Frailty+AGILNCT06836167
+AGIL Barcelona: Integrated Care for Community-Dwelling Frail Older Adults
A study testing exercise promotion, review medication and promoting healthy aging in people with Frailty and Older Adults, run by Parc Sanitari Pere Virgili at 3 sites in Spain.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of the +AGIL Barcelona program in helping older adults improve their physical abilities and delay disability. It will also explore how to adapt and expand the program to different neighborhoods in Barcelona. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Older Adults, Healthy Aging
- What is being tested?
- exercise promotion, review medication and promoting healthy aging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 3 sitesSpain
- Study dates
- 2 Nov 2022to 31 Jul 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- People aged 65 or older
- Presenting with suggestive signs of frailty according to the Gérontopôle Frailty Screening Test (GFST).
- Agree to participate and sign informed consent
Who cannot join
- Requirement for hospital admission or an estimated life expectancy of less than one year.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Barceloneta - Primary Care Center
Barcelona
Alba Gomez, PT, +34932 21 37 83, agomezb@perevirgili.cat
Sonia Baro, MD
- Recruiting
Larrad - Primary Care Center
Barcelona
Sonia Baro, MD, +34932 85 76 00, sbaro@perevirgili.cat
Sonia Baro, MD
- Recruiting
Vila Olimpica - Primary Care Center
Barcelona
Adria Falo, PT, +34932 21 37 85, afalo@perevirgili.cat
Sonia Baro, MD
About this study
Official title: + AGIL Barcelona: Integrated Care for Community-Dwelling Frail Older Adults
The goal of this clinical trial is to evaluate the effectiveness of the +AGIL Barcelona program in helping older adults improve their physical abilities and delay disability. It will also explore how to adapt and expand the program to different neighborhoods in Barcelona. The main questions it aims to answer are:
Does the +AGIL program improve physical abilities, as measured by a simple physical performance test (SPPB)? How well can the program be adapted and implemented in different community health centers? Researchers will conduct the study in three community health centers in Barcelona, following a stepped approach to gradually introduce the program at each site.
Read more
Participants will:
Participate in up to 10 weekly group exercise sessions led by a physiotherapist. Focus on strength, balance, flexibility, and endurance. Exercises will be tailored to individual needs and supported with easy-to-understand materials.
Receive advice on healthy habits like eating a Mediterranean diet, improving sleep, and managing swallowing or memory issues.
Get support to connect with local activities and resources to reduce loneliness and stay active, such as community centers or fitness programs.
Have their medications reviewed by healthcare professionals to ensure they are appropriate and safe.
The program will be personalized based on each participant's needs. This study will provide valuable information on implementing practical programs that help older adults stay healthy and independent.
Read the detailed description
Population aging requires the implementation of sustained integrated strategies and programs to improve intrinsic capacity and delay disability in older adults. The +AGIL Barcelona program exemplifies a pragmatic, multicomponent intervention that effectively improves physical function by integrating health and community resources. This study aims to co-design, adapt, and scale up +AGIL to diverse socioeconomic areas in Barcelona, assessing its effectiveness and evaluating the process of progressive implementation.
Methods: Multicenter, pragmatic, Stepped-Wedge Cluster Randomized Trial, performed in three Primary Care Centers in Barcelona (PCCs), involving older adults screened as frail by the Gérontopôle Frailty Screening Tool (total sample size=396, 198 per arm). After a co-design phase to adapt the protocol to each local context, the intervention will be introduced sequentially at each site, according to a randomly determined schedule, until all PCCs are exposed. The intervention, previously piloted in a different PCC, is based on a Comprehensive Geriatric Assessment followed by a 10-week tailored boost multicomponent intervention aligned with the Integrated Care for Older People (ICOPE) framework of the World Health Organization - WHO - (physical exercise being the core element). After three months, continuity of activation is pursued through the integration of community resources (public or private gyms, civic centers etc). The primary outcome will be. The investigators designed a mixed-methods evaluation, measuring physical performance improvement using the Short Physical Performance Battery (SPPB) as the primary quantitative outcome, plus a qualitative assessment of participants' experience and program implementation.
Discussion: This study will provide relevant information on the implementation and impact of pragmatic, real-life interventions to improve intrinsic capacity and prevent disability in older adults.
- Conditions
- Frailty, Older Adults, Healthy Aging
- Being tested
- exercise promotion, review medication, promoting healthy aging, against social isolation
- Keywords
- frailty, older adults, Healthy Aging, integrated care, physical performance, intrinsic capacity
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise promotionBehavioural
- Up to 10 weekly 1-hour group sessions of multicomponent exercise guided by a physiotherapist, incorporating resistance, endurance, balance, and flexibility. Supported by materials adapted for low literacy or cognitive impairment, it empowers participants to maintain physical activity. Vivifrail may be used to prevent frailty and falls.
review medicationDrug
Also called person centered review medication
- Comprehensive medication review for optimization and deprescribing. Results show significant improvements in physical performance and intrinsic capacity at three and six months, sustained through empowerment and community resource connections.
promoting healthy agingBehavioural
- Non-pharmacological interventions, including nutritional guidance for a Mediterranean diet, dysphagia and cognitive impairment screening, and sleep hygiene counselling.
against social isolationOther
Support against social isolation by activating community resources.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | During the adaptation phase of the program, all participating centers will begin by recruiting participants to the control group until they are transitioned to the recruitment of the intervention group. The control group will receive standard care plus educational materials focused on promoting a healthy lifestyle (videos or written materials, along with a weekly phone call to encourage viewing or address any questions). This is to avoid a bias related to the potential benefits of stricter follow-up in the intervention arm. |
| Intervention | Experimental | The +AGIL program aligns with the World Health Organization's framework for Integrated Care for Older People (Ferrara MC et al., J Intern Med. 2023). It includes:
1. Up to 10 weekly 1-hour group exercise sessions led by a physiotherapist, focusing on resistance, endurance, balance, and flexibility. Materials are adapted for low literacy or cognitive impairment, and Vivifrail® may be used to prevent frailty and falls.
2. Non-pharmacological measures, such as guidance on the Mediterranean diet, screening for swallowing difficulties and cognitive decline, and advice on improving sleep.
3. Support to reduce social isolation by connecting participants with community resources.
4. A medication review to optimize treatments and deprescribe unnecessary drugs. The program has demonstrated significant improvements in physical performance and intrinsic capacity at three and six months, maintained through empowerment and ongoing connection to community resources. Receives: Behavioral: exercise promotion; Drug: review medication; Behavioral: promoting healthy aging; Other: against social isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance
measured using the Spanish-validated version of the Short Physical Performance Battery (SPPB). consistently with the previous demonstrator study, The SPPB includes sub-tests for balance, strength, and gait speed. Each sub-item is scored from 0 to 4 points, resulting in a maximum total score of 12, indicating optimal physical function. The SPPB is widely recognized as a predictor of disability in older adults. and serves as a primary indicator of frailty in this population. To assess the effectiveness of the +AGIL Barcelona program, we will use the total SPPB score and walking speed sub-item, which is also a strong predictor of adverse health outcomes in older populations.
Scores range from 0 (worse) to 12 (maximum), values under 10 indicates frailty.
Measured: baseline, 3 months and 6 months
Secondary outcomes (6)
Quality of life (QoL)
will be measured using the EQ-5D-5L tool, which consists of two components:
- Health state description comprising 5 dimensions that assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels: 1)No problems, 2) Slight problems, 3)Moderate problems, 4)Severe problems, and 5)Extreme problems
The responses create a five-digit health profile (e.g., 11111 represents perfect health). These profiles can be converted into a single utility score using country-specific value sets.
Maximum score (best health): 1.00 Minimum score (worst health): Typically less than 0 (values can go negative for states considered worse than death, depending on the value set used).
- a Visual Analog Scale for participants to provide an overall assessment of their health on a scale from 0 to 100.
Maximun score 100: Best imaginable health, Minimum score 0: Worst imaginable health
Measured: baseline, 3 months and 6 months
Cognitive impairment
will be screened using Mini-Cog®, a validated and quick tool that includes a 3-item recall test and a clock-drawing test. Scores range from 0 to 5 points, with a score below 3 indicating positive dementia screening.
Measured: baseline, 3 months and 6 months
Social engagement
will be measured using the 6-item Lubben Social Network Scale (LSNS-6), with scores ranging from 0 to 30 (higher scores indicate greater social engagement).
Measured: baseline, 3 months and 6 months
Adherence to the Mediterranean diet
will be assessed using the PREDIMED tool, whereas malnutrition risk will be measured using the MNA-Short Form (MNA-sf). An MNA-sf score of 12-14 points reflects normal nutritional status, 8-11 points suggests a risk of malnutrition, and 0-7 points suggest malnourishment.
Measured: baseline, 3 months and 6 months
Adverse events
These include falls, fractures, cardiovascular events (such as angina, myocardial infarction, TIA, and stroke), hospital admissions, and mortality.
Measured: baseline, 3 months and 6 months
The total number of medications
total number of medications, took from electronic health records and check it with participants and / or family
Measured: baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start2 Nov 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Sequential
- Model description
- Stepped-Wedge Cluster Randomized Trial
- Masking
- None (open label)
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc Sanitari Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia Baro, MD, Principal investigator, sbaro@perevirgili.cat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836167
- Sponsor's protocol ID
- +AGIL Barcelona
- Other IDs
- BDNS 604045
- Acronym
- +AGIL
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Inzitari M, Perez LM, Enfedaque MB, Soto L, Diaz F, Gual N, Martin E, Orfila F, Mulero P, Ruiz R, Cesari M. Integrated primary and geriatric care for frail older adults in the community: Implementation of a complex intervention into real life. Eur J Intern Med. 2018 Oct;56:57-63. doi: 10.1016/j.ejim.2018.07.022. Epub 2018 Aug 23.
PubMed 30145055Perez LM, Enfedaque-Montes MB, Cesari M, Soto-Bagaria L, Gual N, Burbano MP, Tarazona-Santabalbina FJ, Casas RM, Diaz F, Martin E, Gomez A, Orfila F, Inzitari M. A Community Program of Integrated Care for Frail Older Adults: +AGIL Barcelona. J Nutr Health Aging. 2019;23(8):710-716. doi: 10.1007/s12603-019-1244-4.
PubMed 31560028Ferrara MC, Perez LM, Sole AR, Villa-Garcia L, Ars J, Soto-Bagaria L, Bellelli G, Cesari M, Enfedaque MB, Inzitari M. Sustained improvement of intrinsic capacity in community-dwelling older adults: The +AGIL Barcelona multidomain program. J Intern Med. 2023 Dec;294(6):730-742. doi: 10.1111/joim.13710. Epub 2023 Aug 21.
PubMed 37574781Canet-Velez O, Solis-Navarro L, Sitja-Rabert M, Perez LM, Roca J, Soto-Bagaria L, Torres-Castro R, Diaz-Gallego F, Vilaro J, Inzitari M. Experience, facilitators, and barriers to the implementation of a multicomponent programme in older people living in the community, +AGIL Barcelona: A qualitative study. Front Public Health. 2023 Mar 30;11:1161883. doi: 10.3389/fpubh.2023.1161883. eCollection 2023.
PubMed 37064681Arnal C, Perez LM, Soto L, Herrero AC, Ars J, Baro S, Diaz F, Abilla A, Enfedaque MB, Cesari M, Inzitari M. Impact on physical function of the +AGIL Barcelona program in community-dwelling older adults with cognitive impairment: an interventional cohort study. BMC Geriatr. 2023 Nov 13;23(1):736. doi: 10.1186/s12877-023-04292-4.
PubMed 37957601
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- + AGIL Barcelona: Integrated Care for Community-Dwelling Frail Older Adults
- ClinicalTrials.gov ID
- NCT06836167
- Acronym / sponsor ID
- +AGIL / +AGIL Barcelona
- Conditions
- Frailty, Older Adults, Healthy Aging
- Keywords
- frailty, older adults, Healthy Aging, integrated care, physical performance, intrinsic capacity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Parc Sanitari Pere VirgiliUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 20 Feb 2025 (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.
The goal of this clinical trial is to evaluate the effectiveness of the +AGIL Barcelona program in helping older adults improve their physical abilities and delay disability. It will also explore how to adapt and expand the program to different neighborhoods in Barcelona. The main questions it aims to answer are:
Does the +AGIL program improve physical abilities, as measured by a simple physical performance test (SPPB)? How well can the program be adapted and implemented in different community health centers? Researchers will conduct the study in three community health centers in Barcelona, following a stepped approach to gradually introduce the program at each site.
Participants will:
Participate in up to 10 weekly group exercise sessions led by a physiotherapist. Focus on strength, balance, flexibility, and endurance. Exercises will be tailored to individual needs and supported with easy-to-understand materials.
Receive advice on healthy habits like eating a Mediterranean diet, improving sleep, and managing swallowing or memory issues.
Get support to connect with local activities and resources to reduce loneliness and stay active, such as community centers or fitness programs.
Have their medications reviewed by healthcare professionals to ensure they are appropriate and safe.
The program will be personalized based on each participant's needs. This study will provide valuable information on implementing practical programs that help older adults stay healthy and independent.
Detailed description
Population aging requires the implementation of sustained integrated strategies and programs to improve intrinsic capacity and delay disability in older adults. The +AGIL Barcelona program exemplifies a pragmatic, multicomponent intervention that effectively improves physical function by integrating health and community resources. This study aims to co-design, adapt, and scale up +AGIL to diverse socioeconomic areas in Barcelona, assessing its effectiveness and evaluating the process of progressive implementation.
Methods: Multicenter, pragmatic, Stepped-Wedge Cluster Randomized Trial, performed in three Primary Care Centers in Barcelona (PCCs), involving older adults screened as frail by the Gérontopôle Frailty Screening Tool (total sample size=396, 198 per arm). After a co-design phase to adapt the protocol to each local context, the intervention will be introduced sequentially at each site, according to a randomly determined schedule, until all PCCs are exposed. The intervention, previously piloted in a different PCC, is based on a Comprehensive Geriatric Assessment followed by a 10-week tailored boost multicomponent intervention aligned with the Integrated Care for Older People (ICOPE) framework of the World Health Organization - WHO - (physical exercise being the core element). After three months, continuity of activation is pursued through the integration of community resources (public or private gyms, civic centers etc). The primary outcome will be. The investigators designed a mixed-methods evaluation, measuring physical performance improvement using the Short Physical Performance Battery (SPPB) as the primary quantitative outcome, plus a qualitative assessment of participants' experience and program implementation.
Discussion: This study will provide relevant information on the implementation and impact of pragmatic, real-life interventions to improve intrinsic capacity and prevent disability in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-Wedge Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –During the adaptation phase of the program, all participating centers will begin by recruiting participants to the control group until they are transitioned to the recruitment of the intervention group. The control group will receive standard care plus educational materials focused on promoting a healthy lifestyle (videos or written materials, along with a weekly phone call to encourage viewing or address any questions). This is to avoid a bias related to the potential benefits of stricter follow-up in the intervention arm. |
| Intervention | Experimental | Behavioral: exercise promotion, Drug: review medication, Behavioral: promoting healthy aging, Other: against social isolationThe +AGIL program aligns with the World Health Organization's framework for Integrated Care for Older People (Ferrara MC et al., J Intern Med. 2023). It includes: 1. Up to 10 weekly 1-hour group exercise sessions led by a physiotherapist, focusing on resistance, endurance, balance, and flexibility. Materials are adapted for low literacy or cognitive impairment, and Vivifrail® may be used to prevent frailty and falls. 2. Non-pharmacological measures, such as guidance on the Mediterranean diet, screening for swallowing difficulties and cognitive decline, and advice on improving sleep. 3. Support to reduce social isolation by connecting participants with community resources. 4. A medication review to optimize treatments and deprescribe unnecessary drugs. The program has demonstrated significant improvements in physical performance and intrinsic capacity at three and six months, maintained through empowerment and ongoing connection to community resources. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- People aged 65 or older
- Presenting with suggestive signs of frailty according to the Gérontopôle Frailty Screening Test (GFST).
- Agree to participate and sign informed consent
Key exclusion criteria (1 listed)
- Requirement for hospital admission or an estimated life expectancy of less than one year.
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 |
|---|---|---|
| exercise promotiona) Up to 10 weekly 1-hour group sessions of multicomponent exercise guided by a physiotherapist, incorporating resistance, endurance, balance, and flexibility. Supported by materials adapted for low literacy or cognitive impairment, it empowers participants to maintain physical activity. Vivifrail may be used to prevent frailty and falls. | Behavioural | Intervention |
| review medicationAlso: person centered review medicationd) Comprehensive medication review for optimization and deprescribing. Results show significant improvements in physical performance and intrinsic capacity at three and six months, sustained through empowerment and community resource connections. | Drug | Intervention |
| promoting healthy agingb) Non-pharmacological interventions, including nutritional guidance for a Mediterranean diet, dysphagia and cognitive impairment screening, and sleep hygiene counselling. | Behavioural | Intervention |
| against social isolationSupport against social isolation by activating community resources. | Other | Intervention |
Primary outcome
Physical performance
Time frame: baseline, 3 months and 6 months
measured using the Spanish-validated version of the Short Physical Performance Battery (SPPB). consistently with the previous demonstrator study, The SPPB includes sub-tests for balance, strength, and gait speed. Each sub-item is scored from 0 to 4 points, resulting in a maximum total score of 12, indicating optimal physical function. The SPPB is widely recognized as a predictor of disability in older adults. and serves as a primary indicator of frailty in this population. To assess the effectiveness of the +AGIL Barcelona program, we will use the total SPPB score and walking speed sub-item, which is also a strong predictor of adverse health outcomes in older populations. Scores range from 0 (worse) to 12 (maximum), values under 10 indicates frailty.
6 secondary outcomes
Quality of life (QoL)
Time frame: baseline, 3 months and 6 months
Cognitive impairment
Time frame: baseline, 3 months and 6 months
Social engagement
Time frame: baseline, 3 months and 6 months
Adherence to the Mediterranean diet
Time frame: baseline, 3 months and 6 months
Adverse events
Time frame: baseline, 3 months and 6 months
The total number of medications
Time frame: baseline, 3 months and 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 20 Feb 2025.
- Background: PubMed 30145055Inzitari M, Perez LM, Enfedaque MB, Soto L, Diaz F, Gual N, Martin E, Orfila F, Mulero P, Ruiz R, Cesari M. Integrated primary and geriatric care for frail older adults in the community: Implementation of a complex intervention into real life. Eur J Intern Med. 2018 Oct;56:57-63. doi: 10.1016/j.ejim.2018.07.022. Epub 2018 Aug 23.
- Background: PubMed 31560028Perez LM, Enfedaque-Montes MB, Cesari M, Soto-Bagaria L, Gual N, Burbano MP, Tarazona-Santabalbina FJ, Casas RM, Diaz F, Martin E, Gomez A, Orfila F, Inzitari M. A Community Program of Integrated Care for Frail Older Adults: +AGIL Barcelona. J Nutr Health Aging. 2019;23(8):710-716. doi: 10.1007/s12603-019-1244-4.
- Background: PubMed 37574781Ferrara MC, Perez LM, Sole AR, Villa-Garcia L, Ars J, Soto-Bagaria L, Bellelli G, Cesari M, Enfedaque MB, Inzitari M. Sustained improvement of intrinsic capacity in community-dwelling older adults: The +AGIL Barcelona multidomain program. J Intern Med. 2023 Dec;294(6):730-742. doi: 10.1111/joim.13710. Epub 2023 Aug 21.
- Background: PubMed 37064681Canet-Velez O, Solis-Navarro L, Sitja-Rabert M, Perez LM, Roca J, Soto-Bagaria L, Torres-Castro R, Diaz-Gallego F, Vilaro J, Inzitari M. Experience, facilitators, and barriers to the implementation of a multicomponent programme in older people living in the community, +AGIL Barcelona: A qualitative study. Front Public Health. 2023 Mar 30;11:1161883. doi: 10.3389/fpubh.2023.1161883. eCollection 2023.
- Background: PubMed 37957601Arnal C, Perez LM, Soto L, Herrero AC, Ars J, Baro S, Diaz F, Abilla A, Enfedaque MB, Cesari M, Inzitari M. Impact on physical function of the +AGIL Barcelona program in community-dwelling older adults with cognitive impairment: an interventional cohort study. BMC Geriatr. 2023 Nov 13;23(1):736. doi: 10.1186/s12877-023-04292-4.
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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.
Sonia Baro, MD principal investigator
sbaro@perevirgili.cat
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise promotion, review medication and promoting healthy aging in people with Frailty and Older Adults, run by Parc Sanitari Pere Virgili at 3 sites in Spain.
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 3 inclusion and 1 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 Joan Sanabria (0034-932594000, jsanabria@perevirgili.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical performance (time frame: baseline, 3 months and 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 NCT06836167, which also lists 5 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 20 Feb 2025.