Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorNational Geriatric Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Acute COPD exacerbation within the past 4 weeks
Severe cardiovascular disease limiting exercise
Severe cognitive impairment
Musculoskeletal disorders preventing exercise
Trial design
Design model
Parallel
Treatments tested in this trial
Vivifrail Exercise program
BehavioralThe 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 Group
Other interventionParticipants receive standard care without structured exercise intervention
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Vivifrail Exersise GroupExperimental treatment 1 intervention
Group B: Usual Care GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
baseline to 6 monthsSecondary outcomes
1
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.
Time frame
Baseline to 6 months2
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
Time frame
baseline to 6 months3
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.
Time frame
Baseline to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov