Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program

NCT07519603 | Recruiting

• 2 other identifiers: NGH002198HOSVu Thi Diu
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Frailty is common among older patients with chronic obstructive pulmonary disease (COPD) and is associated with poor functional outcomes and increased health risks. This study aims to determine the prevalence of frailty and to evaluate the effects of the Vivifrail exercise program on physical performance, activities of daily living, and quality of life in older COPD patients at Hospital 198, Ministry of Public Security, Vietnam.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Frailty

Keywords

COPD; Frailty; Older Adults; Vivifrail; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Short Physical Performance Battery (SPPB) score

  The Short Physical Performance Battery (SPPB) assesses lower extremity function including balance, gait speed, and chair stand. Scores range from 0 to 12, with higher scores indicating better physical performance.

  baseline to 6 months

Secondary Outcomes (3)

• Change in frailty status assessed by Fried frail

  Baseline to 6 months

• Change in handgrip strength (kg)

  baseline to 6 months

• Change in COPD Assessment Test (CAT) score

  Baseline to 6 months

Study Arms (2)

Vivifrail Exersise Group

EXPERIMENTAL

Participants receive the Vivifrail Exercise program

Behavioral: Vivifrail Exercise program

Usual Care Group

ACTIVE COMPARATOR

Participants receive standard care without structured Exercise

Other: Usual Care Group

Interventions

Vivifrail Exercise program BEHAVIORAL

The Vivifrail exercise program is a structured, multicomponent intervention designed for older adults. It includes individualized exercises focusing on strength, balance, flexibility, and aerobic capacity based on the participant's functional level. The program is performed regularly under supervision or guidance to improve physical performance, reduce frailty, and enhance quality of life

Vivifrail Exersise Group

Usual Care Group OTHER

Participants receive standard care without structured exercise intervention

Usual Care Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years
• Diagnosis of COPD according to GOLD criteria
• Clinically stable COPD (no exacerbation within the past 4 weeks)
• Able to participate in exercise training
• Provide informed consent

You may not qualify if:

• Acute COPD exacerbation within the past 4 weeks
• Severe cardiovascular disease limiting exercise
• Severe cognitive impairment
• Musculoskeletal disorders preventing exercise
• Participation in another clinical trial

Sponsors & Collaborators

• National Geriatric Hospital: lead

Study Sites (2)

Hospital 198, Ministry of Public Security

Hanoi, Hanoi, Vietnam

RECRUITING

Hospital 198, Ministry of Public Security

Hanoi, Vietnam

RECRUITING

Related Publications (2)

• Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11.

  PMID: 35150086 BACKGROUND

• Azhimamatova R, Salieva RS, Zalova TB, Karimova K, Karimova DS, Dyikanova SA, Kalmatov R, Tynaliev UM. Frailty in COPD: Clinical Impact, Diagnosis, Biomarkers, and Management Strategies. Int J Chron Obstruct Pulmon Dis. 2025 Jul 15;20:2445-2458. doi: 10.2147/COPD.S522862. eCollection 2025.

  PMID: 40688238 BACKGROUND

Related Links

• Frailty is a complex clinical syndrome characterized by reduced physiological resilience and heightened susceptibility to external stressors, culminating in increased risks of functional decline, hospitalization, and mortality. In individuals with chroni
• Vivifrail Physical Exercise Passport for Professionals The passport of physical exercise is aimed at professionals and specialists in physical exercise. You can find all the necessary steps for the implementation of the Vivifrail program.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Frailty

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diu Thi Vu, MD, MSc

  Hanoi Medical University, Vietnam; Hospital 198, Ministry of Puplic Security, Vietnam; National Geriatric Hospital, Vietnam

  PRINCIPAL INVESTIGATOR

• Huyen Thanh Thi Vu, Associate Prof. PhD

  Hanoi Medical University, Vietnam; National Geriatric Hospital, Vietnam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diu Thi Vu, MD, MSc

CONTACT

+84 912 088 986; vudiu198@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to either the intervention group receiving the Vivifrail exercise program or a control group receiving standard care.

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)