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

April 6, 2026 updated by: National Geriatric Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Recruiting
        • Hospital 198, Ministry of Public Security
    • Hanoi
      • Hanoi, Hanoi, Vietnam
        • Recruiting
        • Hospital 198, Ministry of Public Security
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vivifrail Exersise Group
Participants receive the Vivifrail Exercise program
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
Active Comparator: Usual Care Group
Participants receive standard care without structured Exercise
Other: Usual Care Group
Participants receive standard care without structured exercise intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Short Physical Performance Battery (SPPB) score
Time Frame: baseline to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in frailty status assessed by Fried frail
Time Frame: Baseline to 6 months

Frailty 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.
Baseline to 6 months
Change in handgrip strength (kg)
Time Frame: baseline to 6 months
Handgrip 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
baseline to 6 months
Change in COPD Assessment Test (CAT) score
Time Frame: Baseline to 6 months
The 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.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Geriatric Hospital

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NGH002198HOS
  • Vu Thi Diu (Other Identifier: Vietnam)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Frailty

Clinical Trials on Vivifrail Exercise program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe