Frailty/SarcopeniaNCT07732478
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
A study testing Multicomponent Exercise Program (Vivifrail-based) in people with Frailty/Sarcopenia and Frailty in Older Adults, run by Universidad de Granada at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty/Sarcopenia, Frailty in Older Adults, Sarcopenia
- What is being tested?
- Multicomponent Exercise Program (Vivifrail-based)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2026to 31 Jul 2030
- Phase
- Interventional
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Independent, community-dwelling (not institutionalized)
- Barthel Index score ≥ 90 points (no significant disability)
- Timed Up and Go (TUG) test ≥ 10 seconds
- Short Physical Performance Battery (SPPB) score below 12 points (indicating possible frailty)
- Fall risk indicated by at least one of the following: one fall in the past year requiring assistance, more than one fall without assistance, TUG > 20 seconds, or gait speed over 6 meters > 7.50 seconds
- Reduced grip strength: below 27 kg (men) or below 16 kg (women), or more than 15 seconds to complete 5 chair stands
- Voluntary signed informed consent
Who cannot join
- Terminal illness
- Residing in a nursing home
- Diagnosed with, or under investigation for, moderate to severe cognitive impairment
- Unstable cardiovascular disease
- Acute infectious disease
- Uncontrolled hypertension (systolic > 180 mmHg or diastolic > 110 mmHg)
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- Uncontrolled diabetes
- Advanced organ failure
- Disabling musculoskeletal condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andrés B. Fernández-Revelles, Sport Sciences contact
Spain1 site, 1 recruiting
- Recruiting
Faculty of Sports Science
Granada, Andalusia, 18004
Andrés B. Fernández-Revelles, Principal Investigator, Sport Science, +34 958246635, abfr@ugr.es
About this study
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.
Read the detailed description
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).
- Conditions
- Frailty/Sarcopenia, Frailty in Older Adults, Sarcopenia
- Being tested
- Multicomponent Exercise Program (Vivifrail-based)
- Keywords
- Multicomponent exercise, Community-based exercise program, Older adults, Physical function, Frailty prevention, Sarcopenia, Muscle strength, Cardiorespiratory fitness, Fall prevention, Real-world effectiveness
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Exercise Program (Vivifrail-based)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community Multicomponent Exercise Program | Experimental | 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. Receives: Behavioral: Multicomponent Exercise Program (Vivifrail-based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Secondary outcomes (6)
Handgrip strength
Isometric strength of the upper limb measured using a Jamar-type hand dynamometer, expressed in kilograms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty/SarcopeniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER FERNÁNDEZ-ORTEGA, Universidad de Granada
- Investigators
- Andrés B. Fernández-Revelles, Sport Science, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732478
- Sponsor's protocol ID
- #6186
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.