Treadmill Aerobic Training and Quality of Life in Anemic Females

NCT07651098 | Completed

• 1 other identifier: P.T.REC/012/006070
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anemia Treatment; Iron Deficiency Anemia (IDA)

Keywords

Treadmill Training; Aerobic Exercise; Quality of Life; Physical Fitness; Anemic Females

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (2)

• Estimated Maximal Oxygen Consumption (VO2max)

  Baseline, Post-intervention (8 weeks)

• Fatigue Severity (FACIT-Fatigue)

  Baseline, Post-intervention (8 weeks)

Study Arms (2)

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.

Behavioral: Treadmill Aerobic Exercise; Other: Standard Medical Care and Nutritional Protocol

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.

Other: Standard Medical Care and Nutritional Protocol

Interventions

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.

Aerobic Training Group (Group A)

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.

Aerobic Training Group (Group A); Control Group (Group B)

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Horus University: collaborator

Study Sites (1)

Outpatient Clinics, Faculty of Physical Therapy, Horus University

New Damietta, Damietta Governorate, 34517, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at faculty of physical therapy HUE

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: November 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)