Validation the Effectiveness of Graded Training in the MultiComponent Physical Exercise Program (Vivifrail) Among Senile Care Center Residents: A Randomized Controlled Study

China Medical University

Status: Not yet enrolling

Conditions: Aging; Physical Inactivity; Frailty

Treatments: Behavioral: Multicomponent Physical Exercise Program (Vivifrail)

Study type: Interventional

Funder types: Other

Identifiers

NCT06975449

CMUH114-REC3-034

Details and patient eligibility

About

This study evaluates the effectiveness of the Vivifrail multicomponent physical exercise program among elderly residents with different levels of frailty in long-term care centers. A 12-week intervention will be conducted in randomly assigned experimental and control groups. Outcomes include physical performance, fall risk, grip strength, calf circumference, and ICOPE function.

Enrollment: 80 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥70, resident in LTC center, ambulatory, physician-cleared for training

Exclusion criteria

• Conditions listed in Vivifrail exclusion criteria (e.g., acute MI, unstable angina, recent fractures, uncontrolled hypertension, etc.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Control Group: Usual Care

Active Comparator group

Description:

Participants in this group will receive usual care with no structured physical activity program. They will continue their normal daily routines and have access to health education materials unrelated to physical activity.

Treatment:

Behavioral: Multicomponent Physical Exercise Program (Vivifrail)

Intervention Group: Multicomponent Physical Activity Program (Vivifrail)

Experimental group

Description:

Participants in this arm will receive a 12-week multicomponent physical activity program based on the Vivifrail protocol, designed to improve physical function and reduce frailty in older adults. The intervention includes individualized exercise sessions incorporating strength, balance, flexibility, and endurance training, adjusted according to baseline functional capacity. Sessions are supervised by trained personnel and conducted three times per week in a community or long-term care setting. The program also includes educational components promoting adherence and safe exercise practices.

Treatment:

Behavioral: Multicomponent Physical Exercise Program (Vivifrail)