Yoga Versus Home Exercise Program in Children With Enthesitis Related Arthritis

Sponsor
Pamukkale University (Other)
Overall Status
Completed
CT.gov ID
NCT03858504
Collaborator
Dokuz Eylul University (Other), Izmir Katip Celebi University (Other)
21
1
2

Study Details

Study Description

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
  • Other: Exercise
N/A

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

Study Type:
Interventional
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 :
Jul 31, 2019
Actual Primary Completion Date :
Jul 31, 2019
Actual Study Completion Date :
Jul 31, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. Change in 6 minute walking distance [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 [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 [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 [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

Criteria

Ages Eligible for Study:
13 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

  • Study Director: Erdogan Kavlak, PhD, Pamukkale University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ezgi Yaşar, PT., Pamukkale University
ClinicalTrials.gov Identifier:
NCT03858504
Other Study ID Numbers:
  • YOGAERA
First Posted:
Feb 28, 2019
Last Update Posted:
May 12, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ezgi Yaşar, PT., Pamukkale University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2020