Yoga Versus Home Exercise Program in Children With Enthesitis Related Arthritis

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

Detailed Description
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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.

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

Conditions
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Enthesitis Related Arthritis

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being between 13-18 years Having a diagnosis of enthesitis related arthritis Having a diagnosis at least 6 months ago Being able to understand exercise instructions Consent of family and the patient Exclusion Criteria: Any contraindication to perform exercise (neurological, cardiovascular etc.) Change in medication

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Group<br>The yoga program will include breathing exercises, different postures, and meditation. The yoga will be performed in groups. The program will be supervised a physical therapist for two times in a week for eight weeks . A session will be fifty minutes (5-10 minutes: warming-up, 20-25 minutes: postures, 10-15 minutes: cooling down). | Other: Exercise<br>* 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.<br>|
| Active Comparator: Home Exercise Group<br>Home exercise program will consist of trunk strengthening exercises. The patients will be asked to check the exercise days. Patients will be contacted with telephone once a week. | Other: Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yoga, home exercises, juvenile idiopathic arthritis