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

This study has been completed.
Sponsor:
Collaborators:
National University, Singapore
Alexandra Hospital, Singapore
St Luke's Hospital, Singapore
Information provided by (Responsible Party):
Ng Tze Pin, National University, Singapore
ClinicalTrials.gov Identifier:
NCT00973258
First received: September 8, 2009
Last updated: September 15, 2014
Last verified: September 2014

September 8, 2009
September 15, 2014
December 2009
April 2014   (final data collection date for primary outcome measure)
  • Reduction of frailty [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Frailty score (continuous variable) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Frequency of falls [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00973258 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Disability in activities of daily living (ADL) and instrumental activities of daily living (IADL). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly
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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pre-Frail or Frail State
  • 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
  • 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
  • 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
  • Other: Combined
    Nutritional Intervention + Physical Exercise + Cognitive Training
  • Other: Placebo
    Participants will receive their usual diet and placeboes.
  • Experimental: Nutritional Intervention
    Nutritional intervention
    Intervention: Dietary Supplement: Nutritional Intervention
  • Experimental: Physical Exercise
    Physical exercise training intervention
    Intervention: Other: Physical Exercise
  • Experimental: Cognitive Training
    Cognitive training intervention
    Intervention: Other: Cognitive Training
  • Experimental: Combined
    Nutritional Intervention + Physical Exercise + Cognitive Training
    Intervention: Other: Combined
  • Placebo Comparator: Control Group
    Participants will receive their usual diet and placeboes.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
65 Years to 89 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00973258
NMRC/1108/2007
Yes
Ng Tze Pin, National University, Singapore
National Medical Research Council (NMRC), Singapore
  • National University, Singapore
  • Alexandra Hospital, Singapore
  • St Luke's Hospital, Singapore
Principal Investigator: Tze-Pin Ng, MD National University, Singapore
National Medical Research Council (NMRC), Singapore
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP