Frail ElderlyFPINPSNCT03477097
Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation
A study testing Nutrition, exercise and social network intervention in people with Frail Elderly, run by Academia Sinica, Taiwan at 1 site in Taiwan.
Trial summary
The life expectancy of the Taiwanese reached 75.98 years in males and 82.65 years in females in 2011. Because of the improved longevity and low birth rate, proportion of elderly population increased to 11.15% in our society. It is expected to be 21.2% in 2016. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Nutrition, exercise and social network intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2015to Jun 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- To walk 14 meters within 1 minute by him-/ her-self
- Fried score is in the range of 1 to 5 points
- To be willing to join 3-month intervention
Who cannot join
- Having sever disease (i.e., cancer, under intensive care, or survival time < 6 months)
- Having communication problem (i.e., hearing-impaired, visually disabled, aphasia, dementia, or schizophrenia)
- Stay in the nursing home or other similar institutes
- Having joined other study
- Not willing to take the food supplement of multiple vitamin, fruit/vegetable concentrate capsule, and fish oil
- GDS > = 10 points or MMSE < 24 (If he/ she is illiteracy, MMSE < 17)
Trial locations and contacts
1 site in 1 country.
About this study
The life expectancy of the Taiwanese reached 75.98 years in males and 82.65 years in females in 2011. Because of the improved longevity and low birth rate, proportion of elderly population increased to 11.15% in our society. It is expected to be 21.2% in 2016. Frailty syndrome is an important path to disability or mortality in the elderly. Increase on disability will become a great burden to the society. This trend of population aging phenomenon occurs worldwide.
Frailty syndrome was defined by Fried el al. as older adults meet 3 of the following 5 conditions: (1) unintentional weight loss over 10 lbs in previous year, (2) weakness (grip strength at the lowest 20% by gender and BMI), (3) exhaustion (self-reported), (4) slowness (at the lowest 20% by gender and height), and (5) low physical activity. However, the definition of frailty is under discussion worldwide.
Read more
The sociological significance of frailty is that elders facing their changing roles in the society due to the changing position within the societal structure (i.e. moving from playing nuclear roles to marginal roles involuntarily or voluntarily) may potentially experience decline in psychosocial and physical well beings. Psychosocial and lifestyle factors and biomarkers are not well studied with respect to frailty. It is crucial to understand the social and biological risk factors of frailty and to design and study the possible prevention strategy for the prevention and management of frailty.
Therefore, the investigators propose to use randomization trials to investigate (1) the developmental process of frailty, the psycho-social determinants, related biomarkers and lifestyle factors; (2) the non-pharmaceutical intervention on preventing the progression of frailty and the cost-benefit of the intervention.
The investigators expect to (1) identify social determinants, biological and lifestyle factors which are associated with the development of frailty; (2) design and test clinical strategies to prevent frailty progression and (3) estimate the cost-effectiveness of the intervention. The results will have implications in public health education and in health policy making in order to prevent and to manage frailty in the elderly.
Read the detailed description
This trial was conducted between October 2015 and June 2017 at the Miaoli General Hospital in Taiwan, and all eligible participants signed informed consent. The eligible pre-frail or frail elderly were screened according to the frailty phenotypes proposed by Fried and colleagues in the outpatient clinics. Participants who were over 65 years old and were able to walk 14 m independently were eligible for recruitment. The main exclusion criteria were critical illnesses; impairment in communication; nursing-home residents; participating other studies or taking nutritional supplementation; severe depression (Geriatric Depression Scale (GDS) < 10 points) or cognitive impairment (Mini Mental State Examination < 23 points). Participants were randomly assigned into study groups for 3-month intervention and 3-month self-maintenance period. The assessment of all participants were conducted by blind case managers at baseline, 1 month, 3 months, and 6 months.
- Conditions
- Frail Elderly
- Being tested
- Nutrition, exercise and social network intervention
- Keywords
- Frailty, Social Determinants, Biological Risk Factors, Intervention, Cost Effectiveness
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition, exercise and social network interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Control group w/o social network intervention | No intervention | Subjects did not receive any intervention of nutrition, physical activity and social network. |
| Control group w/ social network intervention | Experimental | Subjects only received the intervention of social network. Receives: Other: Nutrition, exercise and social network intervention |
| Nutrition group 1 w/o social network intervention | Experimental | Subjects only received the nutrition I intervention (e.g., food plate and multiple vitamin/ minerals powder). Receives: Other: Nutrition, exercise and social network intervention |
| Nutrition group 1 w/ social network intervention | Experimental | Subjects received the nutrition I intervention (e.g., food plate and multiple vitamin/ minerals powder) and social network intervention as well. Receives: Other: Nutrition, exercise and social network intervention |
| Nutrition group 2 w/o social network intervention | Experimental | Subjects only received the nutrition II intervention (e.g., food plate, multiple vitamin/ minerals powder, fruit/vegetable concentrate capsule, and fish oil). Receives: Other: Nutrition, exercise and social network intervention |
| Nutrition group 2 w/ social network intervention | Experimental | Subjects received the nutrition II intervention (e.g., food plate, multiple vitamin/ minerals powder, fruit/vegetable concentrate capsule, and fish oil) and social network intervention as well. Receives: Other: Nutrition, exercise and social network intervention |
| Physical activity group w/o social network intervention | Experimental | Subjects only received the personalized homed-based exercise prescription, which consisted of a combination of strength, flexibility, balance and endurance training. Receives: Other: Nutrition, exercise and social network intervention |
| Physical activity group w/ social network intervention | Experimental | Subjects received the personalized homed-based exercise prescription, which consisted of a combination of strength, flexibility, balance and endurance training, and social network intervention as well. Receives: Other: Nutrition, exercise and social network intervention |
| Nutrition 1 + physical activity group w/o social network | Experimental | Subjects received the nutrition I (e.g., food plate and multiple vitamin/ minerals powder) and exercise (e.g., personalized homed-based exercise plan) intervention. Receives: Other: Nutrition, exercise and social network intervention |
| Nutrition 1 + physical activity group w/ social network | Experimental | Subjects received the nutrition I (e.g., food plate and multiple vitamin/ minerals powder), exercise (e.g., personalized homed-based exercise plan), and social network intervention. Receives: Other: Nutrition, exercise and social network intervention |
| Nutrition 2 + physical activity group w/o social network | Experimental | Subjects only received the nutrition II (e.g., food plate, multiple vitamin/ minerals powder, fruit/vegetable concentrate capsule, and fish oil) and exercise (e.g., personalized homed-based exercise plan) intervention. Receives: Other: Nutrition, exercise and social network intervention |
| Nutrition 2 + physical activity group w/ social network | Experimental | Subjects only received the nutrition II (e.g., food plate, multiple vitamin/ minerals powder, fruit/vegetable concentrate capsule, and fish oil), exercise (e.g., personalized homed-based exercise plan), and social network intervention. Receives: Other: Nutrition, exercise and social network intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty score (Score range: 0-5, higher scores indicate worse performance)
Based on the Cardiovascular Health Study criteria, the frailty phenotypes were quantified by frailty score, which was the primary outcome in this study.
Measured: 6 months
Secondary outcomes (8)
Handgrip strength
Physical performance measure
Measured: 6 months
Gait speed
Physical performance measure
Measured: 6 months
Back scratch
Physical performance measure
Measured: 6 months
Sit and reach
Physical performance measure
Measured: 6 months
Standing heel-rise
Physical performance measure
Measured: 6 months
Geriatric Depression Scale (Score range: 0-15, higher scores indicate worse performance)
Mental Health measure
Measured: 6 months
Mini Mental State Examination (Score range: 0-30, higher scores indicate better performance)
Mental Health measure
Measured: 6 months
Short form-12 mental component summary score (Score range: 0-100, higher scores indicate better performance)
Mental Health measure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study startOct 2015
- Primary completionJun 2017
- Study completionJun 2017
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 Frail ElderlyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academia Sinica, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, Miaoli General Hospital, Ministry of Health and Welfare, Taiwan
- Responsible party
- Principal investigator, Wen-Harn Pan, Academia Sinica, Taiwan
- Investigators
- Wen-Harn Pan, Ph.D., Principal investigator, Institute of Biomedical Sciences, Academia Sinica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477097
- Sponsor's protocol ID
- AS-IRB-BM-15020
- Acronym
- FPINPS
- Status last verified
- Mar 2018
- First submitted
- 11 Jan 2016
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsieh TJ, Su SC, Chen CW, Kang YW, Hu MH, Hsu LL, Wu SY, Chen L, Chang HY, Chuang SY, Pan WH, Hsu CC. Individualized home-based exercise and nutrition interventions improve frailty in older adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2019 Dec 2;16(1):119. doi: 10.1186/s12966-019-0855-9.
PubMed 31791364
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation
- ClinicalTrials.gov ID
- NCT03477097
- Acronym / sponsor ID
- FPINPS / AS-IRB-BM-15020
- Conditions
- Frail Elderly
- Keywords
- Frailty, Social Determinants, Biological Risk Factors, Intervention, Cost Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Academia Sinica, TaiwanUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, Miaoli General Hospital, Ministry of Health and Welfare, Taiwan
- Study start
- Oct 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Mar 2018 (actual)
- 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 life expectancy of the Taiwanese reached 75.98 years in males and 82.65 years in females in 2011. Because of the improved longevity and low birth rate, proportion of elderly population increased to 11.15% in our society. It is expected to be 21.2% in 2016. Frailty syndrome is an important path to disability or mortality in the elderly. Increase on disability will become a great burden to the society. This trend of population aging phenomenon occurs worldwide.
Frailty syndrome was defined by Fried el al. as older adults meet 3 of the following 5 conditions: (1) unintentional weight loss over 10 lbs in previous year, (2) weakness (grip strength at the lowest 20% by gender and BMI), (3) exhaustion (self-reported), (4) slowness (at the lowest 20% by gender and height), and (5) low physical activity. However, the definition of frailty is under discussion worldwide.
The sociological significance of frailty is that elders facing their changing roles in the society due to the changing position within the societal structure (i.e. moving from playing nuclear roles to marginal roles involuntarily or voluntarily) may potentially experience decline in psychosocial and physical well beings. Psychosocial and lifestyle factors and biomarkers are not well studied with respect to frailty. It is crucial to understand the social and biological risk factors of frailty and to design and study the possible prevention strategy for the prevention and management of frailty.
Therefore, the investigators propose to use randomization trials to investigate (1) the developmental process of frailty, the psycho-social determinants, related biomarkers and lifestyle factors; (2) the non-pharmaceutical intervention on preventing the progression of frailty and the cost-benefit of the intervention.
The investigators expect to (1) identify social determinants, biological and lifestyle factors which are associated with the development of frailty; (2) design and test clinical strategies to prevent frailty progression and (3) estimate the cost-effectiveness of the intervention. The results will have implications in public health education and in health policy making in order to prevent and to manage frailty in the elderly.
Detailed description
This trial was conducted between October 2015 and June 2017 at the Miaoli General Hospital in Taiwan, and all eligible participants signed informed consent. The eligible pre-frail or frail elderly were screened according to the frailty phenotypes proposed by Fried and colleagues in the outpatient clinics. Participants who were over 65 years old and were able to walk 14 m independently were eligible for recruitment. The main exclusion criteria were critical illnesses; impairment in communication; nursing-home residents; participating other studies or taking nutritional supplementation; severe depression (Geriatric Depression Scale (GDS) < 10 points) or cognitive impairment (Mini Mental State Examination < 23 points). Participants were randomly assigned into study groups for 3-month intervention and 3-month self-maintenance period. The assessment of all participants were conducted by blind case managers at baseline, 1 month, 3 months, and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Control group w/o social network intervention | No intervention | –Subjects did not receive any intervention of nutrition, physical activity and social network. |
| Control group w/ social network intervention | Experimental | Other: Nutrition, exercise and social network interventionSubjects only received the intervention of social network. |
| Nutrition group 1 w/o social network intervention | Experimental | Other: Nutrition, exercise and social network interventionSubjects only received the nutrition I intervention (e.g., food plate and multiple vitamin/ minerals powder). |
| Nutrition group 1 w/ social network intervention | Experimental | Other: Nutrition, exercise and social network interventionSubjects received the nutrition I intervention (e.g., food plate and multiple vitamin/ minerals powder) and social network intervention as well. |
| Nutrition group 2 w/o social network intervention | Experimental | Other: Nutrition, exercise and social network interventionSubjects only received the nutrition II intervention (e.g., food plate, multiple vitamin/ minerals powder, fruit/vegetable concentrate capsule, and fish oil). |
| Nutrition group 2 w/ social network intervention | Experimental | Other: Nutrition, exercise and social network interventionSubjects received the nutrition II intervention (e.g., food plate, multiple vitamin/ minerals powder, fruit/vegetable concentrate capsule, and fish oil) and social network intervention as well. |
| Physical activity group w/o social network intervention | Experimental | Other: Nutrition, exercise and social network interventionSubjects only received the personalized homed-based exercise prescription, which consisted of a combination of strength, flexibility, balance and endurance training. |
| Physical activity group w/ social network intervention | Experimental | Other: Nutrition, exercise and social network interventionSubjects received the personalized homed-based exercise prescription, which consisted of a combination of strength, flexibility, balance and endurance training, and social network intervention as well. |
| Nutrition 1 + physical activity group w/o social network | Experimental | Other: Nutrition, exercise and social network interventionSubjects received the nutrition I (e.g., food plate and multiple vitamin/ minerals powder) and exercise (e.g., personalized homed-based exercise plan) intervention. |
| Nutrition 1 + physical activity group w/ social network | Experimental | Other: Nutrition, exercise and social network interventionSubjects received the nutrition I (e.g., food plate and multiple vitamin/ minerals powder), exercise (e.g., personalized homed-based exercise plan), and social network intervention. |
| Nutrition 2 + physical activity group w/o social network | Experimental | Other: Nutrition, exercise and social network interventionSubjects only received the nutrition II (e.g., food plate, multiple vitamin/ minerals powder, fruit/vegetable concentrate capsule, and fish oil) and exercise (e.g., personalized homed-based exercise plan) intervention. |
| Nutrition 2 + physical activity group w/ social network | Experimental | Other: Nutrition, exercise and social network interventionSubjects only received the nutrition II (e.g., food plate, multiple vitamin/ minerals powder, fruit/vegetable concentrate capsule, and fish oil), exercise (e.g., personalized homed-based exercise plan), and social network intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- To walk 14 meters within 1 minute by him-/ her-self
- Fried score is in the range of 1 to 5 points
- To be willing to join 3-month intervention
Key exclusion criteria (6 listed)
- Having sever disease (i.e., cancer, under intensive care, or survival time < 6 months)
- Having communication problem (i.e., hearing-impaired, visually disabled, aphasia, dementia, or schizophrenia)
- Stay in the nursing home or other similar institutes
- Having joined other study
- Not willing to take the food supplement of multiple vitamin, fruit/vegetable concentrate capsule, and fish oil
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 |
|---|---|---|
| Nutrition, exercise and social network intervention | Other | Control group w/ social network intervention, Nutrition 1 + physical activity group w/ social network, Nutrition 1 + physical activity group w/o social network, Nutrition 2 + physical activity group w/ social network, Nutrition 2 + physical activity group w/o social network, Nutrition group 1 w/ social network intervention, Nutrition group 1 w/o social network intervention, Nutrition group 2 w/ social network intervention, Nutrition group 2 w/o social network intervention, Physical activity group w/ social network intervention, Physical activity group w/o social network intervention |
Primary outcome
Frailty score (Score range: 0-5, higher scores indicate worse performance)
Time frame: 6 months
Based on the Cardiovascular Health Study criteria, the frailty phenotypes were quantified by frailty score, which was the primary outcome in this study.
8 secondary outcomes
Handgrip strength
Time frame: 6 months
Gait speed
Time frame: 6 months
Back scratch
Time frame: 6 months
Sit and reach
Time frame: 6 months
Standing heel-rise
Time frame: 6 months
Geriatric Depression Scale (Score range: 0-15, higher scores indicate worse performance)
Time frame: 6 months
Mini Mental State Examination (Score range: 0-30, higher scores indicate better performance)
Time frame: 6 months
Short form-12 mental component summary score (Score range: 0-100, higher scores indicate better performance)
Time frame: 6 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 26 Mar 2018.
- Derived from this study: PubMed 31791364Hsieh TJ, Su SC, Chen CW, Kang YW, Hu MH, Hsu LL, Wu SY, Chen L, Chang HY, Chuang SY, Pan WH, Hsu CC. Individualized home-based exercise and nutrition interventions improve frailty in older adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2019 Dec 2;16(1):119. doi: 10.1186/s12966-019-0855-9.
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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.
Wen-Harn Pan, Ph.D. principal investigator
Institute of Biomedical Sciences, Academia Sinica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition, exercise and social network intervention in people with Frail Elderly, run by Academia Sinica, Taiwan at 1 site in Taiwan.
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 3 inclusion and 6 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 26 Mar 2018. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Frailty score (Score range: 0-5, higher scores indicate worse performance) (time frame: 6 months). 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 NCT03477097, 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 26 Mar 2018.