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

Pre-Frail or Frail State Clinical Trial

— FIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973258
• Other study ID #: NMRC/1108/2007
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2009
• Last updated: September 15, 2014
• Start date: December 2009
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: National Medical Research Council (NMRC), Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 89 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Frail or Frail State

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:
• 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.
• Cognitive Training
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.
• Combined
Nutritional Intervention + Physical Exercise + Cognitive Training
• Placebo
Participants will receive their usual diet and placeboes.

Locations

Country	Name	City	State
Singapore	Alexandra Hospital, Singapore	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
National Medical Research Council (NMRC), Singapore	Alexandra Hospital, Singapore, National University, Singapore, St Luke's Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of frailty		12 months	No
Primary	Frailty score (continuous variable)		12 months	No
Primary	Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day).		12 months	No
Secondary	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).		12 months	No
Secondary	Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission)		12 months	No
Secondary	Mortality		12 months	No
Secondary	Disability in activities of daily living (ADL) and instrumental activities of daily living (IADL).		12 months	No