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| Name | Class |
|---|---|
| Horus University | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Training Group (Group A) | Experimental | 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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| Control Group (Group B) | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treadmill Aerobic Exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Fitness Index (PFI) | 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. | Baseline, Post-intervention (8 weeks) |
| Health-Related Quality of Life (HRQoL) - SF-12 Physical Component Summary (PCS) | 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). | Baseline, Post-intervention (8 weeks) |
| Health-Related Quality of Life (HRQoL) - SF-12 Mental Component Summary (MCS) | 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). | Baseline, Post-intervention (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Maximal Oxygen Consumption (VO2max) | 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. | Baseline, Post-intervention (8 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nesreen Gharib Elnahas, Prof. Dr. | Cairo University | Study Chair |
| Farag A. Ali, Prof. Dr. | Cairo University | Study Director |
| Asmaa Mohammed Sharabash, Assistant Professor | Cairo University | Study Director |
| Mohamed Salah Saleh, M.Sc. | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Clinics, Faculty of Physical Therapy, Horus University | New Damietta | Damietta Governorate | 34517 | Egypt |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Standard Medical Care and Nutritional Protocol | Other | 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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| Fatigue Severity (FACIT-Fatigue) | 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. | Baseline, Post-intervention (8 weeks) |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |