Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06141915
Other study ID # P.T.REC/012/004579
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 14, 2023
Est. completion date May 19, 2024

Study information

Verified date November 2023
Source Cairo University
Contact A G Elsayed, PHD
Phone 01001475959
Email drayasa3ada@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date May 19, 2024
Est. primary completion date February 19, 2024
Accepts healthy volunteers No
Gender All
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Inhalation injury. - Leg amputation. - Any limitation in LL range of motion. - Auditory or visual problems. - Congenital musculoskeletal deformities, especially in the foot. - Psychiatric disorders. - Paralysis. - Cardiac abnormalities or cardiac pacemakers. - Patients who participated in any rehabilitation program before the study that may affect our results.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic training
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 protocol
diet protocol

Locations

Country Name City State
Egypt Faculty of Physical therapy, Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The immune markers total lymphocyte count (TLC) in 10^9 cells/liter will be measured Three months
Primary Neutrophil to lymphocyte ratio (NLR) The immune markers Three months
Primary Platelet to lymphocyte ratio (PLR) The immune markers Three months
Secondary 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 Three months
Secondary 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 Three months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04430972 - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Not yet recruiting NCT04830046 - Covid-19 Vaccine Responsiveness in MM and Waldenstrom
Recruiting NCT04928963 - Fighting Immunosenescence and Promoting Immunity by a Fasting-mimicking Diet Elderly. Phase 1/Phase 2
Recruiting NCT05507242 - Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD Phase 2
Completed NCT03385850 - The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis N/A
Completed NCT03744676 - A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007) Phase 2
Recruiting NCT03908736 - Thinking Zinc: a Study of Zinc Supplements on the Navajo Nation N/A
Completed NCT04386395 - Immune Changes in Severe COVID-19 Pulmonary Infections
Active, not recruiting NCT06060509 - Study on the Effects of Wheat and Corn Germ Blend Oil on Antioxidation and Immune Regulation of Dyslipidemia Population N/A
Recruiting NCT04444609 - PROSAIC-19 - Prospective Longitudinal Assessment in a COVID-19 Infected Cohort
Terminated NCT04294459 - Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation Phase 1/Phase 2
Recruiting NCT06314451 - Cross-condition Validation of the Steroid PRO
Completed NCT05000307 - Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection N/A
Active, not recruiting NCT06107348 - COVID-19 Post-Vaccination Observation
Recruiting NCT05139706 - Montreal Immune-Related Adverse Events (MIRAE) Study
Withdrawn NCT05219890 - Transcriptomics of Mononuclear Cells and Inflammatory Status of Obese Patients Treated With Omega-3 Fatty Acids N/A
Completed NCT03357939 - Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects Phase 1
Recruiting NCT05002023 - PRINCE Study - Cohort Study of Healthy Pregnant Women Followed by the Assessment of Children´s Health and Immunity
Recruiting NCT05266664 - Preterm Immune System Development and Response to Immunization
Active, not recruiting NCT04802044 - COVID-19, Aging, and Cardiometabolic Risk Factors Study