NCT Number: NCT06836167
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Barceloneta - Primary Care Center, Barcelona, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a) 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.
d) 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.
Other names: person centered review medication
b) Non-pharmacological interventions, including nutritional guidance for a Mediterranean diet, dysphagia and cognitive impairment screening, and sleep hygiene counselling.
Support against social isolation by activating community resources.
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.
Time frame: baseline, 3 months and 6 months
will be measured using the EQ-5D-5L tool, which consists of two components:
a) 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).
B) 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
Time frame: baseline, 3 months and 6 months
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.
Time frame: baseline, 3 months and 6 months
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).
Time frame: baseline, 3 months and 6 months
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.
Time frame: baseline, 3 months and 6 months
These include falls, fractures, cardiovascular events (such as angina, myocardial infarction, TIA, and stroke), hospital admissions, and mortality.
Time frame: baseline, 3 months and 6 months
total number of medications, took from electronic health records and check it with participants and / or family
Contact information is provided by the study sponsor or research team.
Aida Ribera, PhD
CONTACT
Joan Sanabria
CONTACT
Parc Sanitari Pere Virgili
Other
+ AGIL Barcelona: Integrated Care for Community-Dwelling Frail Older Adults
Acronym: +AGIL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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