Physical Activity Component of the Greek Interventional Geriatric Study to Prevent Cognitive Impairment and Disability (GINGER): Study Protocol and Feasibility of the Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Upper limb muscle strength
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Physical Activity intervention
This Physical Activity intervention arm is a 6-month excercise protocol for SCI people, delivered 3 times per week, comprising of 2 supervised group-based exercise sessions & one home-based (unsupervised) one.
The exercise programme is a progressive evidence-based tailored exercise regime comprising aerobic, resistance and balance exercises, applied at a moderate intensity (60-80% of targeted heart rate).
干预措施: Physical Activity (Behavioral)
结局指标
主要结局
Upper limb muscle strength
时间窗: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
The Hand Grip Strength test is an objective, established and standardised measure of upper limb muscle strength, comprising a standard electronic hand dynamometer (Jamar) for measuring muscle strength of the hand (measured in kgs).
Balance
时间窗: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
The Greek version of the Mini-BESTest (Mini-Balance Evaluation Systems Test) is used to assess the balance of each participant comprising four primary assessment balance categories (anticipatory, reactive postural control, sensory orientation, dynamic gait). The Mini-BESTest focuses primarily on dynamic balance and contains 14 different balancing tasks, each scored from 0 (lowest level of function) to 2 (highest level of function). Thus, overall scores range from 0 (lowest level of function) to 28 (highest level of function) and subsequent subscales are scored as: Anticipatory tasts (0-6), Reactive Postural Control (0-6), Sensory Orientation (0-6) \& Dynamic Gait (0-10). Mini-BESTest takes about 10-15 minutes to be administered.
Lower limb muscle strength
时间窗: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
The lower limbs strength is measured using the 30 seconds Sit-to-Stand test, which is an objective, established and standardised measure of lower limb muscle strength. Participants are seated in the front part of a standard chair with their hands crossed in front of their chest, and they are asked to stand up completely (full extension of their knees) and sit back down to the chair as many times as possible during 30 seconds (measuring the repetitions).
Aerobic capacity
时间窗: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
The 2 Minute Walk Test is an established and objective test for measuring aerobic capacity. Participants are placed in a hallway of nine meters and are asked to cover as much ground as they can in two minutes (measured in meters).
次要结局
- Fear of Falling(Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months))
- Physical Function(Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months))
- Adherance to exercise(Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months))
研究者
Evdokia Billis
Professor in Physiotherapy
University of Patras