Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation

Frail Elderly Clinical Trial

— FPINPS  

Official title:

Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477097
• Other study ID #: AS-IRB-BM-15020
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: March 23, 2018
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2018
• Source: Academia Sinica, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Frail Elderly

Intervention

Other:
• Nutrition, exercise and social network intervention

Locations

Country	Name	City	State
Taiwan	Miaoli General Hospital	Miaoli

Sponsors (3)

Lead Sponsor	Collaborator
Academia Sinica, Taiwan	Miaoli General Hospital, Ministry of Health and Welfare, Taiwan, National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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