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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07519603
Acronym
COPD-FRAIL
Enrollment
80
Registered
2026-04-09
Start date
2026-03-01
Completion date
2027-01-01
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD), Frailty

Keywords

COPD, Frailty, Older Adults, Vivifrail, Pulmonary Rehabilitation

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.

Detailed description

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. Frailty is a multidimensional geriatric syndrome characterized by decreased physiological reserve and increased vulnerability to adverse health outcomes. It is highly prevalent among older patients with chronic obstructive pulmonary disease (COPD), contributing to functional decline, increased risk of hospitalization, and mortality. COPD is a chronic respiratory condition associated with systemic manifestations, including muscle weakness, reduced physical activity, and comorbidities, all of which may accelerate the development of frailty. The coexistence of COPD and frailty leads to worse clinical outcomes and reduced quality of life. The Vivifrail exercise program is an evidence-based intervention specifically designed to improve physical function and reduce frailty in older adults through individualized exercise training. Previous studies have demonstrated its effectiveness in improving muscle strength, balance, and functional capacity. However, evidence regarding its effectiveness in older COPD patients, particularly in Vietnam, remains limited. Therefore, this study aims to assess the prevalence of frailty and evaluate the effects of the Vivifrail exercise program on physical performance, activities of daily living, and quality of life in older patients with COPD.

Interventions

OTHERUsual Care Group

Participants receive standard care without structured exercise intervention

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

Sponsors

National Geriatric Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Short Physical Performance Battery (SPPB) scorebaseline to 6 monthsThe 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.

Secondary

MeasureTime frameDescription
Change in frailty status assessed by Fried frailBaseline to 6 monthsFrailty status will be assessed using the Fried frailty phenotype, which includes five components: unintentional weight loss (≥5% body weight in the past year), self-reported exhaustion (assessed by standardized questionnaire), low physical activity level, slowness (measured by gait speed over a 4-meter walk), and weakness (assessed by handgrip strength using a calibrated dynamometer). Each component is scored as present or absent. Participants meeting 3 or more criteria are classified as frail, those with 1-2 criteria as prefrail, and those with 0 criteria as robust. Change in frailty status will be defined as the transition between these categories from baseline to 6 months.
Change in handgrip strength (kg)baseline to 6 monthsHandgrip strength is assessed using a calibrated handheld dynamometer. The best value of three attempts for the dominant hand is recorded in kilograms (kg). Higher values indicate greater muscle strength
Change in COPD Assessment Test (CAT) scoreBaseline to 6 monthsThe COPD Assessment Test (CAT) evaluates health-related quality of life in patients with COPD. Scores range from 0 to 40, with higher scores indicating worse symptoms.

Countries

Vietnam

Contacts

CONTACTDiu Thi Vu, MD, MSc
vudiu198@gmail.com+84 912 088 986
PRINCIPAL_INVESTIGATORDiu Thi Vu, MD, MSc

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

PRINCIPAL_INVESTIGATORHuyen Thanh Thi Vu, Associate Prof. PhD

Hanoi Medical University, Vietnam; National Geriatric Hospital, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026