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Recruiting NCT07519603

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

No phase Interventional Chronic Obstructive Pulmonary Disease (COPD) Frailty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vivifrail Exercise program, Usual Care Group.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease (COPD), Frailty. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Behavioral Vivifrail Exercise program
    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
  • Other Usual Care Group
    Participants receive standard care without structured exercise intervention

Primary outcome measures

  • Change in Short Physical Performance Battery (SPPB) score [Time frame: baseline to 6 months]
Secondary outcome measures (3)
  • Change in frailty status assessed by Fried frail [Time frame: Baseline to 6 months]
  • Change in handgrip strength (kg) [Time frame: baseline to 6 months]
  • Change in COPD Assessment Test (CAT) score [Time frame: Baseline to 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Vietnam · 2 centers
  • Hospital 198, Ministry of Public Security — Hanoi
  • Hospital 198, Ministry of Public Security — Hanoi

Publications

  • 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. 20 PMID 35150086
  • 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

Identifiers

NCT: NCT07519603 · NGH002198HOS · Vu Thi Diu

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗