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Acupoint TENS vs Resistance Training for Iron Deficiency Anemia

ConditionIron Deficiency Anemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-30
SponsorCairo University

About this trial

The current study is designed to compare between the effect of transcutaneous electrical acupoint stimulation and resistance exercises on hemoglobin level in women with iron deficiency anemia.The design of this study will be a randomized controlled trial (RCT) pretest post-test assessment.Sixty women diagnosed with iron deficiency anemia will be recruited in this study from Kafrelshiekh University Hospital, Kafrelshiekh Governorate, Egypt. Their ages will be ranged from 20 to 30 years old, and they will be randomly divided into three equal (n= 20) groups. Change in hemoglobin concentration (g/dL) after the intervention period and changes in RBC count, MCV, MCH, RDW, serum ferritin, fatigue level, and functional exercise capacity after treatment will be measured.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sixty women diagnosed with iron deficiency anemia within ≤6 months.

Their hemoglobin concentrations ranging from 8.0 to 10.9 g/dL that classified as moderate anemia in accordance with the World Health Organization (WHO) criteria.

The iron deficiency anemia resulted from the heavy monthly bleeding of menstrual cycle as reported by the women.

Their age will be ranged from 20 and 30 years old.

Disqualifiers

Other causes of anemia (e.g., hemolytic anemia, anemia of chronic disease, megaloblastic anemia, thalassemia, or sickle cell disease).

Severe anemia (hemoglobin < 8.0 g/dL)

History of chronic kidney disease, liver disease, or malignancy.

Current pregnancy or lactation, due to altered iron metabolism and hemoglobin thresholds.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS)

    Device

    This technique will be applied to the study group (A) only as follow: In the Acu-TENS group, electrodes of the TENS device will be applied over bilateral gall bladder 39 (on the lateral aspect of the lower leg, 3 cun above the tip of the external malleolus, on the anterior border of the fibula) and spleen 6 (a width of four fingers above the medial malleolus on the posterior border of the tibia)

  • Resistance exercise training

    Behavioral

    Resistance exercise training: This type of exercise training will be applied to the study group (B) only as follow: Resistance exercise is commonly prescribed using the FITT principle (Frequency, Intensity, Time, and Type).Multi-joint resistance exercises covering major muscle groups (legs, back, arms, core), by using free weights for legs and arms, body weight through (squats, lunges and pushups).

  • Ferrous Sulfate

    Drug

    Oral iron supplementation using ferrous sulfate 325 mg (approximately 65 mg elemental iron) administered as a single morning dose, preferably on alternate days, to optimize iron absorption and minimize gastrointestinal side effects based on current clinical recommendations.

  • Iron-rich diet with vitamin C

    Behavioral

    Dietary intervention including increased intake of iron-rich foods (such as red meat and legumes) along with vitamin C-rich foods (such as citrus fruits) to enhance iron absorption.

  • Avoidance of iron absorption inhibitors

    Behavioral

    Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Study group (A)Experimental treatment 4 interventions
Group B: Study group (B)Experimental treatment 4 interventions
Group C: Control group (C)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in hemoglobin concentration

Change in hemoglobin concentration (g/dL) measured before and after the intervention period.

Time frame
3 months

Secondary outcomes

1

Change in red blood cell (RBC) count

Change in red blood cell (RBC) count measured before and after the 3-month intervention period.

Time frame
Baseline to 3 months
2

Change in mean corpuscular volume (MCV)

Change in mean corpuscular volume (MCV) measured before and after the 3-month intervention period.

Time frame
Baseline to 3 months
3

Change in serum ferritin level

Change in serum ferritin (ng/mL) measured before and after the 3-month intervention period.

Time frame
Baseline to 3 months
4

Change in fatigue level

Change in fatigue level assessed using the Fatigue Severity Scale (FSS). The FSS consists of 9 items, each scored from 1 to 7, with total scores calculated as the average of all items. Higher scores indicate greater fatigue severity.

Time frame
Baseline to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Kafrelsheikh University

Sponsor institution

Kafrelsheikh University

Collaborator

Source ClinicalTrials.gov
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