Aerobic Exercises on Persisted Post Burn Anemia

NCT ID: NCT06849479

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-03-31

Brief Summary

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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):

Detailed Description

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Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

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.

Group Type EXPERIMENTAL

Aerobic exercise and medical treatment

Intervention Type 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

Medical treatment group

Intervention Type 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 B

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.

Group Type PLACEBO_COMPARATOR

Medical treatment group

Intervention Type 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

Interventions

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Aerobic exercise and medical treatment

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

Intervention Type PROCEDURE

Medical treatment group

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

The subject selection will be according to the following criteria:

1. Ages of patients will be ranged from 20 to 35 years.
2. All patients underwent severe burn with TBSA ranged from 20% to 35%.
3. 8 th to 16th week post burn.
4. All patients will be referred with persisted anemia by a surgeon before starting the study procedure.
5. All patients will enter the study having their informed consent

Exclusion Criteria

The potential participants will be excluded if they meet one of the following criteria: 16

1. Patients with persisted pre burn anemia associated with systematic chronic disease such as coronary artery disease or chronic kidney disease.
2. Patients with pre burn persisted anemia associated with autoimmune disease such as Rheumatoid arthritis, Systemic lupus erythematosus ,Vasculitis, Sarcoidosis, Inflammatory bowel disease (IBD).
3. 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, .
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amira saad mohamed

lecturer of physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T.Rec/012/005217

Identifier Type: -

Identifier Source: org_study_id

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