Acupoint TENS vs Resistance Training for Iron Deficiency Anemia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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)
• Поведенческое 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).
• Препарат 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.
• Поведенческое 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.
• Поведенческое Avoidance of iron absorption inhibitors
  Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.

Первичные конечные точки

• Change in hemoglobin concentration [Срок оценки: 3 months]

Вторичные конечные точки (6)

• Change in red blood cell (RBC) count [Срок оценки: Baseline to 3 months]
• Change in mean corpuscular volume (MCV) [Срок оценки: Baseline to 3 months]
• Change in serum ferritin level [Срок оценки: Baseline to 3 months]
• Change in fatigue level [Срок оценки: Baseline to 3 months]
• Change in health-related quality of life [Срок оценки: Baseline to 3 months]
• Change in cardiorespiratory fitness [Срок оценки: Baseline to 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Kafrelsheikh University — Cairo

Публикации

• 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

Идентификаторы

NCT: NCT07605676 · P.T.REC/012/006329

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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