Inspiratory Muscle Training in Juvenile Idiopathic Arthritis

NCT05482633 | Completed

• 1 other identifier: IMTJIA
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Respiratory muscles; exercise; physiotherapy; respiratory muscle training

Outcome Measures

Primary Outcomes (1)

• Maximal inspiratory pressure (PImax)

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

  Change from baseline PImax at 8th week

Secondary Outcomes (4)

• Maximal expiratory pressure (PEmax)

  Change from baseline PEmax at 8th week

• Maximal Oxygen Consumption (VO2max)

  Change from baseline VO2max at 8th week

• Forced Vital Capacity (FVC)

  Change from baseline FVC at 8th week

• Forced Expiratory Volume in one second (FEV1)

  Change from baseline FEV1 at 8th week

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Inspiratory muscle training (IMT)

Control Group

NO INTERVENTION

No new interventions will be given to control group.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, 35620, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 26768831 BACKGROUND

• 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.

  PMID: 20658239 BACKGROUND

• 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.

  PMID: 9448237 BACKGROUND

• Knook 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.

  PMID: 10543271 BACKGROUND

• 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.

  PMID: 9672993 BACKGROUND

• 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.

  PMID: 7794985 BACKGROUND

• Bohr 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.

  PMID: 26653716 BACKGROUND

• 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.

  PMID: 17665476 BACKGROUND

• Bayraktar 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.

  PMID: 30430201 BACKGROUND

• McConnell 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.

  PMID: 15162248 BACKGROUND

• American 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.

  PMID: 12186831 BACKGROUND

• Dragoi 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.

  PMID: 25810425 BACKGROUND

• Basakci 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.

  PMID: 29943207 BACKGROUND

• Bissett 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.

  PMID: 32204719 BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent assessor who is unaware of the group of participants going to perform all evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: August 1, 2022
• Study Start: July 1, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

TU (1)