An interventional study of Physical Activity in People With Subjective Cognitive Impairement (SCI), sponsored by University of Patras. Recruiting at 2 sites in Greece. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by University of Patras · Not applicable, Interventional, and Prevention
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 200 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Patras is the lead sponsor of 69 studies on the registry; 10 are open to participants now.
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Exclusion Criteri include people with:
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).
Behavioral: 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.
Balance
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.
Time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Upper limb muscle strength
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).
Time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Lower limb muscle strength
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).
Time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Aerobic capacity
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).
Time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Fear of Falling
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.
Time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Physical Function
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).
Time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Adherance to exercise
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).
Time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Plan to share: Undecided — Yes, once we gather 50% of the data, we will be happy to share.
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