Alexandra Hospital, Singapore
Singapore
NCT Number: NCT00973258
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.
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Notify Me65 year–89 year
All sexes
Interventional
Phase 3
Singapore
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Operational definition of frailty.
The participants are assessed and classified on the level of frailty by the following measures and criteria:
Exclusion criteria
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.
Other names: Fortisip, Sangobion, Neuroforte, Caltrate
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.
Other names: Resistance exercise, In-balance exercise
The proposed cognitive training intervention program comprises:
Other names: Reasoning training, Memory training, Speed training
Nutritional Intervention + Physical Exercise + Cognitive Training
Participants will receive their usual diet and placeboes.
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
National Medical Research Council (NMRC), Singapore
Other Gov
Acronym: FIT
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