Clinical trial NCT06528379: Physical Activity Component of the Greek Interventional Geriatric Study to Prevent Cognitive Impairment and Disability (GINGER)
Official title: Physical Activity Component of the Greek Interventional Geriatric Study to Prevent Cognitive Impairment and Disability (GINGER): Study Protocol and Feasibility of the Assessment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: People With Subjective Cognitive Impairement (SCI)
Lead sponsor: University of Patras
Sponsor class: OTHER
Collaborators: name: University Hospital of Patras
name: University Hospital of Crete
First posted: 2024-07-30
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Balance
timeFrame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
measure: Upper limb muscle strength
timeFrame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
measure: Lower limb muscle strength
timeFrame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
measure: Aerobic capacity
timeFrame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Secondary outcomes:
measure: Fear of Falling
timeFrame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
measure: Physical Function
timeFrame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
measure: Adherance to exercise
timeFrame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Other outcomes:
Locations:
city: Patra
country: Greece
facility: Laboratory of Clinical Physiotherapy and Research, Department of Physiotherapy, University of Patras
state: Achaia
city: Patra
country: Greece
facility: Department of Psychiatry, School of Medicine, University of Patras
Study officials:
References: