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Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation

NCT03477097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2018-03-26

No results posted yet for this study

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.

Conditions

  • Frail Elderly

Interventions

OTHER

Nutrition, exercise and social network intervention

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • Miaoli General Hospital, Ministry of Health and Welfare, Taiwan

    collaborator UNKNOWN

  • Academia Sinica, Taiwan

    lead OTHER

Principal Investigators

  • Wen-Harn Pan, Ph.D. · Institute of Biomedical Sciences, Academia Sinica

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03477097 on ClinicalTrials.gov