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Recruiting NCT07605676

Acupoint TENS vs Resistance Training for Iron Deficiency Anemia

Phase IV Interventional Iron Deficiency Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS), Resistance exercise training, Ferrous Sulfate, Iron-rich diet with vitamin C.
Who it may be relevant to
Registry conditions: Iron Deficiency Anemia. Basic parameters: 20 years — 30 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Transcutaneous Electrical Acupoint Stimulation Versus Resistance Exercise on Hemoglobin Level in Women With Iron Deficiency Anemia

Overview

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.

Detailed description

Iron deficiency anemia (IDA) is one of the most common nutritional disorders among women and is associated with fatigue, weakness, reduced physical performance, and impaired quality of life. Non-pharmacological interventions such as Transcutaneous Electrical Nerve Stimulation (TENS) applied on acupuncture points such as gall bladder 39 and spleen 6 and resistance exercise may help improve circulation, stimulate physiological responses, and support hemoglobin production.This study is randomized controlled trial (RCT) pretest post test assessment aimed to compare the effects of acupoint TENS and resistance exercise on hemoglobin levels in women with iron deficiency anemia.Sixty women diagnosed with iron deficiency anemia will be recruited in this study . Their ages will be ranged from 20 to 30 years old, and they will be randomly divided into three equal (n= 20) groups as following:

1. Study group (A) includes 20 women who will receive acupuncture transcutaneous electrical nerve stimulation (Acu-TENS) in addition to routine medical treatment program. 2. Study group (B) includes 20 women who will undergo resistance exercise training in addition to routine medical treatment program. 3. Control group (C) includes 20 women who will receive routine medical treatment program only.

The treatment program will be applied once per day, three times per week for 12 consecutive weeks.

Interventions

  • Device Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS)
    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)
  • Behavioral Resistance exercise training
    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).
  • Drug Ferrous Sulfate
    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.
  • Behavioral Iron-rich diet with vitamin C
    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.
  • Behavioral Avoidance of iron absorption inhibitors
    Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.

Primary outcome measures

  • Change in hemoglobin concentration [Time frame: 3 months]
Secondary outcome measures (6)
  • Change in red blood cell (RBC) count [Time frame: Baseline to 3 months]
  • Change in mean corpuscular volume (MCV) [Time frame: Baseline to 3 months]
  • Change in serum ferritin level [Time frame: Baseline to 3 months]
  • Change in fatigue level [Time frame: Baseline to 3 months]
  • Change in health-related quality of life [Time frame: Baseline to 3 months]
  • Change in cardiorespiratory fitness [Time frame: Baseline to 3 months]

Eligibility criteria

Inclusion criteria

  • 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.
  • Their BMI will be ranged from 18.5 to 24.9 kg/m².
  • They will have the same level of functional capacity assessed by 6-minute walking test.
  • They will be receiving the same medical treatment programme.

Exclusion criteria

  • 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.
  • Recent blood transfusion or iron therapy (oral or intravenous) within the past 3 months.
  • Use of hematopoietic agents (e.g., erythropoietin).
  • Acute infection or inflammatory conditions at the time of enrollment.
  • Inability or unwillingness to provide informed consent or comply with study procedures.
  • Previous participation in complementary treatments/research within the last six months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Kafrelsheikh University — Cairo

Publications

  • Divya Mary, S. M., & Priyadharshini, P. (2022). Impact of resistance exercise versus diet supplements on iron deficiency anemia in girls. International Journal of Medical and Exercise Science, 8(2), 1302-1310. DOI:10.36678/IJMAES.2022.V08I02.006
  • Hegazy, M., Obaya, H., Mohamed, F., & Draz, R. (2024). Effect of transcutaneous electrical acupoint stimulation versus aerobic exercise on iron deficiency anemic females. Bulletin of International Journal of Physiotherapy, 2(2), 28-34. https://doi.org/10.21608/BIJPT.2024.304165.1036

Identifiers

NCT: NCT07605676 · P.T.REC/012/006329

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗