A Phase 3 interventional study of Nutritional Intervention and Physical Exercise in Pre-Frail or Frail State, sponsored by National Medical Research Council (NMRC), Singapore. Completed at 1 site in Singapore. Open to participants aged 65 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-17.
Sponsored by National Medical Research Council (NMRC), Singapore · Phase 3, Interventional, and Prevention
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
Operational definition of frailty.
The participants are assessed and classified on the level of frailty by the following measures and criteria:
Exclusion Criteria:
Nutritional intervention
Dietary Supplement: Nutritional Intervention
Physical exercise training intervention
Other: Physical Exercise
Cognitive training intervention
Other: Cognitive Training
Nutritional Intervention + Physical Exercise + Cognitive Training
Other: Combined
Participants will receive their usual diet and placeboes.
Other: Placebo
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.
Also known as: 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.
Also known as: Resistance exercise, In-balance exercise
The proposed cognitive training intervention program comprises: 1. Reasoning training focusing on inductive reasoning, the ability to solve problems that follow a serial pattern and manifest in executive functioning. 2. Memory training focusing on verbal episodic memory, which deals with acquisition and retrieval of information acquired in a particular place at a particular time. 3. 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.
Also known as: Reasoning training, Memory training, Speed training
Nutritional Intervention + Physical Exercise + Cognitive Training
Participants will receive their usual diet and placeboes.
Reduction of frailty
Time frame: 12 months
Frailty score (continuous variable)
Time frame: 12 months
Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day).
Time frame: 12 months
Frequency of falls (defined as an event resulting in a person coming to rest unintentionally on the ground or other lower level; near-falls are not included; Robertson, 2001).
Time frame: 12 months
Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission)
Time frame: 12 months
Mortality
Time frame: 12 months
Disability in activities of daily living (ADL) and instrumental activities of daily living (IADL).
Time frame: 12 months
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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National Medical Research Council (NMRC), Singapore