NCT05232526

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

2.6 years

First QC Date

January 13, 2022

Last Update Submit

January 31, 2022

Conditions

Mental ImageryDementia of Alzheimer Type

Keywords

ImageryExerciseDementia

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Prior to the 1st week of the program, the 12th week of the program

Secondary Outcomes (3)

  • Cognitive ability

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

  • Depression

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

  • Quality of life

    Prior to the 6th week of the program, the 6th week of the program, the 12th week of the program

Study Arms (2)

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).

Other: Mental imagery (MI) and exercise programDevice: 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).

Other: Mental imagery (MI) and exercise program

Interventions

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

Exercise programMental imagery (MI) and exercise program
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.

Mental imagery (MI) and exercise program

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of West Attica

Athens, Aigaleo, 12243, Greece

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36873828DERIVED

MeSH Terms

Conditions

Motor ActivityDementia

Condition Hierarchy (Ancestors)

BehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Anna Christakou, PhD

CONTACT

+306977370284achristakou@uniwa.gr

Vasiliki Sakellari, Pr

CONTACT

+306979033952vsakellari@uniwa.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 10, 2022

Study Start

October 10, 2021

Primary Completion

June 1, 2024

Study Completion

October 10, 2024

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)