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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00973258
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : September 17, 2014
National University, Singapore
Alexandra Hospital
St Luke's Hospital, Singapore
Information provided by (Responsible Party):
Ng Tze Pin, National University, Singapore

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.

Condition or disease Intervention/treatment Phase
Pre-Frail or Frail State Dietary Supplement: Nutritional Intervention Other: Physical Exercise Other: Cognitive Training Other: Combined Other: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly
Study Start Date : December 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nutritional Intervention
Nutritional intervention
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 Names:
  • Fortisip
  • Sangobion
  • Neuroforte
  • Caltrate

Experimental: Physical Exercise
Physical exercise training intervention
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 Names:
  • Resistance exercise
  • In-balance exercise

Experimental: Cognitive Training
Cognitive training intervention
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 Names:
  • Reasoning training
  • Memory training
  • Speed training

Experimental: Combined
Nutritional Intervention + Physical Exercise + Cognitive Training
Other: Combined
Nutritional Intervention + Physical Exercise + Cognitive Training

Placebo Comparator: Control Group
Participants will receive their usual diet and placeboes.
Other: Placebo
Participants will receive their usual diet and placeboes.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00973258

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Alexandra Hospital, Singapore
Singapore, Singapore
Sponsors and Collaborators
National Medical Research Council (NMRC), Singapore
National University, Singapore
Alexandra Hospital
St Luke's Hospital, Singapore
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Principal Investigator: Tze-Pin Ng, MD National University, Singapore
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ng Tze Pin, Associated professorial fellow, National University, Singapore Identifier: NCT00973258    
Other Study ID Numbers: NMRC/1108/2007
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014