Imagery in Early Stages of Dementia

NCT ID: NCT05232526

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-10

Study Completion Date

2024-10-10

Brief Summary

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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

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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

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Mental Imagery Dementia of Alzheimer Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Mental imagery (MI) and exercise program

Intervention Type OTHER

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 program

Intervention Type DEVICE

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

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).

Group Type PLACEBO_COMPARATOR

Mental imagery (MI) and exercise program

Intervention Type OTHER

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

Interventions

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Mental 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

Intervention Type OTHER

Mental 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.

Intervention Type DEVICE

Eligibility Criteria

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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

* Late stage of dementia
* Psychiatric problems
* Serious health problems
* Not able to walk
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alzheimer's Association

OTHER

Sponsor Role collaborator

University of West Attica

OTHER

Sponsor Role lead

Responsible Party

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Anna Christakou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of West Attica

Athens, Aigaleo, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Anna Christakou, PhD

Role: CONTACT

+306977370284

Vasiliki Sakellari, Pr

Role: CONTACT

+306979033952

Facility Contacts

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Anna Christakou, PhD

Role: primary

+306977370284

Vasiliki Sakellari, Pr

Role: backup

+306979033952

References

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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.

Reference Type DERIVED
PMID: 36873828 (View on PubMed)

Other Identifiers

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93292 - 26/10/2021

Identifier Type: -

Identifier Source: org_study_id

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