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

Not Applicable

Not yet recruiting

• Conditions: Frailty; Physical Inactivity; Aging

• Registration Number: NCT06975449
• Lead Sponsor: China Medical University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Study Start: 2025-05-20
• Primary Completion: 2026-02-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24	SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24	SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24
Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24	Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24	Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24

Secondary Outcome Measures

Name	Time	Method
ICOPE function assessment at Weeks 0, 12, 24	ICOPE function assessment at Weeks 0, 12, 24	ICOPE function assessment at Weeks 0, 12, 24
Grip strength (hand dynamometer) at Weeks 0, 12, 24	Grip strength (hand dynamometer) at Weeks 0, 12, 24	Grip strength (hand dynamometer) at Weeks 0, 12, 24

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan