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

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

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.

Study Overview

• Status: Recruiting
• Conditions: People With Subjective Cognitive Impairement (SCI)
• Intervention / Treatment: Behavioral: Physical Activity

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evdokia Billis, PhD; Phone Number: 00306973047170; Email: billis@upatras.gr
• Study Contact Backup: Name: Eftychia Nastou, MSC; Phone Number: 00306948694966; Email: nastou.e@upatras.gr

Study Locations

• Greece
  • Patra, Greece, 26504
    • Recruiting
    • Department of Psychiatry, School of Medicine, University of Patras
    • Contact: Panos Alexopoulos, PhD; Phone Number: 00306974072102; Email: panos.alexopoulos@upatras.gr
  • Achaia
    • Patra, Achaia, Greece, 26504
      • Recruiting
      • Laboratory of Clinical Physiotherapy and Research, Department of Physiotherapy, University of Patras
      • Contact: Evdokia Billis
      • Contact: Eftychia Nastou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
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.	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).	Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)

Collaborators and Investigators

• Sponsor: University of Patras
• Collaborators: University Hospital of Crete; University Hospital of Patras

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: GINGER_Physical Activity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Yes, once we gather 50% of the data, we will be happy to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No