Treadmill Aerobic Training and Quality of Life in Anemic Females (ATT-QoL-IDA)
2026년 6월 11일 업데이트: Mohamed Salah Saleh, Cairo University
Aerobic Treadmill Training Improves Exercise Tolerance and Health-Related Quality of Life in Young Adult Females With Iron Deficiency Anemia: A Randomized Controlled Trial
This randomized controlled trial investigates the effects of an 8-week structured treadmill aerobic training program on physical fitness and health-related quality of life in young adult females diagnosed with mild-to-moderate iron deficiency anemia.
Sixty participants are randomly allocated into two equal groups of thirty.
Group A (Experimental) receives standard daily oral iron therapy combined with a supervised moderate-intensity treadmill exercise program 3 times per week (30-40 minutes at 60-70% maximum heart rate).
Group B (Control) receives standard oral iron therapy with no structured exercise.
The study primary outcome measures the Physical Fitness Index (PFI) using the modified submaximal 3-minute Harvard Step Test, alongside secondary quality of life outcomes (SF-12 questionnaire), to prove that active cardiovascular training reverses physical deconditioning where iron supplements alone fall short.
연구 개요
상태
완전한
상세 설명
Iron deficiency anemia (IDA) is deeply associated with marked fatigue, diminished neuromuscular efficiency, and cardiorespiratory deconditioning. While standard medical management relies purely on pharmacological iron supplements to normalize hematological indices, this approach does not directly restore functional aerobic capacity or skeletal muscle utilization efficiency.
This study employs a parallel-group randomized controlled trial design (1:1 allocation) comparing two approaches over 8 consecutive weeks:
- Experimental Group (Group A, n=30): Standard physician-prescribed oral iron supplementation plus a structured moderate-intensity treadmill aerobic exercise program (3 sessions per week, progressing from 35 to 40 minutes at 60-70% max HR), alongside standard nutrition guidelines (the '2-Hour Rule' for iron absorption and daily Blackstrap Molasses).
- Control Group (Group B, n=30): Standard physician-prescribed oral iron supplementation and nutritional guidelines alone, with no structured exercise program.
Functional physical fitness is evaluated at baseline and post-treatment using the Physical Fitness Index (PFI) derived from the submaximal 3-minute Harvard Step Test. Health-related quality of life is assessed via the 12-item Short-Form Health Survey (SF-12), evaluating both Physical Component Summary (PCS) and Mental Component Summary (MCS) dimensions. The research evaluates whether systematic physical therapy/aerobic work is a mandatory adjuvant to reverse physical deconditioning in young females.
연구 유형
중재적
등록 (실제)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Damietta Governorate
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New Damietta, Damietta Governorate, 이집트, 34517
- Outpatient Clinics, Faculty of Physical Therapy, Horus University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age between 18 to 28 years.
- Biological females.
- Clinically diagnosed with mild-to-moderate Iron Deficiency Anemia (IDA), documented by laboratory Complete Blood Count (CBC) showing Hemoglobin (Hb) levels strictly between 9.0 and 12.0 g/dL, and serum ferritin levels ranging from 15 to 150 ng/mL.
- Hemodynamically stable and medically cleared to safely participate in moderate-intensity aerobic exercise.
- Regularly receiving physician-prescribed standard medical care (e.g., oral iron supplementation)
Exclusion Criteria:
- Severe anemia (Hemoglobin levels below 9.0 g/dL).
- Pregnancy or lactation.
- Chronic respiratory diseases, including bronchial asthma or COPD.
- Acute or chronic cardiovascular instability (e.g., severe arrhythmias, uncontrolled hypertension, or structural heart disease).
- Affected by chronic diseases or adhering to regular medication regimens (other than prescribed iron).
- Neurological or musculoskeletal disorders that mechanically limit the ability to walk on a treadmill or perform the step test safely.
- Experiencing acute illness, systemic infection, menorrhagia, irregular menstruation, or fever at the time of the study.
- Active participation in other structured, vigorous athletic training programs.
- Cognitive impairment affecting patient cooperation or the ability to understand the study questionnaires
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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 Training Group (Group A)
30 female patients who received an 8-week structured treadmill aerobic exercise training program (3 sessions/week, 35-40 minutes/session at 60-70% of Age-Predicted Maximum Heart Rate) in addition to standard medical care (oral iron supplementation) and a standardized nutritional protocol.
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Supervised progressive treadmill walking program for 8 weeks, 3 times/week.
Each session lasted 35-40 minutes including 5 minutes warm-up (at 2.0-3.0 km/h), 25-30 minutes active aerobic walking at 60-70% of age-predicted max HR, and 5 minutes cool-down.
All participants in both groups received standard physician-prescribed medical care (including oral iron supplementation) and a standardized, culturally tailored, cost-effective nutritional protocol rich in heme and non-heme iron with absorption enhancers (e.g., Vitamin C) and restriction of iron inhibitors.
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활성 비교기: Control Group (Group B)
30 female patients maintained on standard medical care (oral iron supplementation) and the standardized nutritional protocol, without participating in structured exercise.
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All participants in both groups received standard physician-prescribed medical care (including oral iron supplementation) and a standardized, culturally tailored, cost-effective nutritional protocol rich in heme and non-heme iron with absorption enhancers (e.g., Vitamin C) and restriction of iron inhibitors.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Physical Fitness Index (PFI)
기간: Baseline, Post-intervention (8 weeks)
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A numerical metric used to quantify cardiovascular efficiency and aerobic tolerance, mathematically derived from the post-exercise heart rate recovery profile following the submaximal 3-minute Modified Harvard Step Test (MHST) using the formula: PFI = (Duration of exercise in seconds x 100) / (2 x (PR1 + PR2 + PR3)).
Higher scores indicate better cardiovascular efficiency.
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Baseline, Post-intervention (8 weeks)
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Health-Related Quality of Life (HRQoL) - SF-12 Physical Component Summary (PCS)
기간: Baseline, Post-intervention (8 weeks)
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The physical component summary of the 12-Item Short Form Health Survey (SF-12) to evaluate physical quality of life, functional mobility, and physical role limitations.
Scores are calculated using a standardized scoring algorithm; higher scores indicate better physical well-being (range 0 to 100).
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Baseline, Post-intervention (8 weeks)
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Health-Related Quality of Life (HRQoL) - SF-12 Mental Component Summary (MCS)
기간: Baseline, Post-intervention (8 weeks)
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The mental component summary of the 12-Item Short Form Health Survey (SF-12) to evaluate mental well-being, psychological domains, and emotional status.
Scores are calculated using a standardized scoring algorithm; higher scores indicate better mental well-being (range 0 to 100).
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Baseline, Post-intervention (8 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Estimated Maximal Oxygen Consumption (VO2max)
기간: Baseline, Post-intervention (8 weeks)
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Systemic oxygen utilization capacity indirectly estimated using 1-minute post-exercise recovery heart rate data extracted from the submaximal 3-minute Modified Harvard Step Test (MHST) using the formula: VO2max (ml/kg/min) = 65.81 - (0.1847 x HRrecovery).
Higher values indicate better aerobic capacity.
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Baseline, Post-intervention (8 weeks)
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Fatigue Severity (FACIT-Fatigue)
기간: Baseline, Post-intervention (8 weeks)
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Subjective severity of pathological fatigue measured using the 13-item Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
Patients rate statements regarding fatigue over the past 7 days on a 4-point Likert scale.
Total scores range from 0 to 52, where higher scores indicate less fatigue and better quality of life.
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Baseline, Post-intervention (8 weeks)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
수사관
- 연구 의자: Nesreen Gharib Elnahas, Prof. Dr., Cairo University
- 연구 책임자: Farag A. Ali, Prof. Dr., Cairo University
- 연구 책임자: Asmaa Mohammed Sharabash, Assistant Professor, Cairo University
- 수석 연구원: Mohamed Salah Saleh, M.Sc., Cairo University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 11월 15일
기본 완료 (실제)
2026년 1월 15일
연구 완료 (실제)
2026년 1월 15일
연구 등록 날짜
최초 제출
2026년 6월 11일
QC 기준을 충족하는 최초 제출
2026년 6월 11일
처음 게시됨 (실제)
2026년 6월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 11일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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