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

NCT ID: NCT06975449

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2026-02-20

Brief Summary

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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

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Conditions

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Frailty Physical Inactivity Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group: Usual Care

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.

Group Type ACTIVE_COMPARATOR

Multicomponent Physical Exercise Program (Vivifrail)

Intervention Type BEHAVIORAL

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

Intervention Group: Multicomponent Physical Activity Program (Vivifrail)

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.

Group Type EXPERIMENTAL

Multicomponent Physical Exercise Program (Vivifrail)

Intervention Type BEHAVIORAL

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

Interventions

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Multicomponent Physical Exercise Program (Vivifrail)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥70, resident in LTC center, ambulatory, physician-cleared for training
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shu Hua Lu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China Medical University

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Shu-Hua Lu, Associate Professor

Role: CONTACT

+886-04-22053366 ext. 7133

Facility Contacts

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Shu-Hua Lu, Associate Professor

Role: primary

886+04-22053366

Other Identifiers

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CMUH114-REC3-034

Identifier Type: -

Identifier Source: org_study_id

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