Yoga Versus Home Exercise Program in Children With Enthesitis Related Arthritis

NCT ID: NCT03858504

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Enthesitis Related Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Exercise

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role collaborator

Izmir Katip Celebi University

OTHER

Sponsor Role collaborator

Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Ezgi Yaşar

PT.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erdogan Kavlak, PhD

Role: STUDY_DIRECTOR

Pamukkale University

Locations

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

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 7794985 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8484096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11188589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23027068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28729171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29406303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21220084 (View on PubMed)

Ebnezar J, Nagarathna R, Yogitha B, Nagendra HR. Effects of an integrated approach of hatha yoga therapy on functional disability, pain, and flexibility in osteoarthritis of the knee joint: a randomized controlled study. J Altern Complement Med. 2012 May;18(5):463-72. doi: 10.1089/acm.2010.0320. Epub 2012 Apr 26.

Reference Type BACKGROUND
PMID: 22537508 (View on PubMed)

Jensen MP, McFarland CA. Increasing the reliability and validity of pain intensity measurement in chronic pain patients. Pain. 1993 Nov;55(2):195-203. doi: 10.1016/0304-3959(93)90148-I.

Reference Type BACKGROUND
PMID: 8309709 (View on PubMed)

Lelieveld OT, Takken T, van der Net J, van Weert E. Validity of the 6-minute walking test in juvenile idiopathic arthritis. Arthritis Rheum. 2005 Apr 15;53(2):304-7. doi: 10.1002/art.21086. No abstract available.

Reference Type BACKGROUND
PMID: 15818658 (View on PubMed)

Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. doi: 10.1097/01.PEP.0000127564.08922.6A.

Reference Type BACKGROUND
PMID: 17057533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22544413 (View on PubMed)

Galantino ML, Galbavy R, Quinn L. Therapeutic effects of yoga for children: a systematic review of the literature. Pediatr Phys Ther. 2008 Spring;20(1):66-80. doi: 10.1097/PEP.0b013e31815f1208.

Reference Type BACKGROUND
PMID: 18300936 (View on PubMed)

Other Identifiers

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YOGAERA

Identifier Type: -

Identifier Source: org_study_id

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