Kafrelsheikh University
Cairo, Egypt
Location status: Recruiting
NCT Number: NCT07605676
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.
Interested in participating?
Request Info20 year–30 year
Female
Interventional
Phase 4
Cairo, Egypt
Location status: Recruiting
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:
The treatment program will be applied once per day, three times per week for 12 consecutive weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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).
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.
Time frame: 3 months
Change in hemoglobin concentration (g/dL) measured before and after the intervention period.
Time frame: Baseline to 3 months
Change in red blood cell (RBC) count measured before and after the 3-month intervention period.
Time frame: Baseline to 3 months
Change in mean corpuscular volume (MCV) measured before and after the 3-month intervention period.
Time frame: Baseline to 3 months
Change in serum ferritin (ng/mL) measured before and after the 3-month intervention period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Dina Ebrahim Mohamed Aboshady, BSc PT
CONTACT
El-Sayed Essam El-Sayed Felaya, PhD
CONTACT
Cairo University
Other
Effect of Transcutaneous Electrical Acupoint Stimulation Versus Resistance Exercise on Hemoglobin Level in Women With Iron Deficiency Anemia
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