Treadmill Aerobic Training and Quality of Life in Anemic Females (ATT-QoL-IDA)
11 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Damietta Governorate
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New Damietta, Damietta Governorate, Egito, 34517
- Outpatient Clinics, Faculty of Physical Therapy, Horus University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Physical Fitness Index (PFI)
Prazo: 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)
Prazo: 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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Estimated Maximal Oxygen Consumption (VO2max)
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Nesreen Gharib Elnahas, Prof. Dr., Cairo University
- Diretor de estudo: Farag A. Ali, Prof. Dr., Cairo University
- Diretor de estudo: Asmaa Mohammed Sharabash, Assistant Professor, Cairo University
- Investigador principal: Mohamed Salah Saleh, M.Sc., Cairo University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de novembro de 2025
Conclusão Primária (Real)
15 de janeiro de 2026
Conclusão do estudo (Real)
15 de janeiro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
11 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de junho de 2026
Primeira postagem (Real)
16 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P.T.REC/012/006070
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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