: 10.1186/s13054-020-2783-0.
PubMed 32204719
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05482633
- Acronym / sponsor ID
- IMTJIA
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Respiratory muscles, exercise, physiotherapy, respiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Inspiratory muscle training (IMT)Experimental group is going to perform inspiratory muscle training exercises everyday for 8 weeks. |
| Control Group | No intervention | –No new interventions will be given to control group. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention Group |
Primary outcome
Maximal inspiratory pressure (PImax)
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.
4 secondary outcomes
Maximal expiratory pressure (PEmax)
Time frame: Change from baseline PEmax at 8th week
Maximal Oxygen Consumption (VO2max)
Time frame: Change from baseline VO2max at 8th week
Forced Vital Capacity (FVC)
Time frame: Change from baseline FVC at 8th week
Forced Expiratory Volume in one second (FEV1)
Time frame: Change from baseline FEV1 at 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 26768831Richardson AE, Warrier K, Vyas H. Respiratory complications of the rheumatological diseases in childhood. Arch Dis Child. 2016 Aug;101(8):752-8. doi: 10.1136/archdischild-2014-306049. Epub 2016 Jan 14.
- Background: PubMed 20658239Alkady 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.
- Background: PubMed 9448237Noyes 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.
- Background: PubMed 10543271Knook LM, de Kleer IM, van der Ent CK, van der Net JJ, Prakken BJ, Kuis W. Lung function abnormalities and respiratory muscle weakness in children with juvenile chronic arthritis. Eur Respir J. 1999 Sep;14(3):529-33. doi: 10.1034/j.1399-3003.1999.14c09.x.
- Background: PubMed 9672993Camiciottoli 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.
- Background: PubMed 7794985Henderson 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.
- Background: PubMed 26653716Bohr AH, Nielsen S, Muller K, Karup Pedersen F, Andersen LB. Reduced physical activity in children and adolescents with Juvenile Idiopathic Arthritis despite satisfactory control of inflammation. Pediatr Rheumatol Online J. 2015 Dec 10;13:57. doi: 10.1186/s12969-015-0053-5.
- Background: PubMed 17665476van 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.
- Background: PubMed 30430201Bayraktar D, Savci S, Altug-Gucenmez O, Manci E, Makay B, Ilcin N, Unsal E. The effects of 8-week water-running program on exercise capacity in children with juvenile idiopathic arthritis: a controlled trial. Rheumatol Int. 2019 Jan;39(1):59-65. doi: 10.1007/s00296-018-4209-8. Epub 2018 Nov 14.
- Background: PubMed 15162248McConnell AK, Romer LM. Respiratory muscle training in healthy humans: resolving the controversy. Int J Sports Med. 2004 May;25(4):284-93. doi: 10.1055/s-2004-815827.
- Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Background: PubMed 25810425Dragoi RG, Amaricai E, Dragoi M, Popoviciu H, Avram C. Inspiratory muscle training improves aerobic capacity and pulmonary function in patients with ankylosing spondylitis: a randomized controlled study. Clin Rehabil. 2016 Apr;30(4):340-6. doi: 10.1177/0269215515578292. Epub 2015 Mar 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training (IMT) in people with Juvenile Idiopathic Arthritis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (PImax) (time frame: Change from baseline PImax at 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05482633, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.