NCT03858504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

July 31, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

Same day

First QC Date

February 27, 2019

Last Update Submit

May 8, 2020

Conditions

Keywords

yogahome exercisesjuvenile idiopathic arthritis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Change in Quality of Life

    At baseline and 8 weeks later

  • Change in Pain

    At baseline and 8 weeks later

Study Arms (2)

Yoga Group

EXPERIMENTAL

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

Home Exercise Group

ACTIVE COMPARATOR

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

Interventions

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 GroupYoga Group

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Any contraindication to perform exercise (neurological, cardiovascular etc.)
  • Change in medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Izmir, Turkey (Türkiye)

Location

Related Publications (13)

  • 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.

    PMID: 7794985BACKGROUND
  • 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.

    PMID: 8484096BACKGROUND
  • 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.

    PMID: 11188589BACKGROUND
  • 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.

    PMID: 23027068BACKGROUND
  • 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.

    PMID: 28729171BACKGROUND
  • 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.

    PMID: 29406303BACKGROUND
  • 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.

    PMID: 21220084BACKGROUND
  • 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.

    PMID: 22537508BACKGROUND
  • 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.

    PMID: 8309709BACKGROUND
  • 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.

    PMID: 15818658BACKGROUND
  • 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.

    PMID: 17057533BACKGROUND
  • 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.

    PMID: 22544413BACKGROUND
  • 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.

    PMID: 18300936BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Erdogan Kavlak, PhD

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT.

Study Record Dates

First Submitted

February 27, 2019

First Posted

February 28, 2019

Study Start

July 31, 2019

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations