Aerobic Treadmill Training Improves Exercise Tolerance and Health-Related Quality of Life in Young Adult Females With Iron Deficiency Anemia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Physical Fitness Index (PFI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Treadmill Aerobic Exercise (Behavioral)
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.
干预措施: Standard Medical Care and Nutritional Protocol (Other)
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.
干预措施: Standard Medical Care and Nutritional Protocol (Other)
结局指标
主要结局
Physical Fitness Index (PFI)
时间窗: Baseline, Post-intervention (8 weeks)
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.
Health-Related Quality of Life (HRQoL) - SF-12 Physical Component Summary (PCS)
时间窗: Baseline, Post-intervention (8 weeks)
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).
Health-Related Quality of Life (HRQoL) - SF-12 Mental Component Summary (MCS)
时间窗: Baseline, Post-intervention (8 weeks)
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).
次要结局
- Estimated Maximal Oxygen Consumption (VO2max)(Baseline, Post-intervention (8 weeks))
- Fatigue Severity (FACIT-Fatigue)(Baseline, Post-intervention (8 weeks))
研究者
Mohamed Salah Saleh
Assistant lecturer at faculty of physical therapy HUE
Cairo University