Impact of intravenous iron injections on musculoskeletal function in older adults

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: The study will recruit two groups of stable patients (although likely with chronic diseases) with established iron deficiency anaemia through Aintree Hospital NHS Trust clinics. Fifty patients aged 60‐85 years will be recruited into each group: 1. Intravenous iron therapy group: This group will receive intravenous iron calculated based on body weight and level of anaemia (hemoglobin concentration), as per the iron therapy's SPC 2. Active Control Group: This group will receive oral ferrous sulphate prescribed by their GP Randmisation: Simple randomisation/parallel assignment/single‐blinded Identified patients with iron deficiency anaemia will receive an invitation to participate in the study together with a Patient Information Sheet clearly explaining different aspects of the research project. Each participant will require to attend the School of Health Sciences' laboratories (Liverpool Hope University) on four different occasions (once before the intervention and three times after receiving the iron therapy) throughout a 3‐year period to complete multiple assessments in relation to basic blood tests and musculoskeletal function and physical performance. In addition to this, participants in the first group will require to attend the Aintree Hospital NHS Trust clinics on one occasion to receive a single‐dose intravenous iron. The study will broadly investigate musculoskeletal function (health) and physical performance by means of muscle quality, muscle mass, muscle strength, muscle activation and fatigue levels, gait quality, muscle physiology (level of oxygen carried into the muscles), and functional questionnaires prior to, during, and after iron therapy. In addition to CONDITION: Iron deficiency anaemia ; Circulatory System ; Iron deficiency anaemia PRIMARY OUTCOME: Muscle Quality Index (MQI) determined based on muscle strength relative to quantity/volume of the muscle mass generating the force. Muscle strength will be measured using various dynamometers designed for upper and lower extremities and muscle volume will be assessed using the Bioimpedance technique at screening, week 4, week 12 and week 24 INCLUSION CRITERIA: 1. Anaemia attributable to iron deficiency 2. Haemoglobin <120 g/L in women, Hb <130 g/L in men 3. Ferritin <=100?ng/mL or <=300?ng/mL if transferrin saturation (TSAT) <=30% 4. Age >=60 to 85 years 5. Ambulatory individuals 6. BMI <=40 kg/m² 7. Written informed consent SECONDARY OUTCOME: ; 1. History & Health Screening measured at screening:; 1.1. Health‐history measured using the Health‐history Questionnaire; 1.2. Resting Heart Rate; 1.3. Blood Pressure (mmHg); 1.4. Height (cm), weight (kg), BMI (kg/m²), Waist Circumference (cm); 1.5. Physical activity measured using the International Physical Activity Questionnaire; 2. Biochemical parameters: Blood count, Serum Iron, Serum Ferritin and Transferrin levels measured using blood test at screening, week 4, week 12 and week 24; 3. Muscular Function Profile including strength Measurements of the key muscle groups essential for daily activities and independence including hand‐grip, shoulder, knee at screening, week 4, week 12 and week 24; 4. Skeletal Muscle Mass measured using Segmental Bio‐Impedance at screening, week 4, week 12 and week 24; 5. Fatigability and Activation Pattern of key lower & upper extremity muscle groups measured using electromyography and gait analysis at screening, week 4, week 12 and week 24; 6. Mitochondrial Function measured using near‐infrared spectroscopy atscreening, week 4, week 12 and week 24; 7. Health‐related Quality of Life: SF‐12 Health Survey, The single‐item ‘Life Satisfaction and Personal Well‐Being’ question at screening, week 4, week 12 and week 24; 8. Anxiety and depression measured using the Hospital Anxiety and Depression Scale at screening, week 4, week 12 and week 24; 9. Mood measured using the Profile of Mood States – Short Form at screening, week 4, week 12 and week 24;
Epistemonikos ID: 2b6405d9fd24c36212f2b010f8c418a7f5c5962b
First added on: Aug 24, 2024