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Impact of Pilates Exercise in Children With Juvenile Idiopathic Arthritis

Sponsor
Qassim University (Other)
Overall Status
Completed
CT.gov ID
NCT05231057
Collaborator
Cairo University (Other), Prince Sattam Bin Abdulaziz University (Other)
40
Enrollment
1
Location
2
Arms
16.1
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pilates exercises
  • Other: Conventional physical therapy program
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Clinical Pilates Exercise on Pain, Cardiorespiratory Fitness, Functional Ability, And Quality of Life in Children With Polyarticular Juvenile Idiopathic Arthritis
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Jul 25, 2021
Actual Study Completion Date :
Dec 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

Patients in the study group received Pilates exercises plus conventional physical therapy program

Other: Pilates exercises
Mat, Pilates band or elastic bands, and Pilate's ball
Other Names:
  • Pilates band

    • Other: Conventional physical therapy program
    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

    Other: Conventional physical therapy program
    pain relief, increasing flexibility, and mobility, improving muscle strength
    Other Names:
  • pain reliving modalities, stretching exercises

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain assessment [at baseline]

      measured using visual analog scale. A score of zero means no pain, while a score often means significant pain.

    2. Pain assessment [after 12 weeks]

      measured using visual analog scale. A score of zero means no pain, while a score often means significant pain.

    3. Cardiorespiratory fitness assessment [at baseline]

      assessed using electromagnetic cycle ergometer with electronic braking

    4. Cardiorespiratory fitness assessment [after 12 weeks]

      assessed using electromagnetic cycle ergometer with electronic braking

    Secondary Outcome Measures

    1. Functional ability assessment [at baseline]

      assessed using The Childhood Health Assessment Questionnaire

    2. Functional ability assessment [after 12 weeks]

      assessed using The Childhood Health Assessment Questionnaire

    3. health-related quality of life [at baseline]

      assessed using The self-report Pediatric Quality of Life Inventory

    4. health-related quality of life [after 12 weeks]

      assessed using The self-report Pediatric Quality of Life Inventory

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University Al-Kharj Riyadh Saudi Arabia 11432

    Sponsors and Collaborators

    • Qassim University
    • Cairo University
    • Prince Sattam Bin Abdulaziz University

    Investigators

    • Study Chair: Alshimaa Azab, PhD, Cairo University
    • Study Director: Maged Basha, PhD, Qassim University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maged Basha, Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt., Qassim University
    ClinicalTrials.gov Identifier:
    NCT05231057
    Other Study ID Numbers:
    • RHPT/0020/0035
    First Posted:
    Feb 9, 2022
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Juvenile

    Study Results

    No Results Posted as of Apr 6, 2022