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Acupoint TENS vs Resistance Training for Iron Deficiency Anemia

18. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Ägypten
      • Cairo, Ägypten
        • Rekrutierung
        • Kafrelsheikh University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: 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)
Arzneimittel: 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.
Verhalten: 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.
Verhalten: Avoidance of iron absorption inhibitors
Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.
Experimental: 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.
Arzneimittel: 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.
Verhalten: 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.
Verhalten: Avoidance of iron absorption inhibitors
Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.
Verhalten: 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).
Aktiver Komparator: Control group (C)
Control group (C) includes 20 women with iron deficiency anemia who will receive routine medical treatment program only.
Arzneimittel: 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.
Verhalten: 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.
Verhalten: Avoidance of iron absorption inhibitors
Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in hemoglobin concentration
Zeitfenster: 3 months
Change in hemoglobin concentration (g/dL) measured before and after the intervention period.
3 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in red blood cell (RBC) count
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Cairo University

Mitarbeiter

Kafrelsheikh University

Ermittler

  • Studienleiter: Dina Ebrahim Mohamed Aboshady, BSc PT, Faculty of Physical Therapy, Kafrelsheikh University
  • Hauptermittler: Nagwa Mohamed Hamed Badr, PhD, Cairo University
  • Hauptermittler: Dina Ebrahim Mohamed Aboshady, BSc PT, Faculty of Physical Therapy, Kafrelsheikh University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

  • 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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Januar 2026

Primärer Abschluss (Geschätzt)

15. August 2026

Studienabschluss (Geschätzt)

15. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

8. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Mai 2026

Zuerst gepostet (Tatsächlich)

26. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • P.T.REC/012/006329

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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