+AGIL Barcelona: Integrated Care for Community-Dwelling Frail Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorParc Sanitari Pere Virgili
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Requirement for hospital admission or an estimated life expectancy of less than one year.
Trial design
Design model
Sequential
Treatments tested in this trial
exercise promotion
Behaviorala) 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 medication
Drugd) 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 aging
Behavioralb) Non-pharmacological interventions, including nutritional guidance for a Mediterranean diet, dysphagia and cognitive impairment screening, and sleep hygiene counselling.
against social isolation
Other interventionSupport against social isolation by activating community resources.
Treatment groups
396 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline, 3 months and 6 monthsSecondary outcomes
1
Quality of life (QoL)
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 months2
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.
Time frame
baseline, 3 months and 6 months3
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).
Time frame
baseline, 3 months and 6 months4
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.
Time frame
baseline, 3 months and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov