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

U

University of Patras

Status

Enrolling

Conditions

People With Subjective Cognitive Impairement (SCI)

Treatments

Behavioral: Physical Activity

Study type

Interventional

Funder types

Other

Identifiers

NCT06528379
GINGER_Physical Activity

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

Physical Activity intervention
Experimental group
Description:
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).
Treatment:
Behavioral: Physical Activity

Trial contacts and locations

2

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Central trial contact

Evdokia Billis, PhD; Eftychia Nastou, MSC

Data sourced from clinicaltrials.gov

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