Aerobic Training and Diet Protocol on Immune System in Burn Patients.

NCT ID: NCT06141915

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2024-05-19

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aerobic training and diet protocol group

30 patients received aerobic training and diet protocol for 12 weeks.

Group Type: EXPERIMENTAL

Aerobic training

Intervention Type: OTHER

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

Aerobic training group

30 patients will receive aerobic training for 30 minutes, three times per week for 12 weeks.

Group Type: EXPERIMENTAL

Aerobic training

Intervention Type: OTHER

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 group

30 patients will receive diet protocol for 12 weeks.

Group Type: ACTIVE_COMPARATOR

diet protocol

Intervention Type: OTHER

diet protocol

Interventions

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

Intervention Type: OTHER

diet protocol

diet protocol

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Gamal Fawzy El-Sayed

Lecturer of physical therapy of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

A G Elsayed, PHD

Role: STUDY_CHAIR

Cairo University

Locations

Faculty of Physical therapy, Cairo University

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

A G Elsayed, PHD

Role: CONTACT

drayasa3ada@yahoo.com

01001475959 ext. 02

Facility Contacts

Aya G Elsayed, PHD

Role: primary

drayasa3ada@yahoo.com

01001475959 ext. 02

Other Identifiers

P.T.REC/012/004579

Identifier Type: -

Identifier Source: org_study_id