Iron Deficiency AnemiaPhase 4NCT07605676
Acupoint TENS vs Resistance Training for Iron Deficiency Anemia
A Phase 4 study testing Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS), Resistance exercise training and Ferrous Sulfate in people with Iron Deficiency Anemia, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS), Resistance exercise training and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2026to 15 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Cairo
Rasha Abdullah Elbahi Ragab, MD, PhD, 0201008046808, Rasha_Ragab@med.kfs.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS), Resistance exercise training, Ferrous Sulfate, Iron-rich diet with vitamin C, Avoidance of iron absorption inhibitors
- Keywords
- Acupoint TENS, Resistance Exercise, Hemoglobin levels, Iron Deficiency Anemia
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS)Device
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 trainingBehavioural
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).
Ferrous SulfateDrug
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.
Iron-rich diet with vitamin CBehavioural
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.
Avoidance of iron absorption inhibitorsBehavioural
Participants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption.
| Study group | Role | What they receive |
|---|---|---|
| Study group (A) | Experimental | 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. Receives: Device: Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS); Drug: Ferrous Sulfate; Behavioral: Iron-rich diet with vitamin C; Behavioral: Avoidance of iron absorption inhibitors |
| Study group (B) | Experimental | ) Study group (B) includes 20 women with iron deficiency anemia who will undergo resistance exercise training in addition to routine medical treatment program. Receives: Behavioral: Resistance exercise training; Drug: Ferrous Sulfate; Behavioral: Iron-rich diet with vitamin C; Behavioral: Avoidance of iron absorption inhibitors |
| Control group (C) | Active comparator | Control group (C) includes 20 women with iron deficiency anemia who will receive routine medical treatment program only. Receives: Drug: Ferrous Sulfate; Behavioral: Iron-rich diet with vitamin C; Behavioral: Avoidance of iron absorption inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin concentration
Change in hemoglobin concentration (g/dL) measured before and after the intervention period.
Measured: 3 months
Secondary outcomes (6)
Change in red blood cell (RBC) count
Change in red blood cell (RBC) count measured before and after the 3-month intervention period.
Measured: Baseline to 3 months
Change in mean corpuscular volume (MCV)
Change in mean corpuscular volume (MCV) measured before and after the 3-month intervention period.
Measured: Baseline to 3 months
Change in serum ferritin level
Change in serum ferritin (ng/mL) measured before and after the 3-month intervention period.
Measured: Baseline to 3 months
Change in fatigue level
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.
Measured: Baseline to 3 months
Change in health-related quality of life
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.
Measured: Baseline to 3 months
Change in cardiorespiratory fitness
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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 Jan 2026
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Principal investigator, Dina Ebrahim Mohamed Aboshady, Kafrelsheikh University
- Investigators
- Dina Ebrahim Mohamed Aboshady, BSc PT, Study director, Faculty of Physical Therapy, Kafrelsheikh UniversityNagwa Mohamed Hamed Badr, PhD, Principal investigator, Cairo UniversityDina Ebrahim Mohamed Aboshady, BSc PT, Principal investigator, Faculty of Physical Therapy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605676
- Sponsor's protocol ID
- P.T.REC/012/006329
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation Versus Resistance Exercise on Hemoglobin Level in Women With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT07605676
- Acronym / sponsor ID
- P.T.REC/012/006329
- Conditions
- Iron Deficiency Anemia
- Keywords
- Acupoint TENS, Resistance Exercise, Hemoglobin levels, Iron Deficiency Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group (A) | Experimental | Device: Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS), Drug: Ferrous Sulfate, Behavioral: Iron-rich diet with vitamin C, Behavioral: Avoidance of iron absorption inhibitorsStudy 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. |
| Study group (B) | Experimental | Behavioral: Resistance exercise training, Drug: Ferrous Sulfate, Behavioral: Iron-rich diet with vitamin C, Behavioral: Avoidance of iron absorption inhibitors) Study group (B) includes 20 women with iron deficiency anemia who will undergo resistance exercise training in addition to routine medical treatment program. |
| Control group (C) | Active comparator | Drug: Ferrous Sulfate, Behavioral: Iron-rich diet with vitamin C, Behavioral: Avoidance of iron absorption inhibitorsControl group (C) includes 20 women with iron deficiency anemia who will receive routine medical treatment program only. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Study group (A) |
| Resistance exercise trainingResistance 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). | Behavioural | Study group (B) |
| Ferrous SulfateOral 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. | Drug | Control group (C), Study group (A), Study group (B) |
| Iron-rich diet with vitamin CDietary 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. | Behavioural | Control group (C), Study group (A), Study group (B) |
| Avoidance of iron absorption inhibitorsParticipants are advised to avoid tea, coffee, calcium, and antacids within 2 hours of iron intake to optimize absorption. | Behavioural | Control group (C), Study group (A), Study group (B) |
Primary outcome
Change in hemoglobin concentration
Time frame: 3 months
Change in hemoglobin concentration (g/dL) measured before and after the intervention period.
6 secondary outcomes
Change in red blood cell (RBC) count
Time frame: Baseline to 3 months
Change in mean corpuscular volume (MCV)
Time frame: Baseline to 3 months
Change in serum ferritin level
Time frame: Baseline to 3 months
Change in fatigue level
Time frame: Baseline to 3 months
Change in health-related quality of life
Time frame: Baseline to 3 months
Change in cardiorespiratory fitness
Time frame: Baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- BackgroundDivya 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
- BackgroundHegazy, 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dina Ebrahim Mohamed Aboshady, BSc PT study director
Faculty of Physical Therapy, Kafrelsheikh University
Nagwa Mohamed Hamed Badr, PhD principal investigator
Cairo University
Dina Ebrahim Mohamed Aboshady, BSc PT principal investigator
Faculty of Physical Therapy, Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acupuncture transcutaneous electrical nerve stimulation (Acu-TENS), Resistance exercise training and Ferrous Sulfate in people with Iron Deficiency Anemia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Ebrahim Mohamed Aboshady, BSc PT (0201010481505, dinaaboshady2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin concentration (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07605676, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.