FreeFrail Project: A Multicomponent Intervention for the Management of Frailty in Primary Care: A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversitat de Lleida

About this trial

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.

Eligibility criteria

Qualifiers

Aged 65 or older

Frailty according to Fragil-VIG index (>0,20)

Barthel index > 60

Able to perform physical exercise

Disqualifiers

Decompensated / Unstable cardiovascular disease or recent diagnosed

Upper or lower injury with functional impairment

Institutionalized patient.

Terminal or tumoral processes

Trial design

Treatments tested in this trial

  • Dual task exercise
  • Otago exercise

Treatment groups

220 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Universitat de Lleida

Lead sponsor

Institut Catala de Salut

Collaborator