Chronic Obstructive Pulmonary Disease (COPD)COPD-FRAILNCT07519603
Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program
A study testing Vivifrail Exercise program in people with Chronic Obstructive Pulmonary Disease (COPD) and Frailty, run by National Geriatric Hospital at 2 sites in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Frailty
- What is being tested?
- Vivifrail Exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Mar 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
Hospital 198, Ministry of Public Security
Hanoi, Hanoi
Diu Thi Vu, MD, MSc, +84 912 088 986, vudiu198@gmail.com
- Recruiting
Hospital 198, Ministry of Public Security
Hanoi
About this study
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.
Read the 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.
- Being tested
- Vivifrail Exercise program, Usual Care Group
- Keywords
- COPD, Frailty, Older Adults, Vivifrail, Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivifrail Exercise programBehavioural
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
Usual Care GroupOther
Participants receive standard care without structured exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Vivifrail Exersise Group | Experimental | Participants receive the Vivifrail Exercise program Receives: Behavioral: Vivifrail Exercise program |
| Usual Care Group | Active comparator | Participants receive standard care without structured Exercise Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 6 months
Secondary outcomes (3)
Change in frailty status assessed by Fried frail
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.
Measured: Baseline to 6 months
Change in handgrip strength (kg)
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
Measured: baseline to 6 months
Change in COPD Assessment Test (CAT) score
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either the intervention group receiving the Vivifrail exercise program or a control group receiving standard care.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Geriatric Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Diu Thi Vu, MD, MSc, Principal investigator, Hanoi Medical University, Vietnam; Hospital 198, Ministry of Puplic Security, Vietnam; National Geriatric Hospital, VietnamHuyen Thanh Thi Vu, Associate Prof. PhD, Principal investigator, Hanoi Medical University, Vietnam; National Geriatric Hospital, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519603
- Sponsor's protocol ID
- NGH002198HOS
- Other IDs
- Vu Thi Diu
- Acronym
- COPD-FRAIL
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11.
PubMed 35150086Azhimamatova 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.
PubMed 40688238
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program
- ClinicalTrials.gov ID
- NCT07519603
- Acronym / sponsor ID
- COPD-FRAIL / NGH002198HOS
- Keywords
- COPD, Frailty, Older Adults, Vivifrail, Pulmonary Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Geriatric HospitalOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to either the intervention group receiving the Vivifrail exercise program or a control group receiving standard care.
| Arm | Type | Receives |
|---|---|---|
| Vivifrail Exersise Group | Experimental | Behavioral: Vivifrail Exercise programParticipants receive the Vivifrail Exercise program |
| Usual Care Group | Active comparator | Other: Usual Care GroupParticipants receive standard care without structured Exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivifrail Exercise programThe 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 | Behavioural | Vivifrail Exersise Group |
| Usual Care GroupParticipants receive standard care without structured exercise intervention | Other | Usual Care Group |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 35150086Casas-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.
- Background: PubMed 40688238Azhimamatova 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.
- 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 chroniLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diu Thi Vu, MD, MSc principal investigator
Hanoi Medical University, Vietnam; Hospital 198, Ministry of Puplic Security, Vietnam; National Geriatric Hospital, Vietnam
Huyen Thanh Thi Vu, Associate Prof. PhD principal investigator
Hanoi Medical University, Vietnam; National Geriatric Hospital, Vietnam
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivifrail Exercise program in people with Chronic Obstructive Pulmonary Disease (COPD) and Frailty, run by National Geriatric Hospital at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diu Thi Vu, MD, MSc (+84 912 088 986, vudiu198@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Physical Performance Battery (SPPB) score (time frame: baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07519603, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.