Mental ImageryNCT05232526
Imagery in Early Stages of Dementia
A study testing Mental imagery (MI) and exercise program and Mental Imagery and Exercise program in people with Mental Imagery and Dementia of Alzheimer Type, run by University of West Attica at 1 site in Greece.
Trial summary
The purpose of the present study is to investigate the effectiveness of mental imagery (MI) in subjects with early stage of dementia. The hypothesis of the study is that MI will have a beneficial effect in motor, cognitive and emotional state in this clinical population. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Imagery, Dementia of Alzheimer Type
- What is being tested?
- Mental imagery (MI) and exercise program and Mental Imagery and Exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteGreece
- Study dates
- 10 Oct 2021to 10 Oct 2024
- 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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 95 years<age>65 years
- Diagnosed early stage of dementia
- Good oral and written speech and to perform orders
- Both sexes
- Ambulatory
- No other health issues in the last month
Who cannot join
- Late stage of dementia
- Psychiatric problems
- Serious health problems
- Not able to walk
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University of West Attica
Athens, Aigaleo, 12243
Anna Christakou, PhD, +306977370284, achristakou@uniwa.gr
Vasiliki Sakellari, Pr, +306979033952, vsakellari@uniwa.gr
About this study
Official title: The Effectiveness of Mental Imagery in Motor and Cognitive Rehabilitation in Subjects of Early Stage of Dementia
The purpose of the present study is to investigate the effectiveness of mental imagery (MI) in subjects with early stage of dementia. The hypothesis of the study is that MI will have a beneficial effect in motor, cognitive and emotional state in this clinical population.
Read the detailed description
Dementia is a disorder that is characterized by a decline in cognition involving one or more cognitive domains (learning and memory, language, executive function, complex attention, perceptual-motor, social cognition). The most common form of dementia in older adults is Alzheimer disease (AD), accounting for 60 to 80 percent of cases.
Mental imagery (MI) is a technique which involves envisioning motor actions without actual execution. MI is considered an effective rehabilitative tool in athletes, Parkinson's disease, and post stroke because it engages the same or similar neural systems as the actual execution of motor actions to improve gait, gait-related, and cognitive functions having as a result improvements in gait speed, stride length, tandem stance, timed up and go, clock drawing and stroop interference.
The recruitment of the population will be carried out by Day Care Centers in Athens Alzheimer Association. A group of elderly patients with early stage of dementia, aged 65 to 95 years, will participate. Information sheet and consent form will be provided to all participants. A randomized intervention study is designed to assess the efficacy of MI as therapeutic strategy for subjects with early stage of dementia and the sample will be randomized to one of the three following study groups: 1. MI and exercise program (intervention group) 2. Only exercise program (control group) 3. Neither MI nor exercise program (2nd control group). Assessment will be obtained in three-time periods: prior to the program, middle of the program and after the program.
- Conditions
- Mental Imagery, Dementia of Alzheimer Type
- Being tested
- Mental imagery (MI) and exercise program, Mental Imagery and Exercise program
- Keywords
- Imagery, Exercise, Dementia
- Medical subject headings
- Motor Activity, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental imagery (MI) and exercise programOther
Mental imagery and exercise program will be used to improve balance, functional status, cognitive ability, depression and quality of life of the sample
Mental Imagery and Exercise programDevice
Questionnaires and functional tests are going to be used to evaluate balance, functional status, cognitive ability, depression and quality of life of the sample.
| Study group | Role | What they receive |
|---|---|---|
| Mental imagery (MI) and exercise program | Experimental | MI will start immediately when the sample is going to start the exercise program. The intervention group will undergo 24 sessions of imagery, starting from the 1st exercise program session. Participants of the intervention group will undergo a 45-minute imagery session sitting in a quiet place after the end of every exercise program session. The content of every imagery session is alike with the content of the exercise program session. That means that every session includes imagery of the same exercises of the exercise program performed earlier by the subject in the Day Center. Sessions are identical for all subjects of the intervention group. The total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks). Receives: Other: Mental imagery (MI) and exercise program; Device: Mental Imagery and Exercise program |
| Exercise program | Placebo comparator | The total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks). Receives: Other: Mental imagery (MI) and exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is being assessed (Change from Baseline Balance at 12 weeks)
The Berg Balance Scale (BBS) is used to objectively determine a subject's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a 5-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Measured: Prior to the 1st week of the program, the 12th week of the program
Change is being assessed (Change from Baseline Stability at 12 weeks)
The Multidirectional Reach Test (Reach in Four Directions Test) is a screening tool to determine the limits of stability of subjects in 4 directions: forward, backward, leftward and rightward. Subjects performed maximal outstretched arm reach in each direction with their feet flat on the floor.
Measured: Prior to the 1st week of the program, the 12th week of the program
Change is being assessed (Change from Baseline Siti-to-stand ability at 12weeks)
The Five Times Sit-to-Stand Test (FTSST) is considered to be a useful, consistent and low-cost tool to assess sit-to-stand ability. The FTSST measures the time taken to stand five times from a sitting position as quickly as possible that measures of lower limb strength, balance control and exercise capacity.
Measured: Prior to the 1st week of the program, the 12th week of the program
Change is being assessed (Change from Baseline Functional status at 12 weeks)
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility. It measures the time that a subject takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Measured: Prior to the 1st week of the program, the 12th week of the program
Secondary outcomes (3)
Cognitive ability
The Walking While Talking Test (WWITT) is a dual-task measure to examine cognitive-motor interactions. During the WWTT, subjects walk at self-paced speed for 6 meters before turning and walking back to the starting point. During the walking subjects recite 12 Greek alphabet letters (each letter at each step) starting with "A" (ΑΒΓΔ, ΚΛΜΝ, ΠΡΣΤ) until the starting point. Time and errors in the alphabet will be recorded.
Measured: Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program
Depression
The Short-Form of Geriatric Depression Scale (SF-GDS) is a 15-question screening tool for depression in older adults, using a "Yes/No" format. It takes 5-7 minutes to complete and is filled out by the researcher with minimal training in its use.
Measured: Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program
Quality of life
The Euro-Qol 5 Dimensions 5 Level of severity scale (Euro-Qol 5D-5L scale) is a preference-based Health Related Quality of Life measure which includes 5 domains, i.e., mobility, self-care, usual activities, pain/discomfort, anxiety/depression. The core of all domains ranges from 1 (best score) up to 5 (worse score). The total perceived quality of life will be graded by the patient. Also it includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Measured: Prior to the 6th week of the program, the 6th week of the program, the 12th week of the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start10 Oct 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental ImageryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Anna Christakou, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232526
- Sponsor's protocol ID
- 93292 - 26/10/2021
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christakou A, Bouzineki C, Pavlou M, Stranjalis G, Sakellari V. The effectiveness of mental imagery on motor, cognitive and emotional status of older people with early-stage dementia: A study protocol. J Frailty Sarcopenia Falls. 2023 Mar 1;8(1):60-65. doi: 10.22540/JFSF-08-060. eCollection 2023 Mar.
PubMed 36873828
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Mental Imagery in Motor and Cognitive Rehabilitation in Subjects of Early Stage of Dementia
- ClinicalTrials.gov ID
- NCT05232526
- Acronym / sponsor ID
- 93292 - 26/10/2021
- Conditions
- Mental Imagery, Dementia of Alzheimer Type
- Keywords
- Imagery, Exercise, Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 10 Feb 2022 (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 purpose of the present study is to investigate the effectiveness of mental imagery (MI) in subjects with early stage of dementia. The hypothesis of the study is that MI will have a beneficial effect in motor, cognitive and emotional state in this clinical population.
Detailed description
Dementia is a disorder that is characterized by a decline in cognition involving one or more cognitive domains (learning and memory, language, executive function, complex attention, perceptual-motor, social cognition). The most common form of dementia in older adults is Alzheimer disease (AD), accounting for 60 to 80 percent of cases.
Mental imagery (MI) is a technique which involves envisioning motor actions without actual execution. MI is considered an effective rehabilitative tool in athletes, Parkinson's disease, and post stroke because it engages the same or similar neural systems as the actual execution of motor actions to improve gait, gait-related, and cognitive functions having as a result improvements in gait speed, stride length, tandem stance, timed up and go, clock drawing and stroop interference.
The recruitment of the population will be carried out by Day Care Centers in Athens Alzheimer Association. A group of elderly patients with early stage of dementia, aged 65 to 95 years, will participate. Information sheet and consent form will be provided to all participants. A randomized intervention study is designed to assess the efficacy of MI as therapeutic strategy for subjects with early stage of dementia and the sample will be randomized to one of the three following study groups: 1. MI and exercise program (intervention group) 2. Only exercise program (control group) 3. Neither MI nor exercise program (2nd control group). Assessment will be obtained in three-time periods: prior to the program, middle of the program and after the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental imagery (MI) and exercise program | Experimental | Other: Mental imagery (MI) and exercise program, Device: Mental Imagery and Exercise programMI will start immediately when the sample is going to start the exercise program. The intervention group will undergo 24 sessions of imagery, starting from the 1st exercise program session. Participants of the intervention group will undergo a 45-minute imagery session sitting in a quiet place after the end of every exercise program session. The content of every imagery session is alike with the content of the exercise program session. That means that every session includes imagery of the same exercises of the exercise program performed earlier by the subject in the Day Center. Sessions are identical for all subjects of the intervention group. The total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks). |
| Exercise program | Placebo comparator | Other: Mental imagery (MI) and exercise programThe total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks). |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 95 years<age>65 years
- Diagnosed early stage of dementia
- Good oral and written speech and to perform orders
- Both sexes
- Ambulatory
Key exclusion criteria (4 listed)
- Late stage of dementia
- Psychiatric problems
- Serious health problems
- Not able to walk
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 |
|---|---|---|
| Mental imagery (MI) and exercise programMental imagery and exercise program will be used to improve balance, functional status, cognitive ability, depression and quality of life of the sample | Other | Exercise program, Mental imagery (MI) and exercise program |
| Mental Imagery and Exercise programQuestionnaires and functional tests are going to be used to evaluate balance, functional status, cognitive ability, depression and quality of life of the sample. | Device | Mental imagery (MI) and exercise program |
Primary outcome
Change is being assessed (Change from Baseline Balance at 12 weeks)
Time frame: Prior to the 1st week of the program, the 12th week of the program
The Berg Balance Scale (BBS) is used to objectively determine a subject's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a 5-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Change is being assessed (Change from Baseline Stability at 12 weeks)
Time frame: Prior to the 1st week of the program, the 12th week of the program
The Multidirectional Reach Test (Reach in Four Directions Test) is a screening tool to determine the limits of stability of subjects in 4 directions: forward, backward, leftward and rightward. Subjects performed maximal outstretched arm reach in each direction with their feet flat on the floor.
Change is being assessed (Change from Baseline Siti-to-stand ability at 12weeks)
Time frame: Prior to the 1st week of the program, the 12th week of the program
The Five Times Sit-to-Stand Test (FTSST) is considered to be a useful, consistent and low-cost tool to assess sit-to-stand ability. The FTSST measures the time taken to stand five times from a sitting position as quickly as possible that measures of lower limb strength, balance control and exercise capacity.
Change is being assessed (Change from Baseline Functional status at 12 weeks)
Time frame: Prior to the 1st week of the program, the 12th week of the program
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility. It measures the time that a subject takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
3 secondary outcomes
Cognitive ability
Time frame: Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program
Depression
Time frame: Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program
Quality of life
Time frame: Prior to the 6th week of the program, the 6th week of the program, the 12th week of the program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Derived from this study: PubMed 36873828Christakou A, Bouzineki C, Pavlou M, Stranjalis G, Sakellari V. The effectiveness of mental imagery on motor, cognitive and emotional status of older people with early-stage dementia: A study protocol. J Frailty Sarcopenia Falls. 2023 Mar 1;8(1):60-65. doi: 10.22540/JFSF-08-060. eCollection 2023 Mar.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental imagery (MI) and exercise program and Mental Imagery and Exercise program in people with Mental Imagery and Dementia of Alzheimer Type, run by University of West Attica at 1 site 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 6 inclusion and 4 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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Anna Christakou, PhD (+306977370284, achristakou@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change is being assessed (Change from Baseline Balance at 12 weeks) (time frame: Prior to the 1st week of the program, the 12th week of the program). 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?
On the ClinicalTrials.gov record for NCT05232526, which also lists 1 linked publication.
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 10 Feb 2022.