Juvenile ArthritisArthritisNCT05231057
Impact of Pilates Exercise in Children With Juvenile Idiopathic Arthritis
A study testing Pilates exercises and Conventional physical therapy program in people with Juvenile Arthritis and Cardiorespiratory Fitness, run by Qassim University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Juvenile Arthritis, Cardiorespiratory Fitness, Quality of Life
- What is being tested?
- Pilates exercises and Conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2020to 5 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Polyarticular JIA per the International League of Associations for Rheumatology classification.
- Age ranges from 10 to14 years.
- Stable medical treatment.
Who cannot join
- If they had contractures.
- Congenital anomalies.
- History of surgery.
- History of systemic disease
- Cardiorespiratory co-morbidity.
- Participation in regular exercises or sports activity.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
Al Kharj, Riyadh Region, 11432
About this study
Official title: 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.
Read the 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.
- Being tested
- Pilates exercises, Conventional physical therapy program
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Also called Pilates band
Mat, Pilates band or elastic bands, and Pilate's ball
Conventional physical therapy programOther
Also called pain reliving modalities, stretching exercises
pain relief, increasing flexibility, and mobility, improving muscle strength
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients in the study group received Pilates exercises plus conventional physical therapy program Receives: Other: Pilates exercises; Other: Conventional physical therapy program |
| control group | Experimental | Patients in the control group received conventional physical therapy Receives: Other: Conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
measured using visual analog scale. A score of zero means no pain, while a score often means significant pain.
Measured: at baseline
Pain assessment
measured using visual analog scale. A score of zero means no pain, while a score often means significant pain.
Measured: after 12 weeks
Cardiorespiratory fitness assessment
assessed using electromagnetic cycle ergometer with electronic braking
Measured: at baseline
Cardiorespiratory fitness assessment
assessed using electromagnetic cycle ergometer with electronic braking
Measured: after 12 weeks
Secondary outcomes (4)
Functional ability assessment
assessed using The Childhood Health Assessment Questionnaire
Measured: at baseline
Functional ability assessment
assessed using The Childhood Health Assessment Questionnaire
Measured: after 12 weeks
health-related quality of life
assessed using The self-report Pediatric Quality of Life Inventory
Measured: at baseline
health-related quality of life
assessed using The self-report Pediatric Quality of Life Inventory
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Aug 2020
- Primary completion25 Jul 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Juvenile ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- Alshimaa Azab, PhD, Study chair, Cairo UniversityMaged Basha, PhD, Study director, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231057
- Sponsor's protocol ID
- RHPT/0020/0035
- Acronym
- Arthritis
- Status last verified
- Mar 2022
- First submitted
- 28 Jan 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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.
PubMed 25410840Oen 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.
PubMed 20391508Haverman 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.
PubMed 22238240
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Pilates Exercise on Pain, Cardiorespiratory Fitness, Functional Ability, And Quality of Life in Children With Polyarticular Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05231057
- Acronym / sponsor ID
- Arthritis / RHPT/0020/0035
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Pilates exercises, Other: Conventional physical therapy programPatients in the study group received Pilates exercises plus conventional physical therapy program |
| control group | Experimental | Other: Conventional physical therapy programPatients in the control group received conventional physical therapy |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Polyarticular JIA per the International League of Associations for Rheumatology classification.
- Age ranges from 10 to14 years.
- Stable medical treatment.
Key exclusion criteria (6 listed)
- If they had contractures.
- Congenital anomalies.
- History of surgery.
- History of systemic disease
- Cardiorespiratory co-morbidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates exercisesAlso: Pilates bandMat, Pilates band or elastic bands, and Pilate's ball | Other | experimental group |
| Conventional physical therapy programAlso: pain reliving modalities, stretching exercisespain relief, increasing flexibility, and mobility, improving muscle strength | Other | control group, experimental group |
Primary outcome
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.
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.
Cardiorespiratory fitness assessment
Time frame: at baseline
assessed using electromagnetic cycle ergometer with electronic braking
Cardiorespiratory fitness assessment
Time frame: after 12 weeks
assessed using electromagnetic cycle ergometer with electronic braking
4 secondary outcomes
Functional ability assessment
Time frame: at baseline
Functional ability assessment
Time frame: after 12 weeks
health-related quality of life
Time frame: at baseline
health-related quality of life
Time frame: after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Background: PubMed 25410840Franco 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 publication: PubMed 20391508Oen 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 publication: PubMed 22238240Haverman 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.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alshimaa Azab, PhD study chair
Cairo University
Maged Basha, PhD study director
Qassim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises and Conventional physical therapy program in people with Juvenile Arthritis and Cardiorespiratory Fitness, run by Qassim University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05231057, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.