- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05231057
Impact of Pilates Exercise in Children With Juvenile Idiopathic Arthritis (Arthritis)
March 26, 2022 updated by: Maged Basha, Qassim University
Impact of Clinical Pilates Exercise on Pain, Cardiorespiratory Fitness, Functional Ability, And Quality of Life in Children With Polyarticular Juvenile Idiopathic Arthritis
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Riyadh
-
Al-Kharj, Riyadh, Saudi Arabia, 11432
- Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
Patients in the study group received Pilates exercises plus conventional physical therapy program
|
Mat, Pilates band or elastic bands, and Pilate's ball
Other Names:
pain relief, increasing flexibility, and mobility, improving muscle strength
Other Names:
|
|
Experimental: control group
Patients in the control group received conventional physical therapy
|
pain relief, increasing flexibility, and mobility, improving muscle strength
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain assessment
Time Frame: at baseline
|
measured using visual analog scale.
A score of zero means no pain, while a score often means significant pain.
|
at baseline
|
|
Pain assessment
Time Frame: after 12 weeks
|
measured using visual analog scale.
A score of zero means no pain, while a score often means significant pain.
|
after 12 weeks
|
|
Cardiorespiratory fitness assessment
Time Frame: at baseline
|
assessed using electromagnetic cycle ergometer with electronic braking
|
at baseline
|
|
Cardiorespiratory fitness assessment
Time Frame: after 12 weeks
|
assessed using electromagnetic cycle ergometer with electronic braking
|
after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional ability assessment
Time Frame: at baseline
|
assessed using The Childhood Health Assessment Questionnaire
|
at baseline
|
|
Functional ability assessment
Time Frame: after 12 weeks
|
assessed using The Childhood Health Assessment Questionnaire
|
after 12 weeks
|
|
health-related quality of life
Time Frame: at baseline
|
assessed using The self-report Pediatric Quality of Life Inventory
|
at baseline
|
|
health-related quality of life
Time Frame: after 12 weeks
|
assessed using The self-report Pediatric Quality of Life Inventory
|
after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Alshimaa Azab, PhD, Cairo University
- Study Director: Maged Basha, PhD, Qassim University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1590/s1806-37132014000500008.
- Oen K, Duffy CM, Tse SM, Ramsey S, Ellsworth J, Chedeville 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 KN, Boire G, Haddad E, Houghton K, Laxer R, Turvey SE, Miettunen P, Gross K, Guzman J, Benseler S, Feldman BM, Espinosa V, Yeung RS, Tucker L. Early outcomes and improvement of patients with juvenile idiopathic arthritis enrolled in a Canadian multicenter inception cohort. Arthritis Care Res (Hoboken). 2010 Apr;62(4):527-36. doi: 10.1002/acr.20044.
- 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. Arthritis Care Res (Hoboken). 2012 May;64(5):694-703. doi: 10.1002/acr.21609.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
July 25, 2021
Study Completion (Actual)
December 5, 2021
Study Registration Dates
First Submitted
January 28, 2022
First Submitted That Met QC Criteria
January 28, 2022
First Posted (Actual)
February 9, 2022
Study Record Updates
Last Update Posted (Actual)
April 6, 2022
Last Update Submitted That Met QC Criteria
March 26, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHPT/0020/0035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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