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NCT Number: NCT03858504

Yoga Versus Home Exercise Program in Children With Enthesitis Related Arthritis

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

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Key information

Conditions

Enthesitis Related Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University, Faculty of Medicine, Nevvar Salih Isgoren Children's Hospital, Division of Pediatric Rheumatology

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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.

Primary outcomes

  1. Change in 6 minute walking distance

    Time frame: At baseline and 8 weeks later

    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.

  2. Change in timed up and down stair test

    Time frame: At baseline and 8 weeks later

    The patients will be asked to climb and descend 13 steps and the time will be recorded.

Secondary outcomes

  1. Change in Quality of Life

    Time frame: At baseline and 8 weeks later

    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.

  2. Change in Pain

    Time frame: At baseline and 8 weeks later

    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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Collaborators

  • Dokuz Eylul University
  • Izmir Katip Celebi University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2019
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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