An interventional study of Multicomponent Exercise Program (Vivifrail-based) in Frailty/Sarcopenia, Frailty in Older Adults and Sarcopenia, sponsored by Universidad de Granada. Recruiting at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment
This study evaluates the effects of a community-based multicomponent exercise program on physical function, frailty, and sarcopenia in older adults living in the municipality of Santoña (Cantabria, Spain). The exercise program is organized and delivered by the Santoña Town Council as part of its public health services for older residents and is not created for research purposes; it will continue regardless of the outcome of this study. Researchers are only evaluating participants who voluntarily agree to be assessed before and after each 36-week cycle of the program, over four consecutive academic years (2026-2030). The main question this study aims to answer is whether continued participation in this real-world, community-based multicomponent exercise program (based on the Vivifrail model) leads to meaningful improvements in physical function, muscle strength, and cardiorespiratory capacity, and helps reverse indicators of frailty and sarcopenia in independent, community-dwelling older adults. Participants will complete functional and physical tests, including balance, gait speed, chair-stand performance, handgrip strength, and a 6-minute walk test, at the start and end of each 36-week exercise cycle. No blood or biological samples will be collected.
Most of the existing evidence on the benefits of multicomponent exercise for reversing frailty and sarcopenia in older adults comes from lab-based clinical trials conducted in highly controlled hospital or laboratory settings. While these studies have strong internal validity, they often lack ecological validity, meaning they do not reflect the real-world conditions, barriers, and adherence dynamics of community-based programs. There is therefore a public health need to evaluate whether the efficacy demonstrated in controlled settings translates into real, sustainable effectiveness when delivered through existing municipal, real-world programs.
This study evaluates a pre-existing, independently run community exercise program organized by the Santoña Town Council (Cantabria, Spain) for older adults referred through local health centers. The program has been running for several years and will continue to be delivered by the Town Council regardless of this study's outcome. The scope of this research is limited to the scientific evaluation of participants' physical and functional status before and after their participation in the program; the research team has no role in designing, modifying, or delivering the exercise intervention itself.
Design: This is a quasi-experimental, single-group, repeated-measures (pre-post) study. A passive control group was not included, as the community health-promotion nature of the program makes it inappropriate to withhold access to exercise and its benefits from eligible older residents. Each participant serves as their own control, comparing baseline and post-intervention measures.
Intervention being evaluated: The municipal exercise program follows a 36-week multicomponent format addressing strength, balance, endurance, and flexibility, structured according to the FITT-VP principles of the Vivifrail model (Izquierdo, 2019). Sessions are supervised by qualified exercise professionals who individualize training loads. The research team is not modifying this program in any way; researchers are solely adding an assessment protocol before and after each 36-week cycle.
Recruitment and timeframe: Recruitment will take place annually over four consecutive academic years (2026/2027 to 2029/2030), with an estimated 60 participants recruited per cohort, for a cumulative total of approximately 240 participants across the study period.
Outcome assessment: At baseline (week 0) and at the end of each 36-week cycle (week 36), participants will undergo: basic anthropometric measurements (weight, height, waist circumference); a self-perceived fitness questionnaire (IFIS); the Short Physical Performance Battery (SPPB), assessing balance, 4-meter gait speed, and 5-times chair-stand performance; handgrip strength via isometric dynamometry; the 30-Second Chair Stand Test as an additional measure of lower-limb strength; and the 6-Minute Walk Test to assess cardiorespiratory capacity. No blood draws, biopsies, or other biological samples are collected at any point.
Safety considerations: Because participants are community-dwelling older adults rather than clinical patients, the assessment protocol does not interfere with any necessary medical treatment, and no placebo is used. Expected adverse effects are mild and transient (e.g., delayed-onset muscle soreness, general fatigue, occasional mild joint discomfort), with a low inherent risk of musculoskeletal injury or falls associated with physical exertion. All sessions are supervised by qualified exercise professionals, loads are individualized, and an adverse event monitoring and reporting protocol is in place. Participants are covered by the Santoña Town Council's civil liability insurance for municipal activities and facilities.
Setting: Data collection and the exercise program take place at municipal sports facilities and community centers made available by the Santoña Town Council under an institutional collaboration agreement. Scientific direction, statistical analysis, and custody of anonymized data are centrally managed by the research team at the University of Granada (UGR).
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 300 is above the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants aged 65 and older meeting the inclusion criteria take part in the pre-existing 36-week multicomponent exercise program delivered by the Santoña Town Council. Functional and physical assessments are performed at baseline (week 0) and at the end of each 36-week cycle (week 36), across four consecutive academic years. Each participant serves as their own control.
Behavioral: Multicomponent Exercise Program (Vivifrail-based)
A 36-week community-based multicomponent exercise program addressing strength, balance, endurance, and flexibility, structured according to the Vivifrail FITT-VP model. Sessions are delivered by qualified exercise professionals as part of the Santoña Town Council's existing public health services, independently of this study.
Short Physical Performance Battery (SPPB) score
Composite score assessing lower-extremity physical function through three components - standing balance, 4-meter gait speed, and time to complete five repeated chair stands. Total score ranges from 0 to 12, with lower scores indicating greater physical frailty.
Time frame: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Handgrip strength
Isometric strength of the upper limb measured using a Jamar-type hand dynamometer, expressed in kilograms.
Time frame: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
30-Second Chair Stand Test
Number of full stands completed from a seated position in 30 seconds, used as a measure of lower-limb muscular strength and endurance.
Time frame: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
6-Minute Walk Test (6MWT) distance
Total distance (in meters) walked in 6 minutes, used as a measure of cardiorespiratory capacity and functional exercise tolerance.
Time frame: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Body weight and Body Mass Index (BMI)
Body weight (kg) and BMI, calculated from measured weight and height, assessed as basic anthropometric indicators.
Time frame: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Waist circumference
Waist circumference (cm), used as an indicator of central adiposity.
Time frame: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Self-perceived fitness (International Fitness Scale, IFIS)
Self-reported perception of overall physical fitness and its four specific dimensions (cardiorespiratory fitness, muscular strength, speed-agility, and flexibility) assessed using the International Fitness Scale (IFIS). The scale consists of 5 main items, each evaluated on a 5-point Likert scale ranging from 1 ("very poor") to 5 ("very good"). Each individual item score ranges from 1 to 5, where higher scores indicate better self-perceived physical fitness.
Time frame: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data collected during the study (anthropometric, functional, and cardiorespiratory outcome measures) will be made available, along with an accompanying data dictionary describing all variables collected.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning after publication of the main results article associated with each cohort, with no specified end date.
Access criteria: Data will be made available to researchers who provide a methodologically sound proposal, upon reasonable request to the corresponding author. Requests should specify the intended use of the data and will be reviewed by the research team.
Start is estimated for Oct 2026; primary completion for Jun 2030, 44 months later.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 44 months is above that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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