NCT05231057

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

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

Study Start

First participant enrolled

August 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

January 28, 2022

Last Update Submit

March 26, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain assessment

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

    at baseline

  • Pain assessment

    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

    assessed using electromagnetic cycle ergometer with electronic braking

    at baseline

  • Cardiorespiratory fitness assessment

    assessed using electromagnetic cycle ergometer with electronic braking

    after 12 weeks

Secondary Outcomes (4)

  • Functional ability assessment

    at baseline

  • Functional ability assessment

    after 12 weeks

  • health-related quality of life

    at baseline

  • health-related quality of life

    after 12 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

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

Other: Pilates exercisesOther: Conventional physical therapy program

control group

EXPERIMENTAL

Patients in the control group received conventional physical therapy

Other: Conventional physical therapy program

Interventions

Mat, Pilates band or elastic bands, and Pilate's ball

Also known as: Pilates band
experimental group

pain relief, increasing flexibility, and mobility, improving muscle strength

Also known as: pain reliving modalities, stretching exercises
control groupexperimental group

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Polyarticular JIA per the International League of Associations for Rheumatology classification.
  • Age ranges from 10 to14 years.
  • Stable medical treatment.

You may not qualify if:

  • If they had contractures.
  • Congenital anomalies.
  • History of surgery.
  • History of systemic disease
  • Cardiorespiratory co-morbidity.
  • Participation in regular exercises or sports activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

Al Kharj, Riyadh Region, 11432, Saudi Arabia

Location

Related 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. doi: 10.1590/s1806-37132014000500008.

    PMID: 25410840BACKGROUND
  • 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.

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Alshimaa Azab, PhD

    Cairo University

    STUDY CHAIR
  • Maged Basha, PhD

    Qassim University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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.

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 9, 2022

Study Start

August 1, 2020

Primary Completion

July 25, 2021

Study Completion

December 5, 2021

Last Updated

April 6, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations