Immune System DisorderNCT06141915
Aerobic Training and Diet Protocol on Immune System in Burn Patients.
A study testing Aerobic training and diet protocol in people with Immune System Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
Aerobic exercises can produce immediate and short-term improvements in the immune response of leukocytes, T-lymphocytes, lymphocyte subpopulations, interleukins, and immunoglobulins. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Immune System Disorder
- What is being tested?
- Aerobic training and diet protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Nov 2023to 19 May 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients from both genders.
- The age ranges from 25 to 40 years.
- Weight range 60-85 kg, height 155- 170 cm.
- Total burned surface area (TBSA) was 20- 40% measured by the rule of nines.
- Thermal burn.
- Burn depth, partial-thickness burn injury.
- Patient will participate in the study one month after discharge.
Who cannot join
- Inhalation injury.
- Leg amputation.
- Any limitation in LL range of motion.
- Auditory or visual problems.
- Congenital musculoskeletal deformities, especially in the foot.
- Psychiatric disorders.
Show all 9Show fewer
- Paralysis.
- Cardiac abnormalities or cardiac pacemakers.
- Patients who participated in any rehabilitation program before the study that may affect our results.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical therapy, Cairo University
Giza, 3387722
Aya G Elsayed, PHD, 01001475959 ext. 02, drayasa3ada@yahoo.com
About this study
Official title: Aerobic Training Combined With Diet Protocol on Immune System in Burn Patients.
Aerobic exercises can produce immediate and short-term improvements in the immune response of leukocytes, T-lymphocytes, lymphocyte subpopulations, interleukins, and immunoglobulins. Even only a single session of aerobic exercises produces improvements in the utmost immune markers, such as T-lymphocytes, leukocytes, and immunoglobulins.
Also, burned patients suffer from post-traumatic stress and stress can cause this alteration through its effect on increasing the amounts of serum corticosteroid and catecholamine hormones, thus a decrease in the immunity response might occur. Increasing the aerobic capacity can significantly improve the mood. This might be attributed to the effect of aerobic exercises on decreasing stress hormones, like corticosteroids and catecholamines hormones.
Read more
The altered metabolism post major burn also affects the immune system in burn patients and the aerobic training enhances the metabolism, body composition and the lean mass and so, enhances the immune system.
One of the most important factors for a good and effective immune system is the balanced diet especially diet rich in vitamin D, fibers, and multiple nuts and seeds such as almond, walnut, pistachio, sunflower seeds, flax seeds and sesame seed that have an crucial role in improving the immune system either acting on it directly or indirectly by enhancing the general heath of the body and the patients mood.
Read the detailed description
Group A (Aerobic training and diet protocol group): patients will be engaged in aerobic training using treadmill three times per week, for 12 weeks. The exercise intensity will be 50-70% of each patient's maximum heart rate. Each exercise session will consist of three phases; five-minutes warming up phase in form of stretching exercises and walking on the treadmill at the slowest speed, 20-minutes conditioning phase in form of walking on the treadmill at 50% of participants' maximum heart rate in the first two weeks then progressed gradually to reach the 70% of maximum heart rate by the 12th weeks", and five-minutes cool down phase that will be constant as warming up phase. During the training, the patient's blood pressure, heart rate, and breathing pattern will be frequently monitored . Also, the will be asked to follow a diet protocol designed by the nutrition specialist that rich in in vitamin D, fibers, and multiple nuts and seeds such as almond, walnut, pistachio, sunflower seeds, flax seeds and sesame seed to improve immune system for 12 weeks.
Group B (Aerobic training group): Patients will practice the aerobic training only like that of group A for 30 minutes, three sessions per week for 12 weeks.
Group C (Diet protocol group): Patients will only follow the same diet protocol that will be prescribed to group A for 12 weeks All patients in all groups will receive the same medical and traditional physical therapy in form of proper positioning and splinting and stretching, RoM, graduated strengthening exercises.
- Conditions
- Immune System Disorder
- Being tested
- Aerobic training, diet protocol
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
patients will be engaged in aerobic training using treadmill three times per week, for 12 weeks. The exercise intensity will be 50-70% of each patient's maximum heart rate. Each exercise session will consist of three phases; five-minutes warming up phase in form of stretching exercises and walking on the treadmill at the slowest speed, 20-minutes conditioning phase in form of walking on the treadmill at 50% of participants' maximum heart rate in the first two weeks then progressed gradually to reach the 70% of maximum heart rate by the 12th weeks", and five-minutes cool down phase that will be constant as warming up phase. During the training, the patient's blood pressure, heart rate, and breathing pattern will be frequently monitored
diet protocolOther
diet protocol
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training and diet protocol group | Experimental | 30 patients received aerobic training and diet protocol for 12 weeks. Receives: Other: Aerobic training |
| Aerobic training group | Experimental | 30 patients will receive aerobic training for 30 minutes, three times per week for 12 weeks. Receives: Other: Aerobic training |
| Diet protocol group | Active comparator | 30 patients will receive diet protocol for 12 weeks. Receives: Other: diet protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The immune markers
total lymphocyte count (TLC) in 10^9 cells/liter will be measured
Measured: Three months
Neutrophil to lymphocyte ratio (NLR)
The immune markers
Measured: Three months
Platelet to lymphocyte ratio (PLR)
The immune markers
Measured: Three months
Secondary outcomes (2)
The Arabic version of post traumatic stress disorder PTSD Checklist Civilian Version
It is a 17-item self-report scale that measures PTSD symptom severity
Measured: Three months
The quality of life (QoL)
Burn Specific Health Scale-Brief (BSHS-B) questionnaire will be used for the assessment of general, physical, mental, and social health aspects of the burn survivors
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start14 Nov 2023
- Primary completion19 Feb 2024 (estimated)
- Study completion19 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System DisorderStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Fawzy El-Sayed, Cairo University
- Investigators
- A G Elsayed, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141915
- Sponsor's protocol ID
- P.T.REC/012/004579
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Training Combined With Diet Protocol on Immune System in Burn Patients.
- ClinicalTrials.gov ID
- NCT06141915
- Acronym / sponsor ID
- P.T.REC/012/004579
- Conditions
- Immune System Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 19 Feb 2024 (estimated)
- Study completion
- 19 May 2024 (estimated)
- First posted
- 21 Nov 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.
Aerobic exercises can produce immediate and short-term improvements in the immune response of leukocytes, T-lymphocytes, lymphocyte subpopulations, interleukins, and immunoglobulins. Even only a single session of aerobic exercises produces improvements in the utmost immune markers, such as T-lymphocytes, leukocytes, and immunoglobulins.
Also, burned patients suffer from post-traumatic stress and stress can cause this alteration through its effect on increasing the amounts of serum corticosteroid and catecholamine hormones, thus a decrease in the immunity response might occur. Increasing the aerobic capacity can significantly improve the mood. This might be attributed to the effect of aerobic exercises on decreasing stress hormones, like corticosteroids and catecholamines hormones.
The altered metabolism post major burn also affects the immune system in burn patients and the aerobic training enhances the metabolism, body composition and the lean mass and so, enhances the immune system.
One of the most important factors for a good and effective immune system is the balanced diet especially diet rich in vitamin D, fibers, and multiple nuts and seeds such as almond, walnut, pistachio, sunflower seeds, flax seeds and sesame seed that have an crucial role in improving the immune system either acting on it directly or indirectly by enhancing the general heath of the body and the patients mood.
Detailed description
Group A (Aerobic training and diet protocol group): patients will be engaged in aerobic training using treadmill three times per week, for 12 weeks. The exercise intensity will be 50-70% of each patient's maximum heart rate. Each exercise session will consist of three phases; five-minutes warming up phase in form of stretching exercises and walking on the treadmill at the slowest speed, 20-minutes conditioning phase in form of walking on the treadmill at 50% of participants' maximum heart rate in the first two weeks then progressed gradually to reach the 70% of maximum heart rate by the 12th weeks", and five-minutes cool down phase that will be constant as warming up phase. During the training, the patient's blood pressure, heart rate, and breathing pattern will be frequently monitored . Also, the will be asked to follow a diet protocol designed by the nutrition specialist that rich in in vitamin D, fibers, and multiple nuts and seeds such as almond, walnut, pistachio, sunflower seeds, flax seeds and sesame seed to improve immune system for 12 weeks.
Group B (Aerobic training group): Patients will practice the aerobic training only like that of group A for 30 minutes, three sessions per week for 12 weeks.
Group C (Diet protocol group): Patients will only follow the same diet protocol that will be prescribed to group A for 12 weeks All patients in all groups will receive the same medical and traditional physical therapy in form of proper positioning and splinting and stretching, RoM, graduated strengthening exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic training and diet protocol group | Experimental | Other: Aerobic training30 patients received aerobic training and diet protocol for 12 weeks. |
| Aerobic training group | Experimental | Other: Aerobic training30 patients will receive aerobic training for 30 minutes, three times per week for 12 weeks. |
| Diet protocol group | Active comparator | Other: diet protocol30 patients will receive diet protocol for 12 weeks. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients from both genders.
- The age ranges from 25 to 40 years.
- Weight range 60-85 kg, height 155- 170 cm.
- Total burned surface area (TBSA) was 20- 40% measured by the rule of nines.
- Thermal burn.
Key exclusion criteria (9 listed)
- Inhalation injury.
- Leg amputation.
- Any limitation in LL range of motion.
- Auditory or visual problems.
- Congenital musculoskeletal deformities, especially in the foot.
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 |
|---|---|---|
| Aerobic trainingpatients will be engaged in aerobic training using treadmill three times per week, for 12 weeks. The exercise intensity will be 50-70% of each patient's maximum heart rate. Each exercise session will consist of three phases; five-minutes warming up phase in form of stretching exercises and walking on the treadmill at the slowest speed, 20-minutes conditioning phase in form of walking on the treadmill at 50% of participants' maximum heart rate in the first two weeks then progressed gradually to reach the 70% of maximum heart rate by the 12th weeks", and five-minutes cool down phase that will be constant as warming up phase. During the training, the patient's blood pressure, heart rate, and breathing pattern will be frequently monitored | Other | Aerobic training and diet protocol group, Aerobic training group |
| diet protocoldiet protocol | Other | Diet protocol group |
Primary outcome
The immune markers
Time frame: Three months
total lymphocyte count (TLC) in 10^9 cells/liter will be measured
Neutrophil to lymphocyte ratio (NLR)
Time frame: Three months
The immune markers
Platelet to lymphocyte ratio (PLR)
Time frame: Three months
The immune markers
2 secondary outcomes
The Arabic version of post traumatic stress disorder PTSD Checklist Civilian Version
Time frame: Three months
The quality of life (QoL)
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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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.
A G Elsayed, 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 Aerobic training and diet protocol in people with Immune System Disorder, 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 7 inclusion and 9 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 21 Nov 2023. 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 A G Elsayed, PHD (01001475959 ext. 02, drayasa3ada@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The immune markers (time frame: Three months). The study lists 3 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 21 Nov 2023.