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Not yet recruiting NCT07701213

Blood Flow Restriction and Aerobic Exercise in Iron Deficiency Anemia

No phase Interventional Iron Deficiency Anaemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: aerobic exercise + blood flow restriction, aerobic exercise.
Who it may be relevant to
Registry conditions: Iron Deficiency Anaemia. Basic parameters: 19 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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
  • 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.

Primary outcome measures

  • haemoglobin concentration [Time frame: Baseline and 12 weeks]
  • Serum ferritin level [Time frame: Baseline and at 12 weeks]
  • Haematocrit [Time frame: Baseline and at 12 weeks]
  • Red blood cell (RBC) count [Time frame: baseline and at 12 week]
  • Mean corpuscular volume (MCV) [Time frame: baseline and at 12 week]
  • Mean corpuscular haemoglobin (MCH) [Time frame: baseline and at 12 week]
Secondary outcome measures (3)
  • Functional capacity assessed using the Incremental Shuttle Walk Test (ISWT) [Time frame: baseline and at 12 week]
  • Quality of life assessed using the SF-36 questionnaire [Time frame: baseline and at 12 week]
  • Estimated maximal oxygen consumption (VO₂max) derived from the ISWT [Time frame: baseline and at 12 week]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07701213 · P.T.REC/012/006440 · P.T.REC/012/006440

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗