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

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:
  • Pilates band
pain relief, increasing flexibility, and mobility, improving muscle strength
Other Names:
  • pain reliving modalities, stretching exercises
Experimental: control group
Patients in the control group received conventional physical therapy
pain relief, increasing flexibility, and mobility, improving muscle strength
Other Names:
  • pain reliving modalities, stretching exercises

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.

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.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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