Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03477097
Study type Interventional
Source Academia Sinica, Taiwan
Contact
Status Completed
Phase N/A
Start date October 2015
Completion date June 2017

See also
  Status Clinical Trial Phase
Completed NCT02890927 - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital N/A
Completed NCT00384709 - Geriatric Education and Its Effect on Certain Aspects of Hospital Care of Nursing Home Patients N/A
Completed NCT05447533 - Clostridioides Difficile and Frailty N/A
Completed NCT03722017 - Drug Reduction in Older Patients: The DROP Trial N/A
Enrolling by invitation NCT05411393 - Synergizing Home Health Rehabilitation Therapy N/A
Recruiting NCT02333214 - Effectiveness of a Program Using Video Games Associated With Conventional Physiotherapy in Physical Functioning in Frail Elderly Compared to Conventional Physiotherapy N/A
Not yet recruiting NCT00756535 - Exercise Training in a Geriatric Hospital Ward N/A
Completed NCT01829594 - Case Managers to Frail Older People a Randomized Controlled Trial N/A
Not yet recruiting NCT05830942 - Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults N/A
Recruiting NCT04095338 - Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation N/A
Completed NCT02975089 - A Pilot Study Comparing Effects of Nutrients Supplements and Dietary Approach in Frailty Management N/A
Completed NCT01922167 - Resistance Exercise Training and Amino Acid Leucine Supplementation in Frail Elderly Women N/A
Completed NCT02591602 - Teleradiology Program for Frail Patients Living at Home or in Nursing-homes N/A
Completed NCT00105781 - Nurse Physical Activity Counseling in Primary Care N/A
Completed NCT05802537 - Home-Based Exergame Program for Community-Dwelling Older Adults N/A
Completed NCT03990415 - Stay Strong, Stay Healthy Outcomes in Older Adults N/A
Terminated NCT02766075 - A STEP for Patients Prior to Undergoing TAVR: A Pilot Study N/A
Completed NCT01607736 - Pilot Study of Virtual Gait Training in Older Adults N/A
Completed NCT00038155 - Rehabilitation for Older Adults From Acute Medical Conditions Phase 2
Completed NCT04885608 - PReGe in Outdoor Fitness Parks N/A