- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06237361
Pilates Benefits in Pediatric Burn Survivors
Muscle Strength, Functional Capacity and Quality of Life Responses to Pilates Exercises in Children With Burn Injuries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research focused on examining the impact of Pilates exercises on lower limb muscle strength, functional capacity, and quality of life in children recuperating from burn injuries. The study, conducted as a twelve-week randomized clinical trial with 60 participants, found notable improvements in various aspects for the group receiving Pilates exercises alongside traditional physical therapy. Specifically, enhancements in muscle strength (including hip flexors, extensors, abductors, and more), functional capacity, and overall quality of life scores were statistically significant in the Pilates group compared to those undergoing traditional therapy alone. This suggests a positive influence of Pilates exercises on the rehabilitation of children with lower limb burns.
The investigation delved into the potential benefits of Pilates exercises, emphasizing their role in augmenting muscle strength, functional capacity, and overall well-being. The study participants, aged 10 to 15 years and recovering from lower limb burns, were randomly assigned to either a control group receiving only traditional physical therapy or a Pilates group combining Pilates exercises with traditional therapy. The outcomes demonstrated significant differences favoring the Pilates group, not only in terms of lower limb muscle strength but also functional capacity, as assessed by the 6-minute walk test, and overall quality of life scores measured through the Pediatric Quality of Life Inventory. The findings suggest that incorporating Pilates into rehabilitation programs for pediatric burn survivors can contribute positively to physical and functional recovery, potentially improving their overall quality of life.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Riyadh
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Al-Kharj, Riyadh, Saudi Arabia, 11432
- Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children with lower limb (LL) healed burns. Age between 10 and 15 years. Six months post-injury. Mixed deep 2nd & 3rd degree burn. Total body surface area (TBSA) between 35-55 percent. Capability to walk securely without assistance.
Exclusion Criteria:
Lower limb joint range of motion limits. Mental illnesses. Significant behavioral or cognitive impairments. Incapacity to exercise. Metabolic diseases. Neuropathy. Visual or vestibular abnormalities. Medical instability.
Study Plan
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: traditional physical therapy programs
group that received traditional physical therapy programs (TPTP) alone
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The program included a variety of exercises such as range of motion exercises, aerobic exercises, resistance exercises, scar management, occupational therapy, and hand therapy.
Other Names:
|
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Experimental: Pilates group
received both traditional physical therapy programs and Pilates exercises.
|
The program included a variety of exercises such as range of motion exercises, aerobic exercises, resistance exercises, scar management, occupational therapy, and hand therapy.
Other Names:
participants underwent a 12-week intervention involving three Pilates sessions per week.
The Pilates exercises comprised warm-up activities, Pilates routines, and cool-down exercises.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength Assessment
Time Frame: at baseline
|
Assessed using a calibrated handheld dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA), participants performed three 5-second contractions for each muscle group.
The average score in newtons was calculated for each muscle group.
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at baseline
|
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Muscle Strength Assessment
Time Frame: after 12 weeks
|
Assessed using a calibrated handheld dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA), participants performed three 5-second contractions for each muscle group.
The average score in newtons was calculated for each muscle group.
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after 12 weeks
|
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6-minute walk test
Time Frame: at baseline
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Participants were timed and given six minutes to walk as far as they could along a straight course.
Running, jumping, or hopping were not allowed.
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at baseline
|
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6-minute walk test
Time Frame: after 12 weeks
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Participants were timed and given six minutes to walk as far as they could along a straight course.
Running, jumping, or hopping were not allowed.
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after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Quality of Life Inventory
Time Frame: at baseline
|
A self-report questionnaire assessing the health-related quality of life (HRQL) of children and adolescents.
It includes physical health, psychosocial health, and a total summary score.
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at baseline
|
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Pediatric Quality of Life Inventory
Time Frame: after 12 weeks
|
A self-report questionnaire assessing the health-related quality of life (HRQL) of children and adolescents.
It includes physical health, psychosocial health, and a total summary score.
|
after 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maged Basha, PhD, Qassim University
- Study Chair: Alshimaa Azab, PhD, Professor, Faculty of Physical Therapy, Cairo University
Publications and helpful links
General Publications
- Aibar-Almazan A, Martinez-Amat A, Cruz-Diaz D, Jesus de la Torre-Cruz M, Jimenez-Garcia JD, Zagalaz-Anula N, Redecillas-Peiro MT, Mendoza-Ladron de Guevara N, Hita-Contreras F. The Influence of Pilates Exercises on Body Composition, Muscle Strength, and Gait Speed in Community-Dwelling Older Women: A Randomized Controlled Trial. J Strength Cond Res. 2022 Aug 1;36(8):2298-2305. doi: 10.1519/JSC.0000000000003790. Epub 2020 Sep 25.
- Farrell RT, Gamelli RL, Sinacore J. Analysis of functional outcomes in patients discharged from an acute burn center. J Burn Care Res. 2006 Mar-Apr;27(2):189-94. doi: 10.1097/01.BCR.0000202615.59734.0E.
- Gojowy D, Kauke M, Ohmann T, Homann HH, Mannil L. Early and late-recorded predictors of health-related quality of life of burn patients on long-term follow-up. Burns. 2019 Sep;45(6):1300-1310. doi: 10.1016/j.burns.2019.03.016. Epub 2019 Jun 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHPT/023/014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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