Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pre-Frail or Frail State
- Sponsor
- National Medical Research Council (NMRC), Singapore
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- Frailty score (continuous variable)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 elderly, to elucidate the biological determinants and changes associated with frailty, and to develop, evaluate and demonstrate the feasibility of screening instruments for frailty.
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
Investigators
Ng Tze Pin
Associated professorial fellow
National University of Singapore
Eligibility 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
- •Poor balance and weakness assessed by chair stand test
- •Muscle weakness assessed by hand grip and knee extension strength
- •Exhaustion, fatigue or low endurance
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
Outcomes
Primary Outcomes
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
Reduction of frailty
Time Frame: 12 months
Secondary Outcomes
- Mortality(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).(12 months)
- Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission)(12 months)
- Disability in activities of daily living (ADL) and instrumental activities of daily living (IADL).(12 months)