Skip to main content
OpenTrials
Completed

NCT Number: NCT00973258

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alexandra Hospital, Singapore

Singapore

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional intervention

Dietary Supplement

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: Fortisip, Sangobion, Neuroforte, Caltrate

Physical exercise

Other

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: Resistance exercise, In-balance exercise

Cognitive Training

Other

The proposed cognitive training intervention program comprises:

  • Reasoning training focusing on inductive reasoning, the ability to solve problems that follow a serial pattern and manifest in executive functioning.
  • Memory training focusing on verbal episodic memory, which deals with acquisition and retrieval of information acquired in a particular place at a particular time.
  • 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 names: Reasoning training, Memory training, Speed training

Combined

Other

Nutritional Intervention + Physical Exercise + Cognitive Training

Placebo

Other

Participants will receive their usual diet and placeboes.

Primary outcomes

  1. Reduction of frailty

    Time frame: 12 months

  2. Frailty score (continuous variable)

    Time frame: 12 months

  3. 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

Secondary outcomes

  1. 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).

    Time frame: 12 months

  2. Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission)

    Time frame: 12 months

  3. Mortality

    Time frame: 12 months

  4. Disability in activities of daily living (ADL) and instrumental activities of daily living (IADL).

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

National Medical Research Council (NMRC), Singapore

Other Gov

Collaborators

  • Alexandra Hospital
  • National University of Singapore
  • St Luke's Hospital, Singapore

Registry information

Acronym: FIT

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2009
Registry last updated
Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.