Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly (FIT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Medical Research Council (NMRC), Singapore.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
National Medical Research Council (NMRC), Singapore
Collaborators:
National University, Singapore
Alexandra Hospital, Singapore
St Luke's Hospital, Singapore
Information provided by:
National Medical Research Council (NMRC), Singapore
ClinicalTrials.gov Identifier:
NCT00973258
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Frail Elderly |
Dietary Supplement: Nutritional Intervention Other: Physical Exercise Other: Cognitive Training Other: Combined Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly |
Resource links provided by NLM:
Further study details as provided by National Medical Research Council (NMRC), Singapore:
Primary Outcome Measures:
- Frequency of falls [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nutritional Intervention
Nutritional intervention
|
Dietary Supplement: Nutritional Intervention
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:
|
|
Experimental: Physical Exercise
Physical exercise training intervention
|
Other: Physical Exercise
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:
|
|
Experimental: Cognitive Training
Cognitive training intervention
|
Other: Cognitive Training
The proposed cognitive training intervention program comprises:
Other Names:
|
|
Experimental: Combined
Nutritional Intervention + Physical Exercise + Cognitive Training
|
Other: Combined
Nutritional Intervention + Physical Exercise + Cognitive Training
|
|
Placebo Comparator: Control Group
Participants will receive their usual diet and placeboes.
|
Other: Placebo
Participants will receive their usual diet and placeboes.
|
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
Eligibility| Ages Eligible for Study: | 65 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Age of 65 years or older
- Living at home
- Able to walk without personal assistance and no other physical limitations that can limit participation and adherence, particularly to exercise intervention programme
- Meet criteria for frailty
Operational definition of frailty.
The participants are assessed and classified on the level of frailty by the following measures and criteria:
- Weight loss
- Slowness
- Poor balance and weakness assessed by chair stand test
- Muscle weakness assessed by hand grip and knee extension strength
- Exhaustion, fatigue or low endurance
- Low physical activity
Exclusion Criteria:
- Member of household already enrolled
- Dementia or cognitive impairment, major depression or other psychotic disorders
- Severe audio-visual impairment
- Progressive, degenerative neurologic disease like Parkinsonism, fits/ epilepsy, etc
- Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months
- History of alcohol abuse or any other substance abuse
- Severely affect muscle/joint dysfunction resulting in disability
- Hospital admission in the past 3 months
- Regular physical training or physiotherapy or current participation in a vigorous exercise or weight-training program more than once per week
- Undergoing therapeutic diet incompatible with nutritional supplementation
- In the opinion of research clinician, the intervention is deemed to be potentially hazardous for the subject, such as serious cardiac and pulmonary disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973258
Locations
| Singapore | |
| Alexandra Hospital, Singapore | Recruiting |
| Singapore, Singapore | |
| Contact: Susan Hin-Hiang 65-67724518 | |
| Principal Investigator: Philip Yap, MBBS, MRCP | |
Sponsors and Collaborators
National Medical Research Council (NMRC), Singapore
National University, Singapore
Alexandra Hospital, Singapore
St Luke's Hospital, Singapore
Investigators
| Principal Investigator: | Tze-Pin Ng, MD | National University, Singapore |
More Information
No publications provided
| Responsible Party: | Tze-Pin Ng, National University of Singapore |
| ClinicalTrials.gov Identifier: | NCT00973258 History of Changes |
| Other Study ID Numbers: | NMRC/1108/2007 |
| Study First Received: | September 8, 2009 |
| Last Updated: | September 8, 2009 |
| Health Authority: | Singapore: Domain Specific Review Boards |
ClinicalTrials.gov processed this record on May 19, 2013