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| Name | Class |
|---|---|
| National University of Singapore | OTHER |
| Alexandra Hospital | OTHER |
| St Luke's Hospital, Singapore | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Intervention | Experimental | Nutritional intervention |
|
| Physical Exercise | Experimental | Physical exercise training intervention |
|
| Cognitive Training | Experimental | Cognitive training intervention |
|
| Combined | Experimental | Nutritional Intervention + Physical Exercise + Cognitive Training |
|
| Control Group | Placebo Comparator | Participants will receive their usual diet and placeboes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Intervention | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of frailty | 12 months | |
| Frailty score (continuous variable) | 12 months | |
| Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months | |
| Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Tze-Pin Ng, MD | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandra Hospital, Singapore | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26159634 | Derived | Ng TP, Feng L, Nyunt MS, Feng L, Niti M, Tan BY, Chan G, Khoo SA, Chan SM, Yap P, Yap KB. Nutritional, Physical, Cognitive, and Combination Interventions and Frailty Reversal Among Older Adults: A Randomized Controlled Trial. Am J Med. 2015 Nov;128(11):1225-1236.e1. doi: 10.1016/j.amjmed.2015.06.017. Epub 2015 Jul 6. |
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|
| Physical Exercise | Other | 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. |
|
|
| Cognitive Training | Other | The proposed cognitive training intervention program comprises:
|
|
|
| Combined | Other | Nutritional Intervention + Physical Exercise + Cognitive Training |
|
| Placebo | Other | Participants will receive their usual diet and placeboes. |
|
| 12 months |
| Mortality | 12 months |
| Disability in activities of daily living (ADL) and instrumental activities of daily living (IADL). | 12 months |
| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| D015444 | Exercise |
| D055070 | Resistance Training |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D000066530 | Neurological Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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