- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07605676
Acupoint TENS vs Resistance Training for Iron Deficiency Anemia
Effect of Transcutaneous Electrical Acupoint Stimulation Versus Resistance Exercise on Hemoglobin Level in Women With Iron Deficiency Anemia
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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:
- Study group (A) includes 20 women who will receive acupuncture transcutaneous electrical nerve stimulation (Acu-TENS) in addition to routine medical treatment program.
- Study group (B) includes 20 women who will undergo resistance exercise training in addition to routine medical treatment program.
- 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Dina Ebrahim Mohamed Aboshady, BSc PT
- Telefonnummer: 0201010481505
- E-mail: dinaaboshady2020@gmail.com
Undersøgelse Kontakt Backup
- Navn: El-Sayed Essam El-Sayed Felaya, PhD
- Telefonnummer: 0201007099643
- E-mail: Elsayedessam22@yahoo.com
Studiesteder
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Cairo, Egypten
- Rekruttering
- Kafrelsheikh University
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Kontakt:
- Rasha Abdullah Elbahi Ragab, MD, PhD
- Telefonnummer: 0201008046808
- E-mail: Rasha_Ragab@med.kfs.edu.eg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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)
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.
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.
Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.
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Eksperimentel: 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.
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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.
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.
Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.
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).
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Aktiv komparator: Control group (C)
Control group (C) includes 20 women with iron deficiency anemia who will receive routine medical treatment program only.
|
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.
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.
Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in hemoglobin concentration
Tidsramme: 3 months
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Change in hemoglobin concentration (g/dL) measured before and after the intervention period.
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3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in red blood cell (RBC) count
Tidsramme: Baseline to 3 months
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Change in red blood cell (RBC) count measured before and after the 3-month intervention period.
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Baseline to 3 months
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Change in mean corpuscular volume (MCV)
Tidsramme: Baseline to 3 months
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Change in mean corpuscular volume (MCV) measured before and after the 3-month intervention period.
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Baseline to 3 months
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Change in serum ferritin level
Tidsramme: Baseline to 3 months
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Change in serum ferritin (ng/mL) measured before and after the 3-month intervention period.
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Baseline to 3 months
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Change in fatigue level
Tidsramme: Baseline to 3 months
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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.
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Baseline to 3 months
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Change in health-related quality of life
Tidsramme: Baseline to 3 months
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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.
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Baseline to 3 months
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Change in cardiorespiratory fitness
Tidsramme: Baseline to 3 months
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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.
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Baseline to 3 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Dina Ebrahim Mohamed Aboshady, BSc PT, Faculty of Physical Therapy, Kafrelsheikh University
- Ledende efterforsker: Nagwa Mohamed Hamed Badr, PhD, Cairo University
- Ledende efterforsker: Dina Ebrahim Mohamed Aboshady, BSc PT, Faculty of Physical Therapy, Kafrelsheikh University
Publikationer og nyttige links
Generelle publikationer
- 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
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Metaboliske sygdomme
- Hæmatologiske sygdomme
- Anæmi
- Forstyrrelser i jernmetabolisme
- Anæmi, hypokromisk
- Ernæringsmæssige og metaboliske sygdomme
- Hemiske og lymfatiske sygdomme
- Jernmangel
- Anæmi, jernmangel
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Organiske kemikalier
- Terapeutik
- Fysioterapimodaliteter
- Kulhydrater
- Sukkersyrer
- Syrer, acyklisk
- Carboxylsyrer
- Hydroxy -syrer
- Patientpleje
- Træningsterapi
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Fysisk konditionering, menneske
- Øvelse
- Ascorbinsyre
- Modstandstræning
- jernsulfat
Andre undersøgelses-id-numre
- P.T.REC/012/006329
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