Enthesitis Related Arthritis Clinical Trial
Official title:
The Comparison of the Effects of Yoga and Home Exercise Program in Children With Enthesitis Related Arthritis
NCT number | NCT03858504 |
Other study ID # | YOGAERA |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 31, 2019 |
Est. completion date | July 31, 2019 |
Verified date | May 2020 |
Source | Pamukkale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to compare the effectiveness of different exercises programs as 'Yoga' and 'Home Exercise' in Enthesitis Related Arthritis.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Dokuz Eylul University, Faculty of Medicine, Nevvar Salih Isgoren Children's Hospital, Division of Pediatric Rheumatology | Izmir |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University | Dokuz Eylul University, Izmir Katip Celebi University |
Turkey,
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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
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* Note: There are 13 references in all — Click here to view all references
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 |
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