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

NCT06528379 | Recruiting

• 1 other identifier: GINGER_Physical Activity
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

People With Subjective Cognitive Impairement (SCI)

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

Secondary Outcomes (3)

• Fear of Falling

  Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)

• Physical Function

  Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)

• Adherance to exercise

  Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)

Study Arms (1)

Physical Activity intervention

EXPERIMENTAL

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

Interventions

Physical Activity BEHAVIORAL

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.

Physical Activity intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. )
• 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

Sponsors & Collaborators

• University of Patras: lead
• University Hospital of Patras: collaborator
• University Hospital of Crete: collaborator

Study Sites (2)

Laboratory of Clinical Physiotherapy and Research, Department of Physiotherapy, University of Patras

Pátrai, Achaia, 26504, Greece

RECRUITING

Department of Psychiatry, School of Medicine, University of Patras

Pátrai, 26504, Greece

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Evdokia Billis, PhD

CONTACT

00306973047170; billis@upatras.gr

Eftychia Nastou, MSC

CONTACT

00306948694966; nastou.e@upatras.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Physiotherapy

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

GR (2)