BurnsNCT05276843
Efficacy of Selected Exercises on Bone Mineral Density in Post-burn Patients
A study testing Qigong exercise program in people with Burns, run by Eman Mohamed othman at 1 site in Egypt.
Trial summary
PURPOSE: to assess the efficacy of Qigong exercise on bone mineral density in post-burned patient. BACKGROUND: During severe burns, more than 7% of the vertebral bone mineral density (BMD) is lost within 3-6 weeks of the injury and about 3% of the total body bone content is lost during the first 6 months after the… Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Burns
- What is being tested?
- Qigong exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to Apr 2022
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients were 25-50 years old
- had thermal burn injuries of 2nd-3rd degree extended from the lower area of trunk to the lower extremities.
- the affected total body surface area of 30-45%.
- In the early burn stage (30-45 days in burn units), all patients were subjected to a unified physical therapy program consisted of positioning, range of motion, and gentle stretching exercises.
Who cannot join
- any history of endocrine, metabolic or other systemic diseases
- prior or ongoing supplementation with calcium
- previous or current bone-specific drugs or diseases affecting bone metabolism
- smoking
- any neurogenic disorder impairing sensory or motor function
- use of drugs known to affect the central nervous system or equilibrium
Show all 18Show fewer
- previous brain injury or any disease affecting balance
- history of epilepsy
- previous or habitual high-intensity exercise
- lower extremity arthralgia
- lower extremity implant
- recent surgeries for heart or spine
- cancer
- hernia
- acute thrombosis
- kidney or bladder stones
- diabetes
- serious cardiovascular or cerebrovascular disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy
Giza, 11432
gehan el miniawi, PhD, 002020237617691, Info@pt.cu.edu.eg
About this study
PURPOSE: to assess the efficacy of Qigong exercise on bone mineral density in post-burned patient.
BACKGROUND: During severe burns, more than 7% of the vertebral bone mineral density (BMD) is lost within 3-6 weeks of the injury and about 3% of the total body bone content is lost during the first 6 months after the injury.
Read more
Qigong exercise has been shown to be effective at attenuating declines in BMD and improving both balance performance and balance confidence in healthy middle-aged and older adults.
There are lack in knowledge and information in published studies about the efficacy of Qigong exercise on bone mineral density in post-burned patient.
So, this study will be designed to provide a guideline about the efficacy of Qigong exercise on bone mineral density in post-burned patient.
HYPOTHESES:
It will be hypothesized that:
It was hypothesized that Qigong exercise has no or limited effect in bone mineral density in post-burned patient.
RESEARCH QUESTION: Does Qigong exercise an effect on bone mineral density in post-burned patient?
Read the detailed description
- Measurement procedure: Bone density measurement was conducted before the first session and after two months of treatment. The test worked by measuring a specific bone or bones, usually the spine, hip and wrist. The density of these bones was then compared with an average index based on age, sex and size. The resulting comparison is used to determine risk for fractures and the stage of osteoporosis in an individual. Average bone mineral density = BMC/W (g/cm²).
- BMC = bone mineral content = g/cm.
- W = width at the scanned line. Data was graded according to Z score. Z-score: The Z-score is the comparison to the age matched normal subject. This is the number of standard deviations a patient's bone mineral density (BMD) differs from the average BMD of their age, sex and ethnicity. This value is used in premenopausal women, men under the age of 50, and in children. It is most useful when the score is less than 2 standard deviations below this normal. In this setting, it is helpful to scrutinize for coexisting illnesses that may contribute to osteoporosis such as glucocorticoid therapy, hyperparathyroidism or alcoholism. Z-score minus 1.5 and lower is considered below expected range of age, while Z-score above minus 1.5 is considered within expected range of age
- Treatment procedures:
In this study the treatment protocol was presented in the form of an exercise program lasted for 50 minutes, twice weekly for 12 weeks postburn and consisted of weight bearing, strengthening and aerobic exercises and achieved under the following phases:
- Warming up phase: The main aim of this phase was to get the muscles warm and loose for strength training. The subject has to train for ten minutes on a stationary bicycle at a mild velocity before the beginning of each exercise session. Bicycling helps direct needed blood flow to the muscles and prepares the body for exercise. Warming up is important for preventing injury as well as gaining maximal benefit from the exercise, because loose and warm muscles respond better to the challenge of the program.
- Exercise phase:
Qigong is a low-impact, weight-bearing exercise characterized by gentle movements designed to dissipate force throughout the body while the subject changes poses, with well-coordinated sequences of both isometric and isotonic segmental movements in the trunk and 4 extremities. This style emphasizes slow and smooth movement involving major muscle groups, at a constant speed while practicing. The sway of its moment is usually centered, which makes it more safe for the elderly to practice.
- Conditions
- Burns
- Being tested
- Qigong exercise program
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong exercise programCombination product
Qigong is a low-impact, weight-bearing exercise characterized by gentle movements designed to dissipate force throughout the body while the subject changes poses, with well-coordinated sequences of both isometric and isotonic segmental movements in the trunk and 4 extremities.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | receive Qigong exercise in addition to traditional physical therapy program Receives: Combination Product: Qigong exercise program |
| group B | No intervention | receive traditional physical therapy program only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density measurement
The test worked by measuring a specific bone or bones, usually the spine, hip and wrist. The density of these bones was then compared with an average index based on age, sex and size. The resulting comparison is used to determine risk for fractures and the stage of osteoporosis in an individual.
Measured: change in bone mineral density calculated at 8 weeks post treatment minus baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Mar 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman Mohamed othman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Mohamed othman, Cairo University
- Investigators
- eman othman, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276843
- Sponsor's protocol ID
- 00000000
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Selected Exercises on Bone Mineral Density in Post-burn Patients
- ClinicalTrials.gov ID
- NCT05276843
- Acronym / sponsor ID
- 00000000
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eman Mohamed othmanUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 11 Mar 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.
PURPOSE: to assess the efficacy of Qigong exercise on bone mineral density in post-burned patient.
BACKGROUND: During severe burns, more than 7% of the vertebral bone mineral density (BMD) is lost within 3-6 weeks of the injury and about 3% of the total body bone content is lost during the first 6 months after the injury.
Qigong exercise has been shown to be effective at attenuating declines in BMD and improving both balance performance and balance confidence in healthy middle-aged and older adults.
There are lack in knowledge and information in published studies about the efficacy of Qigong exercise on bone mineral density in post-burned patient.
So, this study will be designed to provide a guideline about the efficacy of Qigong exercise on bone mineral density in post-burned patient.
HYPOTHESES:
It will be hypothesized that:
It was hypothesized that Qigong exercise has no or limited effect in bone mineral density in post-burned patient.
RESEARCH QUESTION: Does Qigong exercise an effect on bone mineral density in post-burned patient?
Detailed description
- Measurement procedure: Bone density measurement was conducted before the first session and after two months of treatment. The test worked by measuring a specific bone or bones, usually the spine, hip and wrist. The density of these bones was then compared with an average index based on age, sex and size. The resulting comparison is used to determine risk for fractures and the stage of osteoporosis in an individual. Average bone mineral density = BMC/W (g/cm²).
- BMC = bone mineral content = g/cm.
- W = width at the scanned line. Data was graded according to Z score. Z-score: The Z-score is the comparison to the age matched normal subject. This is the number of standard deviations a patient's bone mineral density (BMD) differs from the average BMD of their age, sex and ethnicity. This value is used in premenopausal women, men under the age of 50, and in children. It is most useful when the score is less than 2 standard deviations below this normal. In this setting, it is helpful to scrutinize for coexisting illnesses that may contribute to osteoporosis such as glucocorticoid therapy, hyperparathyroidism or alcoholism. Z-score minus 1.5 and lower is considered below expected range of age, while Z-score above minus 1.5 is considered within expected range of age
- Treatment procedures:
In this study the treatment protocol was presented in the form of an exercise program lasted for 50 minutes, twice weekly for 12 weeks postburn and consisted of weight bearing, strengthening and aerobic exercises and achieved under the following phases:
- Warming up phase: The main aim of this phase was to get the muscles warm and loose for strength training. The subject has to train for ten minutes on a stationary bicycle at a mild velocity before the beginning of each exercise session. Bicycling helps direct needed blood flow to the muscles and prepares the body for exercise. Warming up is important for preventing injury as well as gaining maximal benefit from the exercise, because loose and warm muscles respond better to the challenge of the program.
- Exercise phase:
Qigong is a low-impact, weight-bearing exercise characterized by gentle movements designed to dissipate force throughout the body while the subject changes poses, with well-coordinated sequences of both isometric and isotonic segmental movements in the trunk and 4 extremities. This style emphasizes slow and smooth movement involving major muscle groups, at a constant speed while practicing. The sway of its moment is usually centered, which makes it more safe for the elderly to practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Combination Product: Qigong exercise programreceive Qigong exercise in addition to traditional physical therapy program |
| group B | No intervention | –receive traditional physical therapy program only |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients were 25-50 years old
- had thermal burn injuries of 2nd-3rd degree extended from the lower area of trunk to the lower extremities.
- the affected total body surface area of 30-45%.
- In the early burn stage (30-45 days in burn units), all patients were subjected to a unified physical therapy program consisted of positioning, range of motion, and gentle stretching exercises.
Key exclusion criteria (18 listed)
- any history of endocrine, metabolic or other systemic diseases
- prior or ongoing supplementation with calcium
- previous or current bone-specific drugs or diseases affecting bone metabolism
- smoking
- any neurogenic disorder impairing sensory or motor function
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 |
|---|---|---|
| Qigong exercise programQigong is a low-impact, weight-bearing exercise characterized by gentle movements designed to dissipate force throughout the body while the subject changes poses, with well-coordinated sequences of both isometric and isotonic segmental movements in the trunk and 4 extremities. | Combination product | group A |
Primary outcome
Bone density measurement
Time frame: change in bone mineral density calculated at 8 weeks post treatment minus baseline.
The test worked by measuring a specific bone or bones, usually the spine, hip and wrist. The density of these bones was then compared with an average index based on age, sex and size. The resulting comparison is used to determine risk for fractures and the stage of osteoporosis in an individual.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication.
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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.
eman othman, PhD study chair
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 Qigong exercise program in people with Burns, run by Eman Mohamed othman 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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 11 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eman othman, PhD (0020201120572128, dr.emanothman@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density measurement (time frame: change in bone mineral density calculated at 8 weeks post treatment minus baseline.). 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 11 Mar 2022.