Blood Flow Restriction and Aerobic Exercise in Iron Deficiency Anemia (BFR-IDA)

Impact of Blood Flow Restriction on Hematological Factors in Anemic Young Females

Preventing iron deficiency anemia is essential for strengthening adolescent health and ensuring their full development. Strategies such as improving nutrition, expanding the availability of iron-fortified products, implementing pharmacological prevention, and raising awareness play a crucial role in addressing this issue.

Study Overview

• Status: Not yet recruiting
• Conditions: Iron Deficiency Anaemia
• Intervention / Treatment: Device: aerobic exercise + blood flow restriction; Procedure: aerobic exercise

Detailed Description

Anemia is a global public health problem affecting both developing and developed countries at all ages, with major consequences for human health as well as social and economic burden. Iron deficiency affects more than 2 billion people world wide, and iron deficiency anemia (IDA) remains to be the top cause of anemia.

For decades, blood flow restriction (BFR), originating from Japan, has become one of the most popular techniques in physiotherapy. To perform the BFR technique, a controlled tourniquet is performed, generating a gradual mechanical pressure just below it, affecting blood flow (both arterial and venous) and generating a hypoxia in the restricted area. For the realization of the tourniquet, mechanical cuffs are used, which are inflated and regulate the pressure generated in the compression zone, although nylon or elastic cuffs are also used for the realization of the tourniquet.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: noha sameh donia, assisstant lecturer; Phone Number: 01275600448; Email: nohasameh92.ns@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Hb more than 8 and less than 12 in females.
2. Age: 19-25 year.
3. BMI ranging from 25 to 29.9 kg/m2.
4. No existing inflammatory conditions including rheumatoid arthritis disorders of the lower extremities.
5. Physical activity level less than 150 min per week

Exclusion Criteria:

1. unstable hypertension, venous thromboembolism, hypercoagulable states, varicose veins, pregnancy, and hemophilia.
2. inherited or acquired red cell disorders (haemoglobinopathies).
3. acute or chronic infections (malaria, tuberculosis, HIV),.
4. severe anemia (Hb <8 g/dL).
5. History of cardiovascular diseases.
6. Nutritional anemia (B12/folate)
7. Pregnancy.
8. Peripheral arterial disease.
9. Intermittent claudication.
10. Non smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic Exercise + Blood Flow Restriction; 25 female will receive blood flow restriction with low intensity aerobic exercise participated in 3 months exercise training protocol, which included three walking training sessions per week on a treadmill set at a speed 3 km/h. They experienced 3 session/week and each session include 5-10 minutes warming up and five training sets (each lasting 2 min) with a 1 min rest period between each exercise session and ended with 5-10 minutes cooling down A pressure of between 140 and 200 mmHg was applied using a sphygmomanometer cuff placed at the thigh of the BFR group.	Device: aerobic exercise + blood flow restriction; Twenty five females will be subjected to supervised blood flow restriction combined with aerobic exercise program. participated in 3 months exercise training protocol, which included three walking training sessions per week on a treadmill set at a speed 3 km/h. They experienced 3 session/week and each session include 5-10 minutes .A pressure of between 140 and 200 mmHg was applied using a sphygmomanometer cuff placed at the thigh of the BFR group. The pressure of the cuff was increased until the participants adapted to the restriction stimulus during the early phase of training, and this pressure was maintained used during the training protocol. The strap pressure was increased by 10 mmHg per week, such that it reached 200 mmHg by the end of 12th week. The pressure on the thigh strap was abruptly released after five completions of the exercise set.
Active Comparator: Aerobic Exercise; 25 subject participated in 3 months exercise training protocol, which included three walking training sessions per week on a treadmill set at a speed 3 km/h. They experienced 3 session/week and each session include 5-10 minutes warming up and five training sets (each lasting 2 min) with a 1 min rest period between each exercise session and ended with 5-10 minutes cooling down.	Procedure: aerobic exercise; participated in 3 months exercise training protocol, which included three walking training sessions per week on a treadmill set at a speed 3 km/h. They experienced 3 session/week and each session include 5-10 minutes warming up and five training sets (each lasting 2 min) with a 1 min rest period between each exercise session and ended with 5-10 minutes cooling down.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
haemoglobin concentration	Baseline and 12 weeks
Serum ferritin level	Baseline and at 12 weeks
Haematocrit	Baseline and at 12 weeks
Red blood cell (RBC) count	baseline and at 12 week
Mean corpuscular volume (MCV)	baseline and at 12 week
Mean corpuscular haemoglobin (MCH)	baseline and at 12 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional capacity assessed using the Incremental Shuttle Walk Test (ISWT)	baseline and at 12 week
Quality of life assessed using the SF-36 questionnaire	baseline and at 12 week
Estimated maximal oxygen consumption (VO₂max) derived from the ISWT	baseline and at 12 week

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): July 25, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 5, 2026

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Iron Deficiency Anemia; blood flow restriction
• 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; Exercise
• Other Study ID Numbers: P.T.REC/012/006440 (Other Identifier: faculty of physical therapy cairo University ethical Committee)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No