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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Physical performance and functional status [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Cognitive function [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Frailty status [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (5)

• Quality of life / Anxiety and Depression / Pain severity [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Sleep performance [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Physical activity [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Handgrip strength [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Inflammatory and mitochondrial function biomarkers [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07205016 · FreeFrail Project

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗