- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03477097
Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation (FPINPS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Miaoli, Taiwan, 36054
- Miaoli General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control group w/o social network intervention
Subjects did not receive any intervention of nutrition, physical activity and social network.
|
|
EXPERIMENTAL: Control group w/ social network intervention
Subjects only received the intervention of social network.
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EXPERIMENTAL: Nutrition group 1 w/o social network intervention
Subjects only received the nutrition I intervention (e.g., food plate and multiple vitamin/ minerals powder).
|
|
EXPERIMENTAL: Nutrition group 1 w/ social network intervention
Subjects received the nutrition I intervention (e.g., food plate and multiple vitamin/ minerals powder) and social network intervention as well.
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|
EXPERIMENTAL: Nutrition group 2 w/o social network intervention
Subjects only received the nutrition II intervention (e.g., food plate, multiple vitamin/ minerals powder, fruit/vegetable concentrate capsule, and fish oil).
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EXPERIMENTAL: Nutrition group 2 w/ social network intervention
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.
|
|
EXPERIMENTAL: Physical activity group w/o social network intervention
Subjects only received the personalized homed-based exercise prescription, which consisted of a combination of strength, flexibility, balance and endurance training.
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EXPERIMENTAL: Physical activity group w/ social network intervention
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.
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EXPERIMENTAL: Nutrition 1 + physical activity group w/o social network
Subjects received the nutrition I (e.g., food plate and multiple vitamin/ minerals powder) and exercise (e.g., personalized homed-based exercise plan) intervention.
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EXPERIMENTAL: Nutrition 1 + physical activity group w/ social network
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.
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|
EXPERIMENTAL: Nutrition 2 + physical activity group w/o social network
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.
|
|
EXPERIMENTAL: Nutrition 2 + physical activity group w/ social network
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Handgrip strength
Time Frame: 6 months
|
Physical performance measure
|
6 months
|
Gait speed
Time Frame: 6 months
|
Physical performance measure
|
6 months
|
Back scratch
Time Frame: 6 months
|
Physical performance measure
|
6 months
|
Sit and reach
Time Frame: 6 months
|
Physical performance measure
|
6 months
|
Standing heel-rise
Time Frame: 6 months
|
Physical performance measure
|
6 months
|
Geriatric Depression Scale (Score range: 0-15, higher scores indicate worse performance)
Time Frame: 6 months
|
Mental Health measure
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6 months
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Mini Mental State Examination (Score range: 0-30, higher scores indicate better performance)
Time Frame: 6 months
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Mental Health measure
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6 months
|
Short form-12 mental component summary score (Score range: 0-100, higher scores indicate better performance)
Time Frame: 6 months
|
Mental Health measure
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6 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AS-IRB-BM-15020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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