Treadmill Aerobic Training and Quality of Life in Anemic Females (ATT-QoL-IDA)
11. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Damietta Governorate
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New Damietta, Damietta Governorate, Egypt, 34517
- Outpatient Clinics, Faculty of Physical Therapy, Horus University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Physical Fitness Index (PFI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Estimated Maximal Oxygen Consumption (VO2max)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Nesreen Gharib Elnahas, Prof. Dr., Cairo University
- Studieleder: Farag A. Ali, Prof. Dr., Cairo University
- Studieleder: Asmaa Mohammed Sharabash, Assistant Professor, Cairo University
- Hovedetterforsker: Mohamed Salah Saleh, M.Sc., Cairo University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. november 2025
Primær fullføring (Faktiske)
15. januar 2026
Studiet fullført (Faktiske)
15. januar 2026
Datoer for studieregistrering
Først innsendt
11. juni 2026
Først innsendt som oppfylte QC-kriteriene
11. juni 2026
Først lagt ut (Faktiske)
16. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P.T.REC/012/006070
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