FreeFrail Project: A Multicomponent Intervention for the Management of Frailty in Primary Care: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dual task exercise, Otago exercise.
- Who it may be relevant to
- Registry conditions: Frail Elderly, Dual Task Exercises in Elderly People, Exercise Training, Frailty. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
FreeFrail Project: Effectiveness of a Multicomponent Intervention Including Dual-task Exercise to Increase Functionality and Cognitive Performance in Frail and Pre-frail Individuals Over 65 Years Aged in Primary Care Compared to Usual Care: Protocol for a Randomized Controlled Trial
Overview
The primary aim is to assess the effectiveness of a multicomponent intervention including dual-task exercise in improving functionality and cognitive performance and in reducing frailty among community-dwelling adults aged ≥65 years compared to usual care. Secondary objectives include evaluating its impact on pain, anxiety or depression, sleep quality, quality of life, physical activity, handgrip strength, and polypharmacy. A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida. Frail older adults (≥65 years) will be recruited and randomly allocated to either the intervention group, receiving a structured cognitive-motor dual-task based multicomponent program, or the control group, receiving usual care. Outcomes will be assessed using validated tools at baseline and follow-up.
Interventions
- Behavioral Dual task exercise
The intervention group will conduct the same multicomponent intervention than the control group, but adding the dual cognitive task while performing the therapeutic physical activity, which may include counting numbers backwards, in 2s, mentioning names of animals, food, countries and others. The objective of this additional condition is to stimulate cognitive and functional capacity simultaneously, increasing the complexity of the activity and the transfer to daily life activities. - Behavioral Otago exercise
The proposed intervention is a multicomponent program designed to address frailty in community-dwelling older adults. It integrates three evidence-based domains: therapeutic physical activity, cognitive psychological intervention, and nutritional support.
Primary outcome measures
- Physical performance and functional status [Time frame: From enrollment to the end of treatment at 12 weeks]
- Cognitive function [Time frame: From enrollment to the end of treatment at 12 weeks]
- Frailty status [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (5)
- Quality of life / Anxiety and Depression / Pain severity [Time frame: From enrollment to the end of treatment at 12 weeks]
- Sleep performance [Time frame: From enrollment to the end of treatment at 12 weeks]
- Physical activity [Time frame: From enrollment to the end of treatment at 12 weeks]
- Handgrip strength [Time frame: From enrollment to the end of treatment at 12 weeks]
- Inflammatory and mitochondrial function biomarkers [Time frame: From enrollment to the end of treatment at 12 weeks]
Eligibility criteria
Inclusion criteria
- Aged 65 or older
- Frailty according to Fragil-VIG index (>0,20)
- Barthel index > 60
- Able to perform physical exercise
- Able to understand and communicate in Catalan or Spanish
Exclusion criteria
- Decompensated / Unstable cardiovascular disease or recent diagnosed
- Upper or lower injury with functional impairment
- Institutionalized patient.
- Terminal or tumoral processes
- People who participated in another clinical trial or exercise programme during last year
- Diagnosis of severe dementia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07205016 · FreeFrail Project