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Yoga Versus Home Exercise Program in Children With Enthesitis Related Arthritis

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ClinicalTrials.gov Identifier: NCT03858504
Recruitment Status : Completed
First Posted : February 28, 2019
Last Update Posted : May 12, 2020
Sponsor:
Collaborators:
Dokuz Eylul University
Izmir Katip Celebi University
Information provided by (Responsible Party):
Ezgi Yaşar, Pamukkale University

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

Condition or disease Intervention/treatment Phase
Enthesitis Related Arthritis Other: Exercise Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Comparison of the Effects of Yoga and Home Exercise Program in Children With Enthesitis Related Arthritis
Actual Study Start Date : July 31, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Yoga Group
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
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.
Active Comparator: Home Exercise Group
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
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858504


Locations
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Turkey
Dokuz Eylul University, Faculty of Medicine, Nevvar Salih Isgoren Children's Hospital, Division of Pediatric Rheumatology
Izmir, Turkey
Sponsors and Collaborators
Pamukkale University
Dokuz Eylul University
Izmir Katip Celebi University
Investigators
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Study Director: Erdogan Kavlak, PhD Pamukkale University
More Information
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Publications:

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Responsible Party: Ezgi Yaşar, PT., Pamukkale University
ClinicalTrials.gov Identifier: NCT03858504    
Other Study ID Numbers: YOGAERA
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ezgi Yaşar, Pamukkale University:
yoga
home exercises
juvenile idiopathic arthritis
Additional relevant MeSH terms:
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Arthritis
Enthesopathy
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Tendinopathy
Muscular Diseases
 Tendon Injuries
Wounds and Injuries
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases