BurnsNCT06237361
Pilates Benefits in Pediatric Burn Survivors
A study testing Pilates exercises and traditional physical therapy program in people with Burns and Pilates Exercise, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
This study investigated the effects of Pilates exercises on lower limb muscle strength, functional capacity, and quality of life in children with burn injuries. In a twelve-week randomized clinical trial involving 60 children, those who received Pilates exercises in addition to traditional physical therapy showed… Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Burns, Pilates Exercise, Pediatric Burn
- What is being tested?
- Pilates exercises and traditional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Jun 2022to 15 Dec 2023
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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: Muscle Strength, Functional Capacity and Quality of Life Responses to Pilates Exercises in Children With Burn Injuries
This study investigated the effects of Pilates exercises on lower limb muscle strength, functional capacity, and quality of life in children with burn injuries. In a twelve-week randomized clinical trial involving 60 children, those who received Pilates exercises in addition to traditional physical therapy showed significant improvements in muscle strength, functional capacity, and overall quality of life compared to those who received traditional therapy alone. The findings suggest that incorporating Pilates exercises into rehabilitation programs may enhance outcomes for children recovering from burn injuries.
Read the 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.
- Conditions
- Burns, Pilates Exercise, Pediatric Burn
- Being tested
- Pilates exercises, traditional physical therapy program
- Medical subject headings
- Burns
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
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.
traditional physical therapy programOther
Also called Exercise
The program included a variety of exercises such as range of motion exercises, aerobic exercises, resistance exercises, scar management, occupational therapy, and hand therapy.
| Study group | Role | What they receive |
|---|---|---|
| traditional physical therapy programs | Experimental | group that received traditional physical therapy programs (TPTP) alone Receives: Other: traditional physical therapy program |
| Pilates group | Experimental | received both traditional physical therapy programs and Pilates exercises. Receives: Other: Pilates exercises; Other: traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength Assessment
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.
Measured: at baseline
Muscle Strength Assessment
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.
Measured: after 12 weeks
6-minute walk test
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.
Measured: at baseline
6-minute walk test
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.
Measured: after 12 weeks
Secondary outcomes (2)
Pediatric Quality of Life Inventory
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.
Measured: at baseline
Pediatric Quality of Life Inventory
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.
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 posted1 Feb 2024
- Study start10 Jun 2022
- Primary completion22 Oct 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University, Cairo University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- Alshimaa Azab, PhD, Study chair, Professor, Faculty of Physical Therapy, Cairo UniversityMaged Basha, PhD, Study director, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237361
- Sponsor's protocol ID
- RHPT/023/014
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 1 Feb 2024
- 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
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.
PubMed 32991508Farrell 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.
PubMed 16566563Gojowy 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.
PubMed 31176508Azab AR, Basalem N, Alghadier M, Khanam H, George J, Aloraini SM, Alsultan F, Basha MA, S Waked I, Kamel FH. Muscle Strength, Functional Capacity, and Quality of Life Responses to Pilates Exercises in Children with Burn Injuries: A Single-Blinded Randomized Clinical Trial. Iran J Med Sci. 2025 Nov 1;50(11):743-753. doi: 10.30476/ijms.2025.104947.3852. eCollection 2025 Nov.
PubMed 41262321
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Strength, Functional Capacity and Quality of Life Responses to Pilates Exercises in Children With Burn Injuries
- ClinicalTrials.gov ID
- NCT06237361
- Acronym / sponsor ID
- RHPT/023/014
- Conditions
- Burns, Pilates Exercise, Pediatric Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University, Cairo University
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 22 Oct 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 1 Feb 2024 (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.
This study investigated the effects of Pilates exercises on lower limb muscle strength, functional capacity, and quality of life in children with burn injuries. In a twelve-week randomized clinical trial involving 60 children, those who received Pilates exercises in addition to traditional physical therapy showed significant improvements in muscle strength, functional capacity, and overall quality of life compared to those who received traditional therapy alone. The findings suggest that incorporating Pilates exercises into rehabilitation programs may enhance outcomes for children recovering from burn injuries.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional physical therapy programs | Experimental | Other: traditional physical therapy programgroup that received traditional physical therapy programs (TPTP) alone |
| Pilates group | Experimental | Other: Pilates exercises, Other: traditional physical therapy programreceived both traditional physical therapy programs and Pilates exercises. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 bandparticipants 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 | Pilates group |
| traditional physical therapy programAlso: ExerciseThe program included a variety of exercises such as range of motion exercises, aerobic exercises, resistance exercises, scar management, occupational therapy, and hand therapy. | Other | Pilates group, traditional physical therapy programs |
Primary outcome
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.
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.
6-minute walk test
Time frame: at baseline
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.
6-minute walk test
Time frame: after 12 weeks
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.
2 secondary outcomes
Pediatric Quality of Life Inventory
Time frame: at baseline
Pediatric Quality of Life Inventory
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 1 Feb 2024.
- Background: PubMed 32991508Aibar-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.
- Results publication: PubMed 16566563Farrell 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.
- Results publication: PubMed 31176508Gojowy 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.
- Derived from this study: PubMed 41262321Azab AR, Basalem N, Alghadier M, Khanam H, George J, Aloraini SM, Alsultan F, Basha MA, S Waked I, Kamel FH. Muscle Strength, Functional Capacity, and Quality of Life Responses to Pilates Exercises in Children with Burn Injuries: A Single-Blinded Randomized Clinical Trial. Iran J Med Sci. 2025 Nov 1;50(11):743-753. doi: 10.30476/ijms.2025.104947.3852. eCollection 2025 Nov.
- 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
Professor, Faculty of Physical Therapy, 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 traditional physical therapy program in people with Burns and Pilates Exercise, 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 1 inclusion and 1 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 1 Feb 2024. 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?
Muscle Strength 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 NCT06237361, which also lists 4 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 1 Feb 2024.