Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly (FIT)

National Medical Research Council (NMRC), Singapore

Status and phase: Completed; Phase 3

Conditions: Pre-Frail or Frail State

Treatments: Other: Combined; Other: Placebo; Other: Cognitive Training; Dietary Supplement: Nutritional Intervention; Other: Physical Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00973258

NMRC/1108/2007

Details and patient eligibility

About

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.

Full 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

Enrollment: 246 patients

Sex: All

Ages: 65 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age of 65 years or older
2. Living at home
3. Able to walk without personal assistance and no other physical limitations that can limit participation and adherence, particularly to exercise intervention programme
4. 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:

1. Weight loss
2. Slowness
3. Poor balance and weakness assessed by chair stand test
4. Muscle weakness assessed by hand grip and knee extension strength
5. Exhaustion, fatigue or low endurance
6. Low physical activity

Exclusion criteria

1. Member of household already enrolled
2. Dementia or cognitive impairment, major depression or other psychotic disorders
3. Severe audio-visual impairment
4. Progressive, degenerative neurologic disease like Parkinsonism, fits/ epilepsy, etc
5. Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months
6. History of alcohol abuse or any other substance abuse
7. Severely affect muscle/joint dysfunction resulting in disability
8. Hospital admission in the past 3 months
9. Regular physical training or physiotherapy or current participation in a vigorous exercise or weight-training program more than once per week
10. Undergoing therapeutic diet incompatible with nutritional supplementation
11. In the opinion of research clinician, the intervention is deemed to be potentially hazardous for the subject, such as serious cardiac and pulmonary disease.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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246 participants in 5 patient groups, including a placebo group

Nutritional Intervention

Experimental group

Description:

Nutritional intervention

Treatment:

Dietary Supplement: Nutritional Intervention

Physical Exercise

Experimental group

Description:

Physical exercise training intervention

Treatment:

Other: Physical Exercise

Cognitive Training

Experimental group

Description:

Cognitive training intervention

Treatment:

Other: Cognitive Training

Combined

Experimental group

Description:

Nutritional Intervention + Physical Exercise + Cognitive Training

Treatment:

Other: Combined

Control Group

Placebo Comparator group

Description:

Participants will receive their usual diet and placeboes.

Treatment:

Other: Placebo