NCT04600453.
Study name | Prevention of functional and cognitive impairment through a multicomponent exercise program in hospitalized elderly |
Methods |
Design: randomised controlled trial Baseline time point (T1): admission to hospital Outcome time point (T2): discharge from hospital Follow‐up time point (T3): 3 years after hospital discharge |
Participants |
Inclusion criteria: aged > 75 years; Barthel Index ≥ 60 points; able to ambulate (with/without assistance); provide informed consent; able to communicate Exclusion criteria: expected length of stay < 6 days; terminal illness; very severe cognitive decline (i.e. Global Deterioration Scale 7); uncontrolled arrhythmias, acute pulmonary embolism and myocardial infarction, or extremity bone fracture in the past 3 months Target sample size: 240 |
Interventions |
Exercise arm: multicomponent exercise training programme composed of supervised progressive resistance exercise training, balance‐training and walking for 4 consecutive days. During the training period, participants will be trained in 20‐minute sessions twice per day (morning and evening). The supervised multicomponent exercise training programme will comprise upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2–3 sets of 8–10 repetitions at an intensity of 40–60% of 1 repetition maximum combined with balance and gait retraining exercises that progressed in difficulty and functional exercises, such as rises from a chair. The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital Control arm: usual care for setting |
Outcomes | Short Physical Performance Battery EuroQol‐5 Dimension (EQ‐5D) visual analogue scale Incidence of delirium as assessed with the Confusion Assessment Method 3‐year mortality Total use of health‐related resources (number of readmissions, visits to accident and emergency department, visits to outpatient clinics) |
Starting date | October 2020 |
Contact information | Nicolas Martinez Velilla nicolas.martinez.velilla@cfnavarra.es |
Notes | clinicaltrials.gov/ct2/show/NCT04600453 |
ADL: activities of daily living.