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Acupoint TENS vs Resistance Training for Iron Deficiency Anemia

18 maggio 2026 aggiornato da: Dina Ebrahim Mohamed Aboshady, Cairo University

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Egitto
      • Cairo, Egitto
        • Reclutamento
        • Kafrelsheikh University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Study group (A)
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.
Dispositivo: 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)
Droga: 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.
Comportamentale: 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.
Comportamentale: Avoidance of iron absorption inhibitors
Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.
Sperimentale: Study group (B)
) Study group (B) includes 20 women with iron deficiency anemia who will undergo resistance exercise training in addition to routine medical treatment program.
Droga: 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.
Comportamentale: 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.
Comportamentale: Avoidance of iron absorption inhibitors
Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.
Comportamentale: 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).
Comparatore attivo: Control group (C)
Control group (C) includes 20 women with iron deficiency anemia who will receive routine medical treatment program only.
Droga: 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.
Comportamentale: 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.
Comportamentale: Avoidance of iron absorption inhibitors
Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in hemoglobin concentration
Lasso di tempo: 3 months
Change in hemoglobin concentration (g/dL) measured before and after the intervention period.
3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in red blood cell (RBC) count
Lasso di tempo: Baseline to 3 months
Change in red blood cell (RBC) count measured before and after the 3-month intervention period.
Baseline to 3 months
Change in mean corpuscular volume (MCV)
Lasso di tempo: Baseline to 3 months
Change in mean corpuscular volume (MCV) measured before and after the 3-month intervention period.
Baseline to 3 months
Change in serum ferritin level
Lasso di tempo: Baseline to 3 months
Change in serum ferritin (ng/mL) measured before and after the 3-month intervention period.
Baseline to 3 months
Change in fatigue level
Lasso di tempo: Baseline to 3 months
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.
Baseline to 3 months
Change in health-related quality of life
Lasso di tempo: Baseline to 3 months
Change in health-related quality of life assessed using the Short Form-36 (SF-36) Health Survey. The SF-36 includes 36 items covering 8 domains, with each domain scored from 0 to 100. Higher scores indicate better health status and quality of life.
Baseline to 3 months
Change in cardiorespiratory fitness
Lasso di tempo: Baseline to 3 months
Change in cardiorespiratory fitness assessed using the 6-Minute Walk Test (6MWT). The test measures the total distance walked in meters over 6 minutes, with higher distances indicating better functional exercise capacity and cardiorespiratory fitness.
Baseline to 3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cairo University

Collaboratori

Kafrelsheikh University

Investigatori

  • Direttore dello studio: Dina Ebrahim Mohamed Aboshady, BSc PT, Faculty of Physical Therapy, Kafrelsheikh University
  • Investigatore principale: Nagwa Mohamed Hamed Badr, PhD, Cairo University
  • Investigatore principale: Dina Ebrahim Mohamed Aboshady, BSc PT, Faculty of Physical Therapy, Kafrelsheikh University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • 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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 gennaio 2026

Completamento primario (Stimato)

15 agosto 2026

Completamento dello studio (Stimato)

15 ottobre 2026

Date di iscrizione allo studio

Primo inviato

8 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • P.T.REC/012/006329

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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