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Treadmill Aerobic Training and Quality of Life in Anemic Females (ATT-QoL-IDA)

11. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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:

  1. 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).
  2. 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
    • Damietta Governorate
      • New Damietta, Damietta Governorate, Egypten, 34517
        • Outpatient Clinics, Faculty of Physical Therapy, Horus University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Treadmill Aerobic Exercise
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.
Andet: Standard Medical Care and Nutritional Protocol
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.
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.
Andet: Standard Medical Care and Nutritional Protocol
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical Fitness Index (PFI)
Tidsramme: 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.
Baseline, Post-intervention (8 weeks)
Health-Related Quality of Life (HRQoL) - SF-12 Physical Component Summary (PCS)
Tidsramme: 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).
Baseline, Post-intervention (8 weeks)
Health-Related Quality of Life (HRQoL) - SF-12 Mental Component Summary (MCS)
Tidsramme: 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).
Baseline, Post-intervention (8 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimated Maximal Oxygen Consumption (VO2max)
Tidsramme: Baseline, Post-intervention (8 weeks)
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)
Fatigue Severity (FACIT-Fatigue)
Tidsramme: Baseline, Post-intervention (8 weeks)
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Samarbejdspartnere

Horus University

Efterforskere

  • Studiestol: Nesreen Gharib Elnahas, Prof. Dr., Cairo University
  • Studieleder: Farag A. Ali, Prof. Dr., Cairo University
  • Studieleder: Asmaa Mohammed Sharabash, Assistant Professor, Cairo University
  • Ledende efterforsker: Mohamed Salah Saleh, M.Sc., Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. november 2025

Primær færdiggørelse (Faktiske)

15. januar 2026

Studieafslutning (Faktiske)

15. januar 2026

Datoer for studieregistrering

Først indsendt

11. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P.T.REC/012/006070

Plan for individuelle deltagerdata (IPD)

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