People With Subjective Cognitive Impairement (SCI)
Conditions
Brief summary
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.
Interventions
BEHAVIORALPhysical 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.
Sponsors
University Hospital of Patras
University Hospital of Crete
University of Patras
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balance | 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. |
| Upper limb muscle strength | 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). |
| Lower limb muscle strength | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function | Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months) | The International Physical Activity Questionnaire (IPAQ- 7) is used to evaluate physical function. IPAQ-7 is a 7-item questionnaire that calculates the physical activities taken place the last week (measured in METs). |
| Adherance to exercise | Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months) | The Exercise Adherance Rating Scale (EARS) is a validated and recently adapted into Greek outcome for measuring execise adhearance as well as the reasons of non-adhearing, comprising of 16 question items, exploring adhearance (6 question items) and reasons for adhearance/non-adhearance (10 items). Scores range from 0 (adherance) to 64 (non-adherance). |
| Fear of Falling | Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months) | The Greek version of the Falls Self-efficacy International Scale (FES-I\_GREEK) is used to evaluate Fear of Falling. FES-I is a 16-item questionnaire with scores ranging from 16 to 64 points. Higher scores indicate higher fear and concern regarding falls. |
Countries
Greece
Contacts
Primary ContactEvdokia Billis, PhD
Backup ContactEftychia Nastou, MSC
Outcome results
None listed