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Yoga Versus Home Exercise Program in Children With Enthesitis Related Arthritis

Primary Purpose

Enthesitis Related Arthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enthesitis Related Arthritis focused on measuring yoga, home exercises, juvenile idiopathic arthritis

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga Group

Home Exercise Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 27, 2019
Last Updated
May 8, 2020
Sponsor
Pamukkale University
Collaborators
Dokuz Eylul University, Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT03858504
Brief Title
Yoga Versus Home Exercise Program in Children With Enthesitis Related Arthritis
Official Title
The Comparison of the Effects of Yoga and Home Exercise Program in Children With Enthesitis Related Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
Collaborators
Dokuz Eylul University, Izmir Katip Celebi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enthesitis Related Arthritis
Keywords
yoga, home exercises, juvenile idiopathic arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Home Exercise Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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 Outcome Measure Information:
Title
Change in 6 minute walking distance
Description
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.
Time Frame
At baseline and 8 weeks later
Title
Change in timed up and down stair test
Description
The patients will be asked to climb and descend 13 steps and the time will be recorded.
Time Frame
At baseline and 8 weeks later
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
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.
Time Frame
At baseline and 8 weeks later
Title
Change in Pain
Description
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.
Time Frame
At baseline and 8 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erdogan Kavlak, PhD
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylul University, Faculty of Medicine, Nevvar Salih Isgoren Children's Hospital, Division of Pediatric Rheumatology
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7794985
Citation
Henderson CJ, Lovell DJ, Specker BL, Campaigne BN. Physical activity in children with juvenile rheumatoid arthritis: quantification and evaluation. Arthritis Care Res. 1995 Jun;8(2):114-9. doi: 10.1002/art.1790080210.
Results Reference
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8484096
Citation
Kirchheimer JC, Wanivenhaus A, Engel A. Does sport negatively influence joint scores in patients with juvenile rheumatoid arthritis. An 8-year prospective study. Rheumatol Int. 1993;12(6):239-42. doi: 10.1007/BF00301009.
Results Reference
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PubMed Identifier
11188589
Citation
Bacon MC, Nicholson C, Binder H, White PH. Juvenile rheumatoid arthritis. Aquatic exercise and lower-extremity function. Arthritis Care Res. 1991 Jun;4(2):102-5. doi: 10.1002/art.1790040207.
Results Reference
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PubMed Identifier
23027068
Citation
Tarakci E, Yeldan I, Baydogan SN, Olgar S, Kasapcopur O. Efficacy of a land-based home exercise programme for patients with juvenile idiopathic arthritis: a randomized, controlled, single-blind study. J Rehabil Med. 2012 Nov;44(11):962-7. doi: 10.2340/16501977-1051.
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PubMed Identifier
28729171
Citation
Kuntze G, Nesbitt C, Whittaker JL, Nettel-Aguirre A, Toomey C, Esau S, Doyle-Baker PK, Shank J, Brooks J, Benseler S, Emery CA. Exercise Therapy in Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Jan;99(1):178-193.e1. doi: 10.1016/j.apmr.2017.05.030. Epub 2017 Jul 18.
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Feinstein AB, Cohen LL, Masuda A, Griffin AT, Gamwell KL, Stiles MT, Angeles-Han ST, Prahalad S. Yoga Intervention for an Adolescent With Juvenile Idiopathic Arthritis: A Case Study. Adv Mind Body Med. 2018 Winter;32(1):13-20.
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Haaz S, Bartlett SJ. Yoga for arthritis: a scoping review. Rheum Dis Clin North Am. 2011 Feb;37(1):33-46. doi: 10.1016/j.rdc.2010.11.001. Epub 2010 Dec 3.
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Yoga Versus Home Exercise Program in Children With Enthesitis Related Arthritis

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