Pre-Frail or Frail State Clinical Trial
Official title:
Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly
The aims of this proposed community-based randomized controlled trial are to evaluate the effectiveness of nutritional, physical exercise and cognitive training interventions for at-risk and frail elderly, to elucidate the biological determinants and changes associated with frailty, and to develop, evaluate and demonstrate the feasibility of screening instruments for frailty.
Community-living elderly persons are screened and 250 participants satisfying rigorous
criteria for frailty are randomized to received nutritional, physical training, cognitive
training, combined or control arms for 24 weeks and followed up for 12 months. Baseline
evaluations will include an extensive range of potential markers of frailty and outcome
measures, including functional disability and hospitalizations.
Frail subjects who were selected for the interventional trial (N=250) are followed up at 3,
6 and 12 months after baseline assessment. Non-trial subjects (about 2750) are followed up
at 1 year after baseline assessment
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention