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

NCT00973258 | Completed Phase 3 DMC

• 1 other identifier: NMRC/1108/2007
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Frail or Frail State

Outcome Measures

Primary Outcomes (3)

• Reduction of frailty

  12 months

• Frailty score (continuous variable)

  12 months

• Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day).

  12 months

Secondary Outcomes (4)

• 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

• Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission)

  12 months

• Mortality

  12 months

• Disability in activities of daily living (ADL) and instrumental activities of daily living (IADL).

  12 months

Study Arms (5)

Nutritional Intervention

EXPERIMENTAL

Nutritional intervention

Dietary Supplement: Nutritional Intervention

Physical Exercise

EXPERIMENTAL

Physical exercise training intervention

Other: Physical Exercise

Cognitive Training

EXPERIMENTAL

Cognitive training intervention

Other: Cognitive Training

Combined

EXPERIMENTAL

Nutritional Intervention + Physical Exercise + Cognitive Training

Other: Combined

Control Group

PLACEBO COMPARATOR

Participants will receive their usual diet and placeboes.

Other: Placebo

Interventions

Nutritional Intervention 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.

Also known as: Fortisip, Sangobion, Neuroforte, Caltrate

Nutritional Intervention

Physical Exercise 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.

Also known as: Resistance exercise, In-balance exercise

Physical Exercise

Cognitive Training 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.

Also known as: Reasoning training, Memory training, Speed training

Cognitive Training

Combined OTHER

Nutritional Intervention + Physical Exercise + Cognitive Training

Combined

Placebo OTHER

Participants will receive their usual diet and placeboes.

Control Group

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age of 65 years or older
• Living at home
• Able to walk without personal assistance and no other physical limitations that can limit participation and adherence, particularly to exercise intervention programme
• 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:
• Weight loss
• Slowness
• Poor balance and weakness assessed by chair stand test
• Muscle weakness assessed by hand grip and knee extension strength
• Exhaustion, fatigue or low endurance
• Low physical activity

You may not qualify if:

• Member of household already enrolled
• Dementia or cognitive impairment, major depression or other psychotic disorders
• Severe audio-visual impairment
• Progressive, degenerative neurologic disease like Parkinsonism, fits/ epilepsy, etc
• Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months
• History of alcohol abuse or any other substance abuse
• Severely affect muscle/joint dysfunction resulting in disability
• Hospital admission in the past 3 months
• Regular physical training or physiotherapy or current participation in a vigorous exercise or weight-training program more than once per week
• Undergoing therapeutic diet incompatible with nutritional supplementation
• In the opinion of research clinician, the intervention is deemed to be potentially hazardous for the subject, such as serious cardiac and pulmonary disease.

Sponsors & Collaborators

• National Medical Research Council (NMRC), Singapore: lead
• National University of Singapore: collaborator
• Alexandra Hospital: collaborator
• St Luke's Hospital, Singapore: collaborator

Study Sites (1)

Alexandra Hospital, Singapore

Singapore, Singapore

Location

Related Publications (1)

• 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.

  PMID: 26159634 DERIVED

MeSH Terms

Interventions

Calcium Carbonate; Exercise; Resistance Training; Cognitive Training

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Neurological Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Tze-Pin Ng, MD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professorial fellow

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: December 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

SG (1)