Acupoint TENS vs Resistance Training for Iron Deficiency Anemia

NCT07605676 | Recruiting Phase 4 DMC

• 1 other identifier: P.T.REC/012/006329
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anemia

Keywords

Acupoint TENS; Resistance Exercise; Hemoglobin levels; Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin concentration

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

  3 months

Secondary Outcomes (6)

• Change in red blood cell (RBC) count

  Baseline to 3 months

• Change in mean corpuscular volume (MCV)

  Baseline to 3 months

• Change in serum ferritin level

  Baseline to 3 months

• Change in fatigue level

  Baseline to 3 months

• Change in health-related quality of life

  Baseline to 3 months

Study Arms (3)

Study group (A)

EXPERIMENTAL

Study group (A) includes 20 women with iron deficiency anemia who will receive acupuncture transcutaneous electrical nerve stimulation (Acu-TENS) in addition to a routine medical treatment program.

Device: Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS); Drug: Ferrous Sulfate; Behavioral: Iron-rich diet with vitamin C; Behavioral: Avoidance of iron absorption inhibitors

Study group (B)

EXPERIMENTAL

) Study group (B) includes 20 women with iron deficiency anemia who will undergo resistance exercise training in addition to routine medical treatment program.

Behavioral: Resistance exercise training; Drug: Ferrous Sulfate; Behavioral: Iron-rich diet with vitamin C; Behavioral: Avoidance of iron absorption inhibitors

Control group (C)

ACTIVE COMPARATOR

Control group (C) includes 20 women with iron deficiency anemia who will receive routine medical treatment program only.

Drug: Ferrous Sulfate; Behavioral: Iron-rich diet with vitamin C; Behavioral: Avoidance of iron absorption inhibitors

Interventions

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)

Study group (A)

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).

Study group (B)

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.

Control group (C); Study group (A); Study group (B)

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.

Control group (C); Study group (A); Study group (B)

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.

Control group (C); Study group (A); Study group (B)

Eligibility Criteria

• Age: 20 Years - 30 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Kafrelsheikh University: collaborator

Study Sites (1)

Kafrelsheikh University

Cairo, Egypt

RECRUITING

Related Publications (2)

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Resistance Training; ferrous sulfate; Ascorbic Acid

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Dina Ebrahim Mohamed Aboshady, BSc PT

  Faculty of Physical Therapy, Kafrelsheikh University

  STUDY DIRECTOR

• Nagwa Mohamed Hamed Badr, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Dina Ebrahim Mohamed Aboshady, BSc PT

  Faculty of Physical Therapy, Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina Ebrahim Mohamed Aboshady, BSc PT

CONTACT

0201010481505; dinaaboshady2020@gmail.com

El-Sayed Essam El-Sayed Felaya, PhD

CONTACT

0201007099643; Elsayedessam22@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 26, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

EG (1)