Impact of Pilates Exercise in Children With Juvenile Idiopathic Arthritis (Arthritis)
Primary Purpose
Juvenile Arthritis, Cardiorespiratory Fitness, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Pilates exercises
Conventional physical therapy program
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Arthritis
Eligibility Criteria
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.
Sites / Locations
- Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
experimental group
control group
Arm Description
Patients in the study group received Pilates exercises plus conventional physical therapy program
Patients in the control group received conventional physical therapy
Outcomes
Primary Outcome Measures
Pain assessment
measured using visual analog scale. A score of zero means no pain, while a score often means significant pain.
Pain assessment
measured using visual analog scale. A score of zero means no pain, while a score often means significant pain.
Cardiorespiratory fitness assessment
assessed using electromagnetic cycle ergometer with electronic braking
Cardiorespiratory fitness assessment
assessed using electromagnetic cycle ergometer with electronic braking
Secondary Outcome Measures
Functional ability assessment
assessed using The Childhood Health Assessment Questionnaire
Functional ability assessment
assessed using The Childhood Health Assessment Questionnaire
health-related quality of life
assessed using The self-report Pediatric Quality of Life Inventory
health-related quality of life
assessed using The self-report Pediatric Quality of Life Inventory
Full Information
NCT ID
NCT05231057
First Posted
January 28, 2022
Last Updated
March 26, 2022
Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
1. Study Identification
Unique Protocol Identification Number
NCT05231057
Brief Title
Impact of Pilates Exercise in Children With Juvenile Idiopathic Arthritis
Acronym
Arthritis
Official Title
Impact of Clinical Pilates Exercise on Pain, Cardiorespiratory Fitness, Functional Ability, And Quality of Life in Children With Polyarticular Juvenile Idiopathic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
July 25, 2021 (Actual)
Study Completion Date
December 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Arthritis, Cardiorespiratory Fitness, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Patients in the study group received Pilates exercises plus conventional physical therapy program
Arm Title
control group
Arm Type
Experimental
Arm Description
Patients in the control group received conventional physical therapy
Intervention Type
Other
Intervention Name(s)
Pilates exercises
Other Intervention Name(s)
Pilates band
Intervention Description
Mat, Pilates band or elastic bands, and Pilate's ball
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy program
Other Intervention Name(s)
pain reliving modalities, stretching exercises
Intervention Description
pain relief, increasing flexibility, and mobility, improving muscle strength
Primary Outcome Measure Information:
Title
Pain assessment
Description
measured using visual analog scale. A score of zero means no pain, while a score often means significant pain.
Time Frame
at baseline
Title
Pain assessment
Description
measured using visual analog scale. A score of zero means no pain, while a score often means significant pain.
Time Frame
after 12 weeks
Title
Cardiorespiratory fitness assessment
Description
assessed using electromagnetic cycle ergometer with electronic braking
Time Frame
at baseline
Title
Cardiorespiratory fitness assessment
Description
assessed using electromagnetic cycle ergometer with electronic braking
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
Functional ability assessment
Description
assessed using The Childhood Health Assessment Questionnaire
Time Frame
at baseline
Title
Functional ability assessment
Description
assessed using The Childhood Health Assessment Questionnaire
Time Frame
after 12 weeks
Title
health-related quality of life
Description
assessed using The self-report Pediatric Quality of Life Inventory
Time Frame
at baseline
Title
health-related quality of life
Description
assessed using The self-report Pediatric Quality of Life Inventory
Time Frame
after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshimaa Azab, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maged Basha, PhD
Organizational Affiliation
Qassim University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
City
Al-Kharj
State/Province
Riyadh
ZIP/Postal Code
11432
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
25410840
Citation
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.
Results Reference
background
PubMed Identifier
20391508
Citation
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.
Results Reference
result
PubMed Identifier
22238240
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. Arthritis Care Res (Hoboken). 2012 May;64(5):694-703. doi: 10.1002/acr.21609.
Results Reference
result
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Impact of Pilates Exercise in Children With Juvenile Idiopathic Arthritis
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