- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Dina Ebrahim Mohamed Aboshady, BSc PT
- Phone Number: 0201010481505
- Email: dinaaboshady2020@gmail.com
Study Contact Backup
- Name: El-Sayed Essam El-Sayed Felaya, PhD
- Phone Number: 0201007099643
- Email: Elsayedessam22@yahoo.com
Study Locations
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Cairo, Egypt
- Recruiting
- Kafrelsheikh University
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Contact:
- Rasha Abdullah Elbahi Ragab, MD, PhD
- Phone Number: 0201008046808
- Email: Rasha_Ragab@med.kfs.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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.
|
|
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.
|
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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Active Comparator: Control group (C)
Control group (C) includes 20 women with iron deficiency anemia who will receive routine medical treatment program only.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in hemoglobin concentration
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in red blood cell (RBC) count
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Dina Ebrahim Mohamed Aboshady, BSc PT, Faculty of Physical Therapy, Kafrelsheikh University
- Principal Investigator: Nagwa Mohamed Hamed Badr, PhD, Cairo university
- Principal Investigator: Dina Ebrahim Mohamed Aboshady, BSc PT, Faculty of Physical Therapy, Kafrelsheikh University
Publications and helpful links
General Publications
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Hematologic Diseases
- Anemia
- Iron Metabolism Disorders
- Anemia, Hypochromic
- Nutritional and Metabolic Diseases
- Hemic and Lymphatic Diseases
- Iron Deficiencies
- Anemia, Iron-Deficiency
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Organic Chemicals
- Therapeutics
- Physical Therapy Modalities
- Carbohydrates
- Sugar Acids
- Acids, Acyclic
- Carboxylic Acids
- Hydroxy Acids
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Ascorbic Acid
- Resistance Training
- ferrous sulfate
Other Study ID Numbers
- P.T.REC/012/006329
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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