- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: noha sameh donia, assisstant lecturer
- 전화번호: 01275600448
- 이메일: nohasameh92.ns@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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haemoglobin concentration
기간: Baseline and 12 weeks
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Baseline and 12 weeks
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Serum ferritin level
기간: Baseline and at 12 weeks
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Baseline and at 12 weeks
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Haematocrit
기간: Baseline and at 12 weeks
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Baseline and at 12 weeks
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Red blood cell (RBC) count
기간: baseline and at 12 week
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baseline and at 12 week
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Mean corpuscular volume (MCV)
기간: baseline and at 12 week
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baseline and at 12 week
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Mean corpuscular haemoglobin (MCH)
기간: baseline and at 12 week
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baseline and at 12 week
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Functional capacity assessed using the Incremental Shuttle Walk Test (ISWT)
기간: 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
기간: 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
기간: baseline and at 12 week
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baseline and at 12 week
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P.T.REC/012/006440 (기타 식별자: faculty of physical therapy cairo University ethical Committee)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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