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

8. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Fremgangsmåte: 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.

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cairo University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

25. juli 2026

Primær fullføring (Antatt)

30. oktober 2026

Studiet fullført (Antatt)

5. november 2026

Datoer for studieregistrering

Først innsendt

2. juli 2026

Først innsendt som oppfylte QC-kriteriene

8. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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