Pre-Frail or Frail StatePhase 3FITNCT00973258
Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly
A Phase 3 study testing Nutritional Intervention, Physical Exercise and Cognitive Training in people with Pre-Frail or Frail State, run by National Medical Research Council (NMRC), Singapore at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-Frail or Frail State
- What is being tested?
- Nutritional Intervention, Physical Exercise and Cognitive Training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2009to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Nutritional Intervention, Physical Exercise, Cognitive Training, Combined, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionDietary supplement
Also called Fortisip, Sangobion, Neuroforte, Caltrate
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 ExerciseOther
Also called Resistance exercise, In-balance 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 TrainingOther
Also called Reasoning training, Memory training, Speed 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.
CombinedOther
Nutritional Intervention + Physical Exercise + Cognitive Training
PlaceboOther
Participants will receive their usual diet and placeboes.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Intervention | Experimental | Nutritional intervention Receives: Dietary Supplement: Nutritional Intervention |
| Physical Exercise | Experimental | Physical exercise training intervention Receives: Other: Physical Exercise |
| Cognitive Training | Experimental | Cognitive training intervention Receives: Other: Cognitive Training |
| Combined | Experimental | Nutritional Intervention + Physical Exercise + Cognitive Training Receives: Other: Combined |
| Control Group | Placebo comparator | Participants will receive their usual diet and placeboes. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of frailty
Measured: 12 months
Frailty score (continuous variable)
Measured: 12 months
Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day).
Measured: 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).
Measured: 12 months
Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission)
Measured: 12 months
Mortality
Measured: 12 months
Disability in activities of daily living (ADL) and instrumental activities of daily living (IADL).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-Frail or Frail StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Council (NMRC), Singapore
- Sponsor type
- Other government
- Collaborators
- National University of Singapore, Alexandra Hospital, St Luke's Hospital, Singapore
- Responsible party
- Principal investigator, Ng Tze Pin, National University of Singapore
- Investigators
- Tze-Pin Ng, MD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973258
- Sponsor's protocol ID
- NMRC/1108/2007
- Acronym
- FIT
- Status last verified
- Sep 2014
- First submitted
- 8 Sep 2009
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26159634
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly
- ClinicalTrials.gov ID
- NCT00973258
- Acronym / sponsor ID
- FIT / NMRC/1108/2007
- Conditions
- Pre-Frail or Frail State
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- National Medical Research Council (NMRC), SingaporeOther government
- Collaborators
- National University of Singapore, Alexandra Hospital, St Luke's Hospital, Singapore
- Study start
- Dec 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nutritional Intervention | Experimental | Dietary Supplement: Nutritional InterventionNutritional intervention |
| Physical Exercise | Experimental | Other: Physical ExercisePhysical exercise training intervention |
| Cognitive Training | Experimental | Other: Cognitive TrainingCognitive training intervention |
| Combined | Experimental | Other: CombinedNutritional Intervention + Physical Exercise + Cognitive Training |
| Control Group | Placebo comparator | Other: PlaceboParticipants will receive their usual diet and placeboes. |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional InterventionAlso: Fortisip, Sangobion, Neuroforte, CaltrateEach 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. | Dietary supplement | Nutritional Intervention |
| Physical ExerciseAlso: Resistance exercise, In-balance exerciseThe 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 | Physical Exercise |
| Cognitive TrainingAlso: Reasoning training, Memory training, Speed trainingThe 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 | Cognitive Training |
| CombinedNutritional Intervention + Physical Exercise + Cognitive Training | Other | Combined |
| PlaceboParticipants will receive their usual diet and placeboes. | Other | Control Group |
Primary outcome
Reduction of frailty
Time frame: 12 months
Frailty score (continuous variable)
Time frame: 12 months
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
4 secondary outcomes
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
Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission)
Time frame: 12 months
Mortality
Time frame: 12 months
Disability in activities of daily living (ADL) and instrumental activities of daily living (IADL).
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Derived from this study: PubMed 26159634Ng 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tze-Pin Ng, MD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nutritional Intervention, Physical Exercise and Cognitive Training in people with Pre-Frail or Frail State, run by National Medical Research Council (NMRC), Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of frailty (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00973258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.