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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05231057
Other study ID # RHPT/0020/0035
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date December 5, 2021

Study information

Verified date March 2022
Source Qassim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Juvenile idiopathic arthritis (JIA) is one of the most common chronic childhood inflammatory diseases that is characterized by permanent joint inflammation attributable to immune system disturbance.


Description:

Therapeutic exercises play an essential role as a non-pharmacologic treatment for children with JIA. It has effectively been used to reduce pain, improve muscular function, increase physical activity and promote quality of life in children with chronic musculoskeletal disorders. Clinical Pilates exercise is usually perceived as enjoyable activity by children with JIA, thereby, it can help them be more active for extended periods without causing discomfort while also allowing them to control their breathing and avoid becoming fatigued.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 5, 2021
Est. primary completion date July 25, 2021
Accepts healthy volunteers No
Gender All
Age group 10 Years to 14 Years
Eligibility Inclusion Criteria: - Polyarticular JIA per the International League of Associations for Rheumatology classification. - Age ranges from 10 to14 years. - Stable medical treatment. Exclusion Criteria: - If they had contractures. - Congenital anomalies. - History of surgery. - History of systemic disease - Cardiorespiratory co-morbidity. - Participation in regular exercises or sports activity.

Study Design


Intervention

Other:
Pilates exercises
Mat, Pilates band or elastic bands, and Pilate's ball
Conventional physical therapy program
pain relief, increasing flexibility, and mobility, improving muscle strength

Locations

Country Name City State
Saudi Arabia Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University Al-Kharj Riyadh

Sponsors (3)

Lead Sponsor Collaborator
Qassim University Cairo University, Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

Franco CB, Ribeiro AF, Morcillo AM, Zambon MP, Almeida MB, Rozov T. Air stacking: effects of Pilates mat exercises on muscle strength and on pulmonary function in patients with cystic fibrosis. J Bras Pneumol. 2014 Oct;40(5):521-7. English, Portuguese. — View Citation

Haverman L, Grootenhuis MA, van den Berg JM, van Veenendaal M, Dolman KM, Swart JF, Kuijpers TW, van Rossum MA. Predictors of health-related quality of life in children and adolescents with juvenile idiopathic arthritis: results from a Web-based survey. A — View Citation

Oen K, Duffy CM, Tse SM, Ramsey S, Ellsworth J, Chédeville G, Chetaille AL, Saint-Cyr C, Cabral DA, Spiegel LR, Schneider R, Lang B, Huber AM, Dancey P, Silverman E, Rosenberg AM, Cameron B, Johnson N, Dorval J, Scuccimarri R, Campillo S, Petty RE, Duffy — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain assessment measured using visual analog scale. A score of zero means no pain, while a score often means significant pain. at baseline
Primary Pain assessment measured using visual analog scale. A score of zero means no pain, while a score often means significant pain. after 12 weeks
Primary Cardiorespiratory fitness assessment assessed using electromagnetic cycle ergometer with electronic braking at baseline
Primary Cardiorespiratory fitness assessment assessed using electromagnetic cycle ergometer with electronic braking after 12 weeks
Secondary Functional ability assessment assessed using The Childhood Health Assessment Questionnaire at baseline
Secondary Functional ability assessment assessed using The Childhood Health Assessment Questionnaire after 12 weeks
Secondary health-related quality of life assessed using The self-report Pediatric Quality of Life Inventory at baseline
Secondary health-related quality of life assessed using The self-report Pediatric Quality of Life Inventory after 12 weeks
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