Status:
COMPLETED
Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly
Lead Sponsor:
National Medical Research Council (NMRC), Singapore
Collaborating Sponsors:
National University of Singapore
Alexandra Hospital
Conditions:
Pre-Frail or Frail State
Eligibility:
All Genders
65-89 years
Phase:
PHASE3
Brief 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 eld...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00973258
Start Date
December 1 2009
End Date
April 1 2014
Last Update
September 17 2014
Active Locations (1)
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1
Alexandra Hospital, Singapore
Singapore, Singapore