People With Subjective Cognitive Impairement (SCI)GINGERNCT06528379
Physical Activity Component of the Greek Interventional Geriatric Study to Prevent Cognitive Impairment and Disability (GINGER)
A study testing Physical Activity in people with People With Subjective Cognitive Impairement (SCI), run by University of Patras at 2 sites in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- People With Subjective Cognitive Impairement (SCI)
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesGreece
- Study dates
- 20 May 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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. )
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
Laboratory of Clinical Physiotherapy and Research, Department of Physiotherapy, University of Patras
Pátrai, Achaia, 26504
Evdokia Billis
Eftychia Nastou
- Recruiting
Department of Psychiatry, School of Medicine, University of Patras
Pátrai, 26504
Panos Alexopoulos, PhD, 00306974072102, panos.alexopoulos@upatras.gr
About this study
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
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.
- Being tested
- Physical Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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).
Measured: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start20 May 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for People With Subjective Cognitive Impairement (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Patras, University Hospital of Crete
- Responsible party
- Principal investigator, Evdokia Billis, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528379
- Sponsor's protocol ID
- GINGER_Physical Activity
- Acronym
- GINGER
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes, once we gather 50% of the data, we will be happy to share.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06528379
- Acronym / sponsor ID
- GINGER / GINGER_Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Collaborators
- University Hospital of Patras, University Hospital of Crete
- Study start
- 20 May 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity intervention | Experimental | Behavioral: Physical ActivityThis 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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. )
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityThe 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. | Behavioural | Physical Activity intervention |
Primary outcome
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.
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).
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).
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).
3 secondary outcomes
Fear of Falling
Time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Physical Function
Time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Adherance to exercise
Time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: Undecided. Yes, once we gather 50% of the data, we will be happy to share.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with People With Subjective Cognitive Impairement (SCI), run by University of Patras at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evdokia Billis, PhD (00306973047170, billis@upatras.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Baseline, midway (12-weeks), post-intervention (6months) & follow-up (3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.