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NCT Number: NCT06528379

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Clinical Physiotherapy and Research, Department of Physiotherapy, University of Patras, Pátrai, Achaia, Greece

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Balance

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

    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.

  2. Upper limb muscle strength

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

    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).

  3. Lower limb muscle strength

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

    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).

  4. Aerobic capacity

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

    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).

Secondary outcomes

  1. Fear of Falling

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

    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.

  2. Physical Function

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

    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).

  3. Adherance to exercise

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eftychia Nastou, MSC

CONTACT

[email protected]

00306948694966

Evdokia Billis, PhD

CONTACT

[email protected]

00306973047170

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Collaborators

  • University Hospital of Crete
  • University Hospital of Patras

Registry information

Official study title

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

Acronym: GINGER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.