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

NCT ID: NCT00973258

Last Updated: 2014-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2014-04-30

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.

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

Conditions

Pre-Frail or Frail State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Nutritional Intervention

Nutritional intervention

Group Type: EXPERIMENTAL

Nutritional Intervention

Intervention Type: 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.

Physical Exercise

Physical exercise training intervention

Group Type: EXPERIMENTAL

Physical Exercise

Intervention Type: 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.

Cognitive Training

Cognitive training intervention

Group Type: EXPERIMENTAL

Cognitive Training

Intervention Type: OTHER

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.

Combined

Nutritional Intervention + Physical Exercise + Cognitive Training

Group Type: EXPERIMENTAL

Combined

Intervention Type: OTHER

Nutritional Intervention + Physical Exercise + Cognitive Training

Control Group

Participants will receive their usual diet and placeboes.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will receive their usual diet and placeboes.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: 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.

Intervention Type: OTHER

Combined

Nutritional Intervention + Physical Exercise + Cognitive Training

Intervention Type: OTHER

Placebo

Participants will receive their usual diet and placeboes.

Intervention Type: OTHER

Other Intervention Names

Fortisip; Sangobion; Neuroforte; Caltrate; Resistance exercise; In-balance exercise; Reasoning training; Memory training; Speed training

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Singapore

OTHER

Sponsor Role: collaborator

Alexandra Hospital

OTHER

Sponsor Role: collaborator

St Luke's Hospital, Singapore

OTHER

Sponsor Role: collaborator

National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ng Tze Pin

Associated professorial fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tze-Pin Ng, MD

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Locations

Alexandra Hospital, Singapore

Singapore, , Singapore

Countries

Singapore

References

Ng TP, Feng L, Nyunt MS, Feng L, Niti M, Tan BY, Chan G, Khoo SA, Chan SM, Yap P, Yap KB. Nutritional, Physical, Cognitive, and Combination Interventions and Frailty Reversal Among Older Adults: A Randomized Controlled Trial. Am J Med. 2015 Nov;128(11):1225-1236.e1. doi: 10.1016/j.amjmed.2015.06.017. Epub 2015 Jul 6.

Reference Type: DERIVED

PMID: 26159634 (View on PubMed)

Other Identifiers

NMRC/1108/2007

Identifier Type: -

Identifier Source: org_study_id