Effectiveness of Graded Training in the Vivifrail Exercise Program Among Long-Term Care Residents

NCT06975449 | Completed

• 1 other identifier: CMUH114-REC3-034
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity; Aging; Frailty

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Control Group: Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Multicomponent Physical Exercise Program (Vivifrail)

Intervention Group: Multicomponent Physical Activity Program (Vivifrail)

EXPERIMENTAL

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.

Behavioral: Multicomponent Physical Exercise Program (Vivifrail)

Interventions

Multicomponent Physical Exercise Program (Vivifrail) BEHAVIORAL

Vivifrail physical training, 5 times/week, 50-60 minutes/session for 12 weeks

Control Group: Usual Care; Intervention Group: Multicomponent Physical Activity Program (Vivifrail)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, 406040, Taiwan

Location

MeSH Terms

Conditions

Frailty; Sedentary Behavior

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 16, 2025
• Study Start: May 20, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: March 24, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)