Lower Limb Burn InjuryBurnNCT05803824
Qigong Exercise on Fatigue and Postural Imbalance in Lower Limb Burn Injury
A study testing exercise therapy program in people with Lower Limb Burn Injury, run by Cairo University at 1 site in Egypt.
Trial summary
90 patients who suffer from chronic fatigue syndrome and postural imbalance following Lower Limb Burn Injury. will be selected from outpatient clinic, faculty of physical therapy, Cairo university. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Lower Limb Burn Injury
- What is being tested?
- exercise therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2022to 1 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) age of the patient was ranged from 35 to 55 years; 2) weight range 60-85 kg, height 155- 170 cm; 3) total burned surface area (TBSA) was 20- 35% measured by the rule of nines; 4) the burn cause was thermal; 5) burn depth, partial-thickness burn injury; 6) at least 3 months after burn injuries; 7) and with low physical activity level
Who cannot join
- 1)inhalation injury; 2) leg amputation; 3) any limitation in LL range of motion; 4) auditory or visual problems; 5) congenital musculoskeletal deformities, especially in the foot; 6) psychiatric disorders; 7) paralysis; or 8) cardiac abnormalities or cardiac pacemakers.
- In order to apply the inclusion and exclusion criteria, all cases will be subjected to an interview and assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Baduanjin Qigong Exercise Program on Fatigue and Postural Imbalance Following Lower Limb Burn Injury
90 patients who suffer from chronic fatigue syndrome and postural imbalance following Lower Limb Burn Injury. will be selected from outpatient clinic, faculty of physical therapy, Cairo university. Patients will be assigned randomly into 3 groups of equal numbers, group A: (Study group A) will receive Baduanjin Qigong exercise plus selected exercise program. group B:(Study group B) will receive Baduanjin Qigong exercise, Group C (control group C) will receive selected exercise program .
Read the detailed description
Patients at group A: patients will receive Baduanjin Qigong exercise plus selected exercise. the subjects practiced Baduanjin exercise 3 times or above each week, 30- 60 minutes each time for 8 weeks. The subjects were required to complete the program in the fixed site and in a collective manner, with special personnel recording the attendance and providing guidance. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up to regulate the internal organs, (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft to regulate the functions of the spleen and stomach, (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body to relieve stress, (7) moving the hands down the back and legs and touching the feet to strengthen the kidneys, (8) thrusting the fists and making the eyes glare to enhance strength, and (9) raising and lowering the heels to cure diseases .
Selected Exercise Program: Patients will receive
- balance exercises 3 sessions a week for 8 weeks in the form of balance exercises and resisted exercises. Balance Exercises Each session of balance exercises is composed of three phases, including warm-up, balance training and cool down. The warm-up phase involved gentle stretching for calf, hamstring, quadriceps, iliopsoas muscles, as well as anterior, posterior and lateral step-ups for 5-10 minutes. The active phase was performed on a balance training mat of high-elasticity for 20 minutes. It included heel and toe raises, one-legged stance for each extremity, shifting weight anteriorly, posteriorly, laterally and diagonally. turning head to the right and then to the left with maintaining the feet together, walking in slow motion, step-ups, narrow walking, backward walking, sideward walking, stepping over obstacles, passing balls arranged on the training mat in a circle, and throwing and catching a ball on the training mat. The program ended with 5-10 minutes of cool down. During the cool-down phase, patients performed deep breathing exercises and static exercises for back extensor in a recumbent position.
- Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises for hip flexors and extensor, knee extensors and flexors, and ankle dorsiflexors. The exercises' intensity was progressed as the following; week one: 50-60% of three repetition maximum (3RM), from 2nd -6th weeks: 70- 75% of 3RM and for 7th -8th weeks: 80-85% 3RM for 4- 10 repetitions ,3 sessions a week for 8 weeks.
- Conditions
- Lower Limb Burn Injury
- Being tested
- exercise therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise therapy programOther
patients will receive Baduanjin Qigong exercise plus selected exercise. the subjects will recive Baduanjin exercise 3 times each week, 30- 60 minutes each time for 12 weeks.
The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up. (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft . (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body t. (7) moving the hands down the back and legs and touching the feet . (8) thrusting the fists and making the eyes glare . and (9) raising and lowering the heels .
Selected Exercise Program: Patients will receive
- balance exercises is composed of three phases, including warm-up, balance training and cool down.
- Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises
| Study group | Role | What they receive |
|---|---|---|
| group A: Baduanjin Qigong exercise plus selected exercise | Experimental | Baduanjin exercise 3 times each week, 30- 60 minutes each time for 12 weeks. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up. (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft . (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body t. (7) moving the hands down the back and legs and touching the feet . (8) thrusting the fists and making the eyes glare . and (9) raising and lowering the heels .
Puls Selected Exercise Program
* balance exercises is composed of three phases, including warm-up, balance training and cool down.
* Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises . Receives: Other: exercise therapy program |
| Patients at group B: patients will receive selected exercise program | Experimental | Selected Exercise Program: Patients will receive
* balance exercises is composed of three phases, including warm-up, balance training and cool down.
* Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises . Receives: Other: exercise therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Brief Fatigue Inventory (BFI)
The instrument is used to quickly assess the severity of fatigue experienced by cancer patients, as well as its impact on their ability to function over the previous 24 h.he BFI is a reliable and valid tool with a low respondent burden, suitable for measuring fatigue in burn patients during the first year of recovery.
Measured: 3months
b. The dynamic balance score
- The dynamic balance score that was measured by the Biodex Balance System (Biodex Medical System, Shirley, NY, USA). Biodex Balance System is a valid and reliable method to assess the dynamic balance. The system has a movable circular platform that permits about 20◦ tilt in 360◦ range so it is free to move about the anterior-posterior and mediallateral directions simultaneously
Measured: 3 months
Secondary outcomes (2)
b. The timed up and go (TUG) test
- The timed up and go (TUG) test is a basic mobility assessment tool that records the time taken (in seconds) to get up from a chair, walk 3-meter distance, come back and sit down again on the chair
Measured: 3 months
c. The Activities-specific Balance (ABC) scale
- The Activities-specific Balance (ABC) scale is a popular and subjective questionnaire to assess balance confidence and the risk of fall in people with balance problems.34 The ABC scale consisted of 16 items with a total score between 0% (not confident) to 100% (completely confident), where higher scores equate to higher balance confidence and vice versa. The Arabic version of the ABC scale is reliable and valid in the assessment of balance confidence.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start30 Dec 2022
- Primary completion30 Aug 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Burn InjuryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khadra Mohamed Ali, Cairo University
- Investigators
- Hassan, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803824
- Sponsor's protocol ID
- 2451981
- Acronym
- Burn
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after 6months we will share the study protocol and informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Baduanjin Qigong Exercise Program on Fatigue and Postural Imbalance Following Lower Limb Burn Injury
- ClinicalTrials.gov ID
- NCT05803824
- Acronym / sponsor ID
- Burn / 2451981
- Conditions
- Lower Limb Burn Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 7 Apr 2023 (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.
90 patients who suffer from chronic fatigue syndrome and postural imbalance following Lower Limb Burn Injury. will be selected from outpatient clinic, faculty of physical therapy, Cairo university. Patients will be assigned randomly into 3 groups of equal numbers, group A: (Study group A) will receive Baduanjin Qigong exercise plus selected exercise program. group B:(Study group B) will receive Baduanjin Qigong exercise, Group C (control group C) will receive selected exercise program .
Detailed description
Patients at group A: patients will receive Baduanjin Qigong exercise plus selected exercise. the subjects practiced Baduanjin exercise 3 times or above each week, 30- 60 minutes each time for 8 weeks. The subjects were required to complete the program in the fixed site and in a collective manner, with special personnel recording the attendance and providing guidance. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up to regulate the internal organs, (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft to regulate the functions of the spleen and stomach, (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body to relieve stress, (7) moving the hands down the back and legs and touching the feet to strengthen the kidneys, (8) thrusting the fists and making the eyes glare to enhance strength, and (9) raising and lowering the heels to cure diseases .
Selected Exercise Program: Patients will receive
- balance exercises 3 sessions a week for 8 weeks in the form of balance exercises and resisted exercises. Balance Exercises Each session of balance exercises is composed of three phases, including warm-up, balance training and cool down. The warm-up phase involved gentle stretching for calf, hamstring, quadriceps, iliopsoas muscles, as well as anterior, posterior and lateral step-ups for 5-10 minutes. The active phase was performed on a balance training mat of high-elasticity for 20 minutes. It included heel and toe raises, one-legged stance for each extremity, shifting weight anteriorly, posteriorly, laterally and diagonally. turning head to the right and then to the left with maintaining the feet together, walking in slow motion, step-ups, narrow walking, backward walking, sideward walking, stepping over obstacles, passing balls arranged on the training mat in a circle, and throwing and catching a ball on the training mat. The program ended with 5-10 minutes of cool down. During the cool-down phase, patients performed deep breathing exercises and static exercises for back extensor in a recumbent position.
- Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises for hip flexors and extensor, knee extensors and flexors, and ankle dorsiflexors. The exercises' intensity was progressed as the following; week one: 50-60% of three repetition maximum (3RM), from 2nd -6th weeks: 70- 75% of 3RM and for 7th -8th weeks: 80-85% 3RM for 4- 10 repetitions ,3 sessions a week for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A: Baduanjin Qigong exercise plus selected exercise | Experimental | Other: exercise therapy programBaduanjin exercise 3 times each week, 30- 60 minutes each time for 12 weeks. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up. (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft . (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body t. (7) moving the hands down the back and legs and touching the feet . (8) thrusting the fists and making the eyes glare . and (9) raising and lowering the heels . Puls Selected Exercise Program * balance exercises is composed of three phases, including warm-up, balance training and cool down. * Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises . |
| Patients at group B: patients will receive selected exercise program | Experimental | Other: exercise therapy programSelected Exercise Program: Patients will receive * balance exercises is composed of three phases, including warm-up, balance training and cool down. * Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises . |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) age of the patient was ranged from 35 to 55 years; 2) weight range 60-85 kg, height 155- 170 cm; 3) total burned surface area (TBSA) was 20- 35% measured by the rule of nines; 4) the burn cause was thermal; 5) burn depth, partial-thickness burn injury; 6) at least 3 months after burn injuries; 7) and with low physical activity level
Key exclusion criteria (2 listed)
- 1)inhalation injury; 2) leg amputation; 3) any limitation in LL range of motion; 4) auditory or visual problems; 5) congenital musculoskeletal deformities, especially in the foot; 6) psychiatric disorders; 7) paralysis; or 8) cardiac abnormalities or cardiac pacemakers.
- In order to apply the inclusion and exclusion criteria, all cases will be subjected to an interview and assessment.
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 |
|---|---|---|
| exercise therapy programpatients will receive Baduanjin Qigong exercise plus selected exercise. the subjects will recive Baduanjin exercise 3 times each week, 30- 60 minutes each time for 12 weeks. The whole set of Baduanjin exercise consists of 9 postures: (1) ready position, (2) holding the hands high with palms up. (3) posing like an archer shooting on left and right sides, (4) holding one arm aloft . (5) looking backwards to prevent sickness and strain, (6) swinging the head and lowering the body t. (7) moving the hands down the back and legs and touching the feet . (8) thrusting the fists and making the eyes glare . and (9) raising and lowering the heels . Selected Exercise Program: Patients will receive * balance exercises is composed of three phases, including warm-up, balance training and cool down. * Resisted Exercises were given according to the standardized Oxford technique of progressive resistance exercises | Other | Patients at group B: patients will receive selected exercise program, group A: Baduanjin Qigong exercise plus selected exercise |
Primary outcome
The Brief Fatigue Inventory (BFI)
Time frame: 3months
The instrument is used to quickly assess the severity of fatigue experienced by cancer patients, as well as its impact on their ability to function over the previous 24 h.he BFI is a reliable and valid tool with a low respondent burden, suitable for measuring fatigue in burn patients during the first year of recovery.
b. The dynamic balance score
Time frame: 3 months
c. The dynamic balance score that was measured by the Biodex Balance System (Biodex Medical System, Shirley, NY, USA). Biodex Balance System is a valid and reliable method to assess the dynamic balance. The system has a movable circular platform that permits about 20◦ tilt in 360◦ range so it is free to move about the anterior-posterior and mediallateral directions simultaneously
2 secondary outcomes
b. The timed up and go (TUG) test
Time frame: 3 months
c. The Activities-specific Balance (ABC) scale
Time frame: 3months
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 19 Nov 2024.
- Individual participant dataSharing planned: Yes. after 6months we will share the study protocol and informed consent.
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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.
Hassan principal investigator
Cairo 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 exercise therapy program in people with Lower Limb Burn Injury, run by Cairo University at 1 site in Egypt.
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 2 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 19 Nov 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 Egypt. 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?
The Brief Fatigue Inventory (BFI) (time frame: 3months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2024.