- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07701213
Blood Flow Restriction and Aerobic Exercise in Iron Deficiency Anemia (BFR-IDA)
Impact of Blood Flow Restriction on Hematological Factors in Anemic Young Females
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: noha sameh donia, assisstant lecturer
- Telefonnummer: 01275600448
- E-Mail: nohasameh92.ns@gmail.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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.
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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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Aktiver 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.
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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haemoglobin concentration
Zeitfenster: Baseline and 12 weeks
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Baseline and 12 weeks
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Serum ferritin level
Zeitfenster: Baseline and at 12 weeks
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Baseline and at 12 weeks
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Haematocrit
Zeitfenster: Baseline and at 12 weeks
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Baseline and at 12 weeks
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Red blood cell (RBC) count
Zeitfenster: baseline and at 12 week
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baseline and at 12 week
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Mean corpuscular volume (MCV)
Zeitfenster: baseline and at 12 week
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baseline and at 12 week
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Mean corpuscular haemoglobin (MCH)
Zeitfenster: baseline and at 12 week
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baseline and at 12 week
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Functional capacity assessed using the Incremental Shuttle Walk Test (ISWT)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: baseline and at 12 week
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baseline and at 12 week
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Stoffwechselerkrankungen
- Hämatologische Erkrankungen
- Anämie
- Störungen des Eisenstoffwechsels
- Anämie, hypochrom
- Ernährungs- und Stoffwechselerkrankungen
- Hämische und lymphatische Krankheiten
- Eisenmangel
- Anämie, Eisenmangel
- Motorik
- Bewegung
- Phänomen des Bewegungsapparates muskuloskelettal
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Übung
Andere Studien-ID-Nummern
- P.T.REC/012/006440 (Andere Kennung: faculty of physical therapy cairo University ethical Committee)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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