Physical Activity Component of the Greek Interventional Geriatric Study to Prevent Cognitive Impairment and Disability (GINGER)

Официальное название

Physical Activity Component of the Greek Interventional Geriatric Study to Prevent Cognitive Impairment and Disability (GINGER): Study Protocol and Feasibility of the Assessment

Обзор

The Greek Interventional Geriatric Study to Prevent Cognitive Impairment and Disability (GINGER) is a six-month multimodal, multicenter study aimed at people with Subjective Cognitive Impairement (SCI). One of the GINGER's interventional components is the Physcial Activity (PA) component, coordinated by the University of Patras. This PA component's scope is to determine whether an enhanced individualized physical exercise intervention programme can improve cognitive changes, physical function, quality of life and wellbeing in people with subjective cognitive decline.

Вмешательства

• Поведенческое Physical Activity
  The exercise programme is a 6-month progressive tailored-based exercise regime comprising * aerobic exercises (40-60%) * resistance exercises (20-40%) * balance with resistance exercises (20%) . This is peformed 3 times weekly, it is tailored to each individual but delivered in a small group-based manner. Two sessions are supervised by physiotherapist /exercise scientist and one session is unsupervised, home-based.

Первичные конечные точки

• Balance [Срок оценки: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)]
• Upper limb muscle strength [Срок оценки: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)]
• Lower limb muscle strength [Срок оценки: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)]
• Aerobic capacity [Срок оценки: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)]

Вторичные конечные точки (3)

• Fear of Falling [Срок оценки: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)]
• Physical Function [Срок оценки: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)]
• Adherance to exercise [Срок оценки: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)]

Критерии участия

Inclusion Criteria include people with:

• Subjective Cognitive Decline confirmed from the Subjctive Cognitive Decline Questionnaire (SCD - Q score >7)
• Absence of objective cognitive imparement as confirmed from cognitive assessment tests (i.e. MoCA, Trail A \& B, Stroop, RCFT, FAS. )

Exclusion Criteri include people with:

• Mild Cognitive Impairement (MCI) or dementia
• Chronic psychiatric or neurological disorders affecting cognition (i.e. bipolar disorder, schizophrenia, MS, TBI, Parkinson's disease etc.)
• Unstable pathological diseases (i.e. uncontrolled hypothyrodism, athythmias, uncontrolled hypertension, high blood pressure at rest etc.)
• Recent (<6 month) surgery, which restrics active participation in exercise/physical activity
• inadequate knowledge of Greek

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Греция · 2 центра

• Laboratory of Clinical Physiotherapy and Research, Department of Physiotherapy, University — Pátrai
• Department of Psychiatry, School of Medicine, University of Patras — Pátrai

Идентификаторы

NCT: NCT06528379 · GINGER_Physical Activity

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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