Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly
Condition: Pre-Frail or Frail State
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Nutritional Intervention; Physical Exercise; Cognitive Training; Combined; Placebo
Intervention type(s): Dietary Supplement; Other; Other; Other; Other
Intervention description(s): Each subject in the nutritional intervention group is provided with a commercial liquid formula (Fortisip Multi Fibre, Nutricia), which should be taken every evening for a period of 24 weeks. Subjects are also given one capsule of iron and folate supplement (Sangobion, Merck; consisting of 1 mg folate and 29mg iron), one capsule of Vitamin B6 and vitamin B12 supplement (Neuroforte; consisting of 200mcg B12 and 200mg vit B6) and one tablet of Caltrate with Vitamin D (consisting of 200 IU vitamin D and 600 mg of calcium) for a duration of 24 weeks.; The exercise intervention group comprises a combination of 2 types of exercise: resistance exercise and in-balance exercise. Key components in both programs are balance and strength, because these are the most prominent domains that should be addressed in at risk frail elderly. The first program is administered in the first 6-week, and then followed by the second program for the next 6-week of intervention period. Both exercise programmes are tailored to the functional needs of the participants, maintaining a moderate intensity that focuses on long-term sustainability and enjoyment.; The proposed cognitive training intervention program comprises:
Reasoning training focusing on inductive reasoning, the ability to solve problems that follow a serial pattern and manifest in executive functioning.
Memory training focusing on verbal episodic memory, which deals with acquisition and retrieval of information acquired in a particular place at a particular time.
Speed training focusing on visual search and the ability to identify and locate visual information quickly in a divided attention format, with and without distractors.; Nutritional Intervention + Physical Exercise + Cognitive Training; Participants will receive their usual diet and placeboes.
Other intervention name(s): Fortisip; Sangobion; Neuroforte; Caltrate; Resistance exercise; In-balance exercise; Reasoning training; Memory training; Speed training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention