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

8. juli 2026 opdateret af: noha sameh, Cairo University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
haemoglobin concentration
Tidsramme: Baseline and 12 weeks
Baseline and 12 weeks
Serum ferritin level
Tidsramme: Baseline and at 12 weeks
Baseline and at 12 weeks
Haematocrit
Tidsramme: Baseline and at 12 weeks
Baseline and at 12 weeks
Red blood cell (RBC) count
Tidsramme: baseline and at 12 week
baseline and at 12 week
Mean corpuscular volume (MCV)
Tidsramme: baseline and at 12 week
baseline and at 12 week
Mean corpuscular haemoglobin (MCH)
Tidsramme: baseline and at 12 week
baseline and at 12 week

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. juli 2026

Primær færdiggørelse (Anslået)

30. oktober 2026

Studieafslutning (Anslået)

5. november 2026

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P.T.REC/012/006440 (Anden identifikator: faculty of physical therapy cairo University ethical Committee)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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