Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation

NCT03477097 | Completed DMC

• 1 other identifier: AS-IRB-BM-15020
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly

Keywords

Frailty; Social Determinants; Biological Risk Factors; Intervention; Cost Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Handgrip strength

  6 months

• Gait speed

  6 months

• Back scratch

  6 months

• Sit and reach

  6 months

• Standing heel-rise

  6 months

Study Arms (12)

Control group w/o social network intervention

NO INTERVENTION

Subjects did not receive any intervention of nutrition, physical activity and social network.

Control group w/ social network intervention

EXPERIMENTAL

Subjects only received the intervention of social network.

Other: Nutrition, exercise and social network intervention

Nutrition group 1 w/o social network intervention

EXPERIMENTAL

Subjects only received the nutrition I intervention (e.g., food plate and multiple vitamin/ minerals powder).

Other: Nutrition, exercise and social network intervention

Nutrition group 1 w/ social network intervention

EXPERIMENTAL

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

Nutrition group 2 w/o social network intervention

EXPERIMENTAL

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

Nutrition group 2 w/ social network intervention

EXPERIMENTAL

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

Physical activity group w/o social network intervention

EXPERIMENTAL

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

Physical activity group w/ social network intervention

EXPERIMENTAL

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

Nutrition 1 + physical activity group w/o social network

EXPERIMENTAL

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

Nutrition 1 + physical activity group w/ social network

EXPERIMENTAL

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

Nutrition 2 + physical activity group w/o social network

EXPERIMENTAL

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

Nutrition 2 + physical activity group w/ social network

EXPERIMENTAL

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

Interventions

Nutrition, exercise and social network intervention OTHER

Control group w/ social network intervention; Nutrition 1 + physical activity group w/ social network; Nutrition 1 + physical activity group w/o social network; Nutrition 2 + physical activity group w/ social network; Nutrition 2 + physical activity group w/o social network; Nutrition group 1 w/ social network intervention; Nutrition group 1 w/o social network intervention; Nutrition group 2 w/ social network intervention; Nutrition group 2 w/o social network intervention; Physical activity group w/ social network intervention; Physical activity group w/o social network intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Academia Sinica, Taiwan: lead
• National Health Research Institutes, Taiwan: collaborator
• Miaoli General Hospital, Ministry of Health and Welfare, Taiwan: collaborator

Study Sites (1)

Miaoli General Hospital

Miaoli, 36054, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 31791364 DERIVED

MeSH Terms

Conditions

Frailty

Interventions

Nutritional Status; Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wen-Harn Pan, Ph.D.

  Institute of Biomedical Sciences, Academia Sinica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: March 26, 2018
• Study Start: October 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 26, 2018

Record last verified: 2018-03

Locations

TW (1)