Yoga Versus Home Exercise Program in Children With Enthesitis Related Arthritis

Enthesitis Related Arthritis Clinical Trial

Official title:

The Comparison of the Effects of Yoga and Home Exercise Program in Children With Enthesitis Related Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858504
• Other study ID #: YOGAERA
• Status: Completed
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2020
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effectiveness of different exercises programs as 'Yoga' and 'Home Exercise' in Enthesitis Related Arthritis.

Description:

Enthesitis is the localized inflammation in the attachments of muscles, ligaments, fascia to bone. Enthesitis related arthritis is a sub-form of Juvenile Idiopathic Arthritis (JIA) and primarily lower extremities, spine, and sacroiliac joints. In the literature, exercise therapy is found beneficial to improve bone density, muscle strength and functionality without leading adverse effects in these children.

Recently yoga has emerged as a new exercise approach which consist of both physical an mental components to improve self-awareness and mindfulness. However, the effects of yoga did not investigated in JIA patients. The only evidence is a case study which reports improvements in pain and stiffness in a child with JIA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Being between 13-18 years

2. Having a diagnosis of enthesitis related arthritis

3. Having a diagnosis at least 6 months ago

4. Being able to understand exercise instructions

5. Consent of family and the patient

Exclusion Criteria:

1. Any contraindication to perform exercise (neurological, cardiovascular etc.)

2. Change in medication

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Enthesitis Related Arthritis
• Enthesopathy

Intervention

Other:
• Exercise
The children with enthesitis related arthritis will be randomized into one of the exercise groups as yoga or home exercises and will perform the exercise program for 2 times a week for 8 weeks according to their groups.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University, Faculty of Medicine, Nevvar Salih Isgoren Children's Hospital, Division of Pediatric Rheumatology	Izmir

Sponsors (3)

Lead Sponsor	Collaborator
Pamukkale University	Dokuz Eylul University, Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

References & Publications (13)

Bacon MC, Nicholson C, Binder H, White PH. Juvenile rheumatoid arthritis. Aquatic exercise and lower-extremity function. Arthritis Care Res. 1991 Jun;4(2):102-5. — View Citation

Ebnezar J, Nagarathna R, Yogitha B, Nagendra HR. Effects of an integrated approach of hatha yoga therapy on functional disability, pain, and flexibility in osteoarthritis of the knee joint: a randomized controlled study. J Altern Complement Med. 2012 May;18(5):463-72. doi: 10.1089/acm.2010.0320. Epub 2012 Apr 26. — View Citation

Feinstein AB, Cohen LL, Masuda A, Griffin AT, Gamwell KL, Stiles MT, Angeles-Han ST, Prahalad S. Yoga Intervention for an Adolescent With Juvenile Idiopathic Arthritis: A Case Study. Adv Mind Body Med. 2018 Winter;32(1):13-20. — View Citation

Galantino ML, Galbavy R, Quinn L. Therapeutic effects of yoga for children: a systematic review of the literature. Pediatr Phys Ther. 2008 Spring;20(1):66-80. doi: 10.1097/PEP.0b013e31815f1208. Review. — View Citation

Haaz S, Bartlett SJ. Yoga for arthritis: a scoping review. Rheum Dis Clin North Am. 2011 Feb;37(1):33-46. doi: 10.1016/j.rdc.2010.11.001. Epub 2010 Dec 3. Review. — View 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. — View Citation

Jensen MP, McFarland CA. Increasing the reliability and validity of pain intensity measurement in chronic pain patients. Pain. 1993 Nov;55(2):195-203. — View Citation

Kirchheimer JC, Wanivenhaus A, Engel A. Does sport negatively influence joint scores in patients with juvenile rheumatoid arthritis. An 8-year prospective study. Rheumatol Int. 1993;12(6):239-42. — View Citation

Kuntze G, Nesbitt C, Whittaker JL, Nettel-Aguirre A, Toomey C, Esau S, Doyle-Baker PK, Shank J, Brooks J, Benseler S, Emery CA. Exercise Therapy in Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Jan;99(1):178-193.e1. doi: 10.1016/j.apmr.2017.05.030. Epub 2017 Jul 18. Review. — View Citation

Lelieveld OT, Takken T, van der Net J, van Weert E. Validity of the 6-minute walking test in juvenile idiopathic arthritis. Arthritis Rheum. 2005 Apr 15;53(2):304-7. — View Citation

Tarakci E, Baydogan SN, Kasapcopur O, Dirican A. Cross-cultural adaptation, reliability, and validity of the Turkish version of PedsQL 3.0 Arthritis Module: a quality-of-life measure for patients with juvenile idiopathic arthritis in Turkey. Qual Life Res. 2013 Apr;22(3):531-6. doi: 10.1007/s11136-012-0180-0. Epub 2012 Apr 29. — View Citation

Tarakci E, Yeldan I, Baydogan SN, Olgar S, Kasapcopur O. Efficacy of a land-based home exercise programme for patients with juvenile idiopathic arthritis: a randomized, controlled, single-blind study. J Rehabil Med. 2012 Nov;44(11):962-7. doi: 10.2340/16501977-1051. — View Citation

Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6 minute walking distance	Six minute walking distance will be used for determining the functional status of lower extremity. The test will be performed in a 15-m corridor. The patient will be asked to walk as fast as possible without running. Standard instructions will be used for motivation. The patients will be allowed to stop if they want without stopping the chronometer. The total distance will be measured at the end of six minutes.	At baseline and 8 weeks later
Primary	Change in timed up and down stair test	The patients will be asked to climb and descend 13 steps and the time will be recorded.	At baseline and 8 weeks later
Secondary	Change in Quality of Life	Pediatric Quality of Life (PedsQL) 3.0 Arthritis Module will be used to assess the quality of life of the patients and their parents.It is a 22-item measure consisting of 5 scales: pain and hurt, daily activities, treatment, worry, and communication. Items are rated on a 5-point Likert scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Often, 4 = Almost Always). The possible range of scores is 0-88 by summing subscale scores and lower scores indicates better quality of life.	At baseline and 8 weeks later
Secondary	Change in Pain	Numeric Rating Pain Scale will be used to assess pain severity. It has 11 points (0-10) where 0 represents no pain and 10 represents extreme pain.	At baseline and 8 weeks later