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

NCT06141915 | Unknown

• 1 other identifier: P.T.REC/012/004579
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune System Disorder

Outcome Measures

Primary Outcomes (3)

• The immune markers

  total lymphocyte count (TLC) in 10\^9 cells/liter will be measured

  Three months

• Neutrophil to lymphocyte ratio (NLR)

  The immune markers

  Three months

• Platelet to lymphocyte ratio (PLR)

  The immune markers

  Three months

Secondary Outcomes (2)

• The Arabic version of post traumatic stress disorder PTSD Checklist Civilian Version

  Three months

• The quality of life (QoL)

  Three months

Study Arms (3)

Aerobic training and diet protocol group

EXPERIMENTAL

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

Other: Aerobic training

Aerobic training group

EXPERIMENTAL

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

Other: Aerobic training

Diet protocol group

ACTIVE COMPARATOR

30 patients will receive diet protocol for 12 weeks.

Other: diet protocol

Interventions

Aerobic training 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 and diet protocol group; Aerobic training group

diet protocol OTHER

diet protocol

Diet protocol group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical therapy, Cairo University

Giza, 3387722, Egypt

RECRUITING

MeSH Terms

Conditions

Immune System Diseases

Study Officials

• A G Elsayed, PHD

  Cairo University

  STUDY CHAIR

Central Study Contacts

A G Elsayed, PHD

CONTACT

01001475959; drayasa3ada@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy of surgery

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 21, 2023
• Study Start: November 14, 2023
• Primary Completion: February 19, 2024
• Study Completion: May 19, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)