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: April 22, 2014
Last verified: April 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by National Medical Research Council (NMRC), Singapore:

Primary Outcome Measures:
  • 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 ]
  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: January 2008
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   65 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973258

Locations
Singapore
Alexandra Hospital, Singapore
Singapore, Singapore
Sponsors and Collaborators
National Medical Research Council (NMRC), Singapore
National University, Singapore
Alexandra Hospital, Singapore
St Luke's Hospital, Singapore
Investigators
Principal Investigator: Tze-Pin Ng, MD National University, Singapore
  More Information

No publications provided

Responsible Party: Ng Tze Pin, Associated professorial fellow, National University, Singapore
ClinicalTrials.gov Identifier: NCT00973258     History of Changes
Other Study ID Numbers: NMRC/1108/2007
Study First Received: September 8, 2009
Last Updated: April 22, 2014
Health Authority: Singapore: Domain Specific Review Boards

ClinicalTrials.gov processed this record on July 31, 2014