Aerobic Exercises on Persisted Post Burn Anemia

NCT06849479 | Active Not Recruiting

• 1 other identifier: P.T.Rec/012/005217
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Fourty patients who have total body surface area ranged from 20% to 35% of burn, anemic and 8th to 16th week post burn will participate in this study, the patients will be randomly divided into two equal groups (20 patients for each group): Group A (Experimental Group) (Aerobic exercise and medical treatment): Group B ( Control Group) (Medical treatment group):

Conditions

Burns

Outcome Measures

Primary Outcomes (3)

• Red blood cells

  It will be drawn by the doctor and a specialist nurse. Red blood cell (RBC) count measures the number of red blood cells in your blood. The unit of measurements is cell per microliter. Normal RBC ranges are: Male: 4.7 to 6.1 million cells per microliter (cells/mcL) Female: 4.2 to 5.4 million cells/mcL.

  pre intervention and re assessed after 6 weeks of treatment

• Hemoglobin

  It will be drawn by the doctor and a specialist nurse. The unit of measurement is grams/deciliter. Normal range for men is , 13.2 to 16.6 grams per deciliter. Normal range for women is, 11.6 to 15 grams per deciliter.

  pre intervention and re assessed after 6 weeks of treatment

• Hematocrit

  It will be drawn by the doctor and a specialist nurse. The hematocrit is the percentage of packed RBCs in the whole blood. The hematocrit has the implied units of L/L, although it is usually reported as a percent. Normal range for Males: 41% to 50%. Normal range for Females: 36% to 44%.

  pre intervention and re assessed after 6 weeks of treatment

Study Arms (2)

Group A

EXPERIMENTAL

This group includes 20 patients who had severe burn with total body surface area ranged from 20% to 35%. These patients will receive aerobic exercises in addition to medical treatment of anemia.

Procedure: Aerobic exercise and medical treatment; Dietary Supplement: Medical treatment group

Group B

PLACEBO COMPARATOR

This group includes 20 patients who had severe burn with total body surface area ranged from 20 to 35%. These patients will receive a medical treatment of anemia.

Dietary Supplement: Medical treatment group

Interventions

Aerobic exercise and medical treatment PROCEDURE

Aerobic exercise training was done for 30 minutes, day after day (3 sessions weekly) for 6 weeks. Each session started by warming up phase that was walking on treadmill for 5 minutes at 20% of target heart rate. Active phase after warming up was walking on treadmill for 20 min at 50-70 % of target heart rate. And cooling down phase after the active phase of exercise was walking on treadmill for 5 minutes at 20 % of the target heart rate

Group A

Medical treatment group DIETARY_SUPPLEMENT

patient received supplement in the form of one capsule daily, that contain iron supplement (10 mg) and multi vitamins (B1=0.6 mg;, B2=0.6 mg; B6=0.6 mg; B12= 1.2 mc and C=30 mg) as well as essential trace elements (Zinc=5 mg; Copper=0.44 mg; Folic acid=200 mc and Biotin=12 mc

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject selection will be according to the following criteria:
• Ages of patients will be ranged from 20 to 35 years.
• All patients underwent severe burn with TBSA ranged from 20% to 35%.
• th to 16th week post burn.
• All patients will be referred with persisted anemia by a surgeon before starting the study procedure.
• All patients will enter the study having their informed consent

You may not qualify if:

• The potential participants will be excluded if they meet one of the following criteria: 16
• Patients with persisted pre burn anemia associated with systematic chronic disease such as coronary artery disease or chronic kidney disease.
• Patients with pre burn persisted anemia associated with autoimmune disease such as Rheumatoid arthritis, Systemic lupus erythematosus ,Vasculitis, Sarcoidosis, Inflammatory bowel disease (IBD).
• Unevaluated cardiac arrhythmia, Chronic bronchitis, poorly controlled type 1 diabetes, Extreme morbid obesity, Extreme underweight body mass index less than 12, Poorly controlled hypertension, Poorly controlled seizure disorder, Poorly controlled hyperthyroidism, Orthopedic limitation as fracture, .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Burns

Interventions

Exercise

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 27, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

EG (1)