CClinicalTrials.gg
Status unknownNCT05232526Updated Feb 10, 2022

Imagery in Early Stages of Dementia

An interventional study of Mental imagery (MI) and exercise program and Mental Imagery and Exercise program in Mental Imagery and Dementia of Alzheimer Type, sponsored by University of West Attica. Status unknown at 1 site in Greece. Open to participants aged 65 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-10.

Sponsored by University of West Attica · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2021, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
65 Years to 95 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Mental Imagery
  • Dementia of Alzheimer Type

Keywords

  • Imagery
  • Exercise
  • Dementia
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's planned enrollment of 105 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

University of West Attica is the lead sponsor of 30 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Late stage of dementia
  • Psychiatric problems
  • Serious health problems
  • Not able to walk
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    Mental imagery (MI) and exercise program

    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).

    Other: Mental imagery (MI) and exercise program · Device: Mental Imagery and Exercise program

  • Placebo comparator
    Exercise program

    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).

    Other: Mental imagery (MI) and exercise program

Interventions

  • OtherMental imagery (MI) and exercise program

    Mental imagery and exercise program will be used to improve balance, functional status, cognitive ability, depression and quality of life of the sample

  • DeviceMental Imagery and Exercise program

    Questionnaires and functional tests are going to be used to evaluate balance, functional status, cognitive ability, depression and quality of life of the sample.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Prior to the 1st week of the program, the 12th week of the program

  2. 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.

    Time frame: Prior to the 1st week of the program, the 12th week of the program

  3. 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.

    Time frame: Prior to the 1st week of the program, the 12th week of the program

  4. 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.

    Time frame: Prior to the 1st week of the program, the 12th week of the program

Secondary outcomes

  1. 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.

    Time frame: Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program

  2. 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.

    Time frame: Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program

  3. 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).

    Time frame: Prior to the 6th week of the program, the 6th week of the program, the 12th week of the program

07

Study locations

1 of 1 sites recruiting
  • University of West Attica
    Athens, Aigaleo 12243, Greece
    • Anna Christakou, PhD · Contact · achristakou@uniwa.gr · +306977370284
    • Vasiliki Sakellari, Pr · Contact · vsakellari@uniwa.gr · +306979033952
    • Christina Mpouzineki · Sub investigator
    • Anna Christakou, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05232526
Lead sponsor
University of West Attica
Collaborators
Alzheimer's Association
Responsible party
Anna Christakou (Principal Investigator, University of West Attica) — Principal investigator
First posted
Feb 10, 2022
Start date
Oct 10, 2021
Primary completion
Jun 1, 2024 (estimated)
Completion
Oct 10, 2024 (estimated)
Last update
Feb 10, 2022

Study contacts

Anna Christakou, PhD
Contact
achristakou@uniwa.gr
+306977370284
Vasiliki Sakellari, Pr
Contact
vsakellari@uniwa.gr
+306979033952

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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