FPINPS: Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation

Sponsor

Academia Sinica, Taiwan (Other)

Overall Status

Completed

CT.gov ID

NCT03477097

Collaborator

National Health Research Institutes, Taiwan (Other), Miaoli General Hospital, Ministry of Health and Welfare, Taiwan (Other)

319

Enrollment

Location

Arms

Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Frail Elderly	Other: Nutrition, exercise and social network intervention	N/A

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

Study Type:

Interventional

Actual Enrollment :

319 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

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.	Other: Nutrition, exercise and social network intervention
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).	Other: Nutrition, exercise and social network intervention
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.	Other: Nutrition, exercise and social network intervention
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).	Other: Nutrition, exercise and social network intervention
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.	Other: Nutrition, exercise and social network intervention
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.	Other: Nutrition, exercise and social network intervention
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.	Other: Nutrition, exercise and social network intervention
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.	Other: Nutrition, exercise and social network intervention
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.	Other: Nutrition, exercise and social network intervention
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.	Other: Nutrition, exercise and social network 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.	Other: Nutrition, exercise and social network intervention

Outcome Measures

Primary Outcome Measures

Frailty score (Score range: 0-5, higher scores indicate worse performance) [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.

Secondary Outcome Measures

Handgrip strength [6 months]
Physical performance measure
Gait speed [6 months]
Physical performance measure
Back scratch [6 months]
Physical performance measure
Sit and reach [6 months]
Physical performance measure
Standing heel-rise [6 months]
Physical performance measure
Geriatric Depression Scale (Score range: 0-15, higher scores indicate worse performance) [6 months]
Mental Health measure
Mini Mental State Examination (Score range: 0-30, higher scores indicate better performance) [6 months]
Mental Health measure
Short form-12 mental component summary score (Score range: 0-100, higher scores indicate better performance) [6 months]
Mental Health measure

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)