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NCT Number: NCT05935319

VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly

The global population is aging, and Taiwan has become an aging society. The aging population continues to rise. When the physical function and mental state of the elderly gradually decline, it is easy for the elderly to enter a state of physical weakness. Weakness is the decline in the reserve capacity of the physiological system. It is also related to geriatric syndrome, causing falls, hospitalization, disability, death, and increased medical costs, burden on primary caregivers, and reduced quality of life for the elderly.

Physical exercise training has been considered to be an effective strategy to prevent and delay disability and frailty, so this study uses the Vivifrail program for the elderly. A family-based 12-week exercise program, including: resistance, strength, balance, flexibility and cardiorespiratory endurance exercise training, performed five days a week, at least 45-60 minutes each time, so that the elderly can exercise at home, It can also improve physical function and improve the quality of life.

This study adopts a randomized controlled trial (RCT) with a one-group pretest-posttest design, with pre-frail and frail elderly as the research objects, and uses comprehensive assessment of the elderly to understand the physical function of the elderly Status, Vivifrail for the elderly was provided for abnormal physical function items, and post-test evaluation was carried out 4 weeks and 12 weeks after the intervention. In Taiwan, there is no research on Vivifrail for the frail elderly. In view of this, it is hoped that through the Vivifrail program and the follow-up of case managers, multi-faceted and continuous integrated care can be provided. Improve and maintain the physical function of the frail elderly for reference in the daily care of the elderly in the future.

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Key information

Conditions

Frailty Behavior Cognitive Function Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WangJiaJie

Hualien City, 970, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ≧65 years old and above.
  • Pre-frail and frail cases assessed by Frail Fried's frail phenotype.
  • Clear consciousness, willing to accept interviewers, able to communicate in Chinese and Taiwanese.
  • Those who can cooperate with physical activities and have ADL ≥ 60 points.

Exclusion criteria

  • Those who cannot cooperate with the interventional care plan.
  • Elderly who are seriously ill or terminally ill.
  • People living in institutions.
  • Incompatibility and exclusion: acute myocardial infarction or recent unstable angina, poorly controlled atrial or ventricular arrhythmia, dissected aortic aneurysm, severe aortic stenosis, endocarditis/acute cardiac Capsulitis, uncontrolled hypertension, acute thromboembolism, acute or severe heart failure, acute or severe respiratory failure, uncontrolled postural hypotension, acute incompensated diabetes mellitus, or uncontrolled hypoglycemia, past month There is a fracture (muscle strength training).

Treatment and study plan

Vivifrail

Other

Assess the physical activity status of the elderly, use the Vivifrail grade, provide exercise intervention, and improve physical activity function.

Primary outcomes

  1. Hand Grip

    Time frame: 1-2 minutes

    Grip strength defined as <28 kg for men and <18 kg for women

  2. Short Physical Performance Battery(SPPB)

    Time frame: 5-10 minutes

    ≦9 points abnormal, 10-12 normal.

  3. Activities of Daily Living(ADL)

    Time frame: 2-5 minutes

    The full score is 100 points, 0-20 points are completely dependent, 21-60 points are heavily dependent, 61-90 points are moderately dependent, 91-99 points are slightly dependent, and 100 points are completely independent.

  4. Instrumental Activities of Daily Living(IADL)

    Time frame: 2-5 minutes

    The full score is 8 points, the higher the score, the better the function.

  5. Mini-Mental State Examination(MMSE)

    Time frame: 10-20 minutes

    junior high school ≧ 24 points, elementary school ≧ 21 points, those without education ≧ 16 points.

  6. Geriatric Depression Scale(GDS- 15)

    Time frame: 10-20 minutes

    The full score is 15 points, 0-4 points are normal, 5-9 points are mild depression, 10-14 points are moderate depression, and more than 15 points are depression.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

The Effectiveness of a VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
Jul 11, 2025

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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