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Blood Flow Restriction and Aerobic Exercise in Iron Deficiency Anemia (BFR-IDA)
Impact of Blood Flow Restriction on Hematological Factors in Anemic Young Females
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: noha sameh donia, assisstant lecturer
- Telefoonnummer: 01275600448
- E-mail: nohasameh92.ns@gmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
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Actieve vergelijker: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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haemoglobin concentration
Tijdsspanne: Baseline and 12 weeks
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Baseline and 12 weeks
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Serum ferritin level
Tijdsspanne: Baseline and at 12 weeks
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Baseline and at 12 weeks
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Haematocrit
Tijdsspanne: Baseline and at 12 weeks
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Baseline and at 12 weeks
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Red blood cell (RBC) count
Tijdsspanne: baseline and at 12 week
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baseline and at 12 week
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Mean corpuscular volume (MCV)
Tijdsspanne: baseline and at 12 week
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baseline and at 12 week
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Mean corpuscular haemoglobin (MCH)
Tijdsspanne: baseline and at 12 week
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baseline and at 12 week
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Functional capacity assessed using the Incremental Shuttle Walk Test (ISWT)
Tijdsspanne: baseline and at 12 week
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baseline and at 12 week
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Quality of life assessed using the SF-36 questionnaire
Tijdsspanne: baseline and at 12 week
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baseline and at 12 week
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Estimated maximal oxygen consumption (VO₂max) derived from the ISWT
Tijdsspanne: baseline and at 12 week
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baseline and at 12 week
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Metabole ziekten
- Hematologische ziekten
- Bloedarmoede
- Stoornissen in het ijzermetabolisme
- Bloedarmoede, hypochroom
- Voedings- en stofwisselingsziekten
- Hemische en lymfatische ziekten
- IJzertekorten
- Bloedarmoede, ijzertekort
- Motorische activiteit
- Beweging
- Musculoskeletale fysiologische fenomenen
- Musculoskeletale en neurale fysiologische fenomenen
- Oefening
Andere studie-ID-nummers
- P.T.REC/012/006440 (Andere identificatie: faculty of physical therapy cairo University ethical Committee)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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