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

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.

Conditions

• Pre-Frail or Frail State

Interventions

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

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

Cognitive Training

The proposed cognitive training intervention program comprises: 1. Reasoning training focusing on inductive reasoning, the ability to solve problems that follow a serial pattern and manifest in executive functioning. 2. Memory training focusing on verbal episodic memory, which deals with acquisition and retrieval of information acquired in a particular place at a particular time. 3. Speed training focusing on visual search and the ability to identify and locate visual information quickly in a divided attention format, with and without distractors.

OTHER

Combined

Nutritional Intervention + Physical Exercise + Cognitive Training

OTHER

Placebo

Participants will receive their usual diet and placeboes.

Sponsors & Collaborators

• National University of Singapore

  collaborator OTHER

• Alexandra Hospital

  collaborator OTHER

• St Luke's Hospital, Singapore

  collaborator OTHER

• National Medical Research Council (NMRC), Singapore

  lead OTHER_GOV

Principal Investigators

• Tze-Pin Ng, MD · National University of Singapore

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2014-04-30

Completion

2014-04-30

Countries

• Singapore

Study Locations