Clinical trial NCT03477097: Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation
Official title: Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Keywords: Frailty
Social Determinants
Biological Risk Factors
Intervention
Cost Effectiveness
Lead sponsor: Academia Sinica, Taiwan
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
name: Miaoli General Hospital, Ministry of Health and Welfare, Taiwan
First posted: 2018-03-26
Enrollment: 319
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Frailty score (Score range: 0-5, higher scores indicate worse performance)
timeFrame: 6 months
Secondary outcomes:
measure: Handgrip strength
timeFrame: 6 months
measure: Gait speed
timeFrame: 6 months
measure: Back scratch
timeFrame: 6 months
measure: Sit and reach
timeFrame: 6 months
measure: Standing heel-rise
timeFrame: 6 months
measure: Geriatric Depression Scale (Score range: 0-15, higher scores indicate worse performance)
timeFrame: 6 months
measure: Mini Mental State Examination (Score range: 0-30, higher scores indicate better performance)
timeFrame: 6 months
measure: Short form-12 mental component summary score (Score range: 0-100, higher scores indicate better performance)
timeFrame: 6 months
Other outcomes:
Locations:
city: Miaoli
country: Taiwan
facility: Miaoli General Hospital
Study officials:
affiliation: Institute of Biomedical Sciences, Academia Sinica
name: Wen-Harn Pan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.