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NCT Number: NCT03477097

Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation

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.

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Key information

Conditions

Frail Elderly Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miaoli General Hospital

Miaoli, 36054, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nutrition, exercise and social network intervention

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. Handgrip strength

    Time frame: 6 months

    Physical performance measure

  2. Gait speed

    Time frame: 6 months

    Physical performance measure

  3. Back scratch

    Time frame: 6 months

    Physical performance measure

  4. Sit and reach

    Time frame: 6 months

    Physical performance measure

  5. Standing heel-rise

    Time frame: 6 months

    Physical performance measure

  6. Geriatric Depression Scale (Score range: 0-15, higher scores indicate worse performance)

    Time frame: 6 months

    Mental Health measure

  7. Mini Mental State Examination (Score range: 0-30, higher scores indicate better performance)

    Time frame: 6 months

    Mental Health measure

  8. Short form-12 mental component summary score (Score range: 0-100, higher scores indicate better performance)

    Time frame: 6 months

    Mental Health measure

Sponsors and collaborators

Lead sponsor

Academia Sinica, Taiwan

Other

Collaborators

  • Miaoli General Hospital, Ministry of Health and Welfare, Taiwan
  • National Health Research Institutes, Taiwan

Registry information

Acronym: FPINPS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2018
Registry last updated
Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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