Back to resultsEffects of Dual-Task Training In Individuals With Alzheimer
Primary Purpose
Alzheimer Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dual-Task Training
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer, Fear of falling, Dual-task, Balance, Cognition
Eligibility Criteria
Inclusion Criteria: having been diagnosed with mild or moderate Alzheimer's disease able to walk with or without assistance having sufficient visual and auditory ability to perform the cognitive tests being fit to perform physical exercises being able to participate in proposed interventions and assessments Exclusion Criteria: having a neurological disorder other than Alzheimer having any musculoskeletal problems that can affect balance having any contraindication to exercise functional limitation or sensory impairment that may affect performance major depression
Sites / Locations
- Karsiyaka Municipality Day Living Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Dual-Task Training Group
Arm Description
Participants in control group will receive an exercise program consisted of upper and lower range of motion exercises.The exercises will be started as 8-10 repetitions and 1 set and the number of sets will be increased according to the progression of the patient. Exercises will be applied for 8 weeks, 2 days a week, each session will last for 30 minutes.
Participants in the dual-task training group will receive exercises involving both motor and cognitive functions.Dual-task training sessions will begin with 10 minutes of stretching and proceed with 20 minutes of motor-cognitive dual-task exercises (counting backwards from 30 on double stance, naming the months and singing when standing on soft surfaces, finding words that starts with a given letter etc.) and sessions will end with 10 minutes of cooling.Exercises will be applied for 8 weeks 2 days a week each session will last for 30 minutes.
Outcomes
Primary Outcome Measures
Timed Up And Go(TUG)
It is a frequently used test that evaluates functional mobility and dynamic balance. At the beginning of the test, individuals sit in a chair. A distance of 3 m is set in front of the patient. With the start command, the patient gets up from his seat and walks 3 m, turns around and walks back and sits. With the start command, the time until the moment of sitting on the chair is recorded in seconds.Shorter duration indicates better functional mobility.
5 Times Sit To Stand Test(5XSST)
5XSST evaluates lower extremity functional strength, transitional movements, balance and fall risk. The time it takes for the participant to sit and get up from a chair 5 times is recorded in seconds. Interpretations are made about balance and fall risk by comparing the norm times for age with the time the individual completes the test.
Cognitive Reserve Index Questionaire(CRIq)
CRIq assesses an individual's cognitive reserve through compiling information about their entire adult life. If the participant has a suspected or confirmed cognitive weakness, the questionnaire must be answered by a family member or caregiver. The total score is obtained by recording the frequency of the individual's educational life, work and leisure activities in years. According to the score, the participant's cognitive reserve is interpreted as low, low - medium, medium, medium - high or high
Quality of Life in Alzheimer's Disease(QOL-AD)
There are two versions of the scale: patient and family member/caregiver. In order to maximize construct validity, the scale is filled in independently by both patients and caregivers. It consists of questions asked about different aspects of life in order to determine the quality of life of the person. For each question, they are asked to choose the most appropriate one from the Poor, Fair, Good or Excellent answers.Higher scores indicate better quality of life.
Geriatric Depression Scale(GDS)
The scale consists of 30 questions questioning how the participant felt in the past week. The person is asked to give the appropriate Yes(0) or No(1) answer to each question.Scores higher than 5 indicate depression.
Secondary Outcome Measures
Dual-Task Questionnaire(DTQ)
The Dual Task Questionnaire assesses the frequency of difficulties experienced by individuals with neurological injury or disease during activities of daily living that involve dual tasks. DTQ is scored between 0-40. Higher scores indicate more frequent dual-task difficulties.
Modified Falling Efficacy Scale(MFES)
The scale consists of 14 items. On a scale of 0 to 10 (on the scale), the participant asked how safe they feel doing each of these activities without falling, with 0 being "not safe/not sure", 5 "quite safe/quite confident", and 10 "completely safe/ are asked to rate it in terms of being completely sure.
Mini Mental Test(MMT)
Scoring is made between 0-30 on the scale in which the sub-headings of orientation, recording memory, attention and calculation, recall, language are evaluated.Lesser scores indicate worse cognitive function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05765552
Brief Title
Effects of Dual-Task Training In Individuals With Alzheimer
Official Title
Effects Of Dual-Task Training On Balance, Fear Of Falling,Cognitive Functions, Dual-Task Performance, Depression And Quality Of Life In Individuals With Alzheimer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effects of dual-task training on balance, fear of falling, cognitive functions, dual-task performance, depression and quality of life in individuals with Alzheimer.
Detailed Description
Eligible participants will be randomized to control or dual-task training group.Control group will receive conventional therapy generally consisted of lower and upper range of motion exercises for 30 minutes 2 times a week for 8 weeks.Dual-task training group will receive exercises involving motor-cognitive dual-task exercises for 30 minutes 2 times a week for 8 weeks.Each participant will be assessed before and after the 8 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer, Fear of falling, Dual-task, Balance, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants in control group will receive an exercise program consisted of upper and lower range of motion exercises.The exercises will be started as 8-10 repetitions and 1 set and the number of sets will be increased according to the progression of the patient. Exercises will be applied for 8 weeks, 2 days a week, each session will last for 30 minutes.
Arm Title
Dual-Task Training Group
Arm Type
Experimental
Arm Description
Participants in the dual-task training group will receive exercises involving both motor and cognitive functions.Dual-task training sessions will begin with 10 minutes of stretching and proceed with 20 minutes of motor-cognitive dual-task exercises (counting backwards from 30 on double stance, naming the months and singing when standing on soft surfaces, finding words that starts with a given letter etc.) and sessions will end with 10 minutes of cooling.Exercises will be applied for 8 weeks 2 days a week each session will last for 30 minutes.
Intervention Type
Other
Intervention Name(s)
Dual-Task Training
Intervention Description
Motor-cognitive dual-task exercises will be applied for 2 days a week for 8 weeks.Sessions will last for 30 minutes.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Upper and lower extremity range of motion exercises will be applied for 8-10 repetitions for 1 set 2 times a week for 8 weeks.
Primary Outcome Measure Information:
Title
Timed Up And Go(TUG)
Description
It is a frequently used test that evaluates functional mobility and dynamic balance. At the beginning of the test, individuals sit in a chair. A distance of 3 m is set in front of the patient. With the start command, the patient gets up from his seat and walks 3 m, turns around and walks back and sits. With the start command, the time until the moment of sitting on the chair is recorded in seconds.Shorter duration indicates better functional mobility.
Time Frame
eight weeks
Title
5 Times Sit To Stand Test(5XSST)
Description
5XSST evaluates lower extremity functional strength, transitional movements, balance and fall risk. The time it takes for the participant to sit and get up from a chair 5 times is recorded in seconds. Interpretations are made about balance and fall risk by comparing the norm times for age with the time the individual completes the test.
Time Frame
eight weeks
Title
Cognitive Reserve Index Questionaire(CRIq)
Description
CRIq assesses an individual's cognitive reserve through compiling information about their entire adult life. If the participant has a suspected or confirmed cognitive weakness, the questionnaire must be answered by a family member or caregiver. The total score is obtained by recording the frequency of the individual's educational life, work and leisure activities in years. According to the score, the participant's cognitive reserve is interpreted as low, low - medium, medium, medium - high or high
Time Frame
eight weeks
Title
Quality of Life in Alzheimer's Disease(QOL-AD)
Description
There are two versions of the scale: patient and family member/caregiver. In order to maximize construct validity, the scale is filled in independently by both patients and caregivers. It consists of questions asked about different aspects of life in order to determine the quality of life of the person. For each question, they are asked to choose the most appropriate one from the Poor, Fair, Good or Excellent answers.Higher scores indicate better quality of life.
Time Frame
eight weeks
Title
Geriatric Depression Scale(GDS)
Description
The scale consists of 30 questions questioning how the participant felt in the past week. The person is asked to give the appropriate Yes(0) or No(1) answer to each question.Scores higher than 5 indicate depression.
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
Dual-Task Questionnaire(DTQ)
Description
The Dual Task Questionnaire assesses the frequency of difficulties experienced by individuals with neurological injury or disease during activities of daily living that involve dual tasks. DTQ is scored between 0-40. Higher scores indicate more frequent dual-task difficulties.
Time Frame
eight weeks
Title
Modified Falling Efficacy Scale(MFES)
Description
The scale consists of 14 items. On a scale of 0 to 10 (on the scale), the participant asked how safe they feel doing each of these activities without falling, with 0 being "not safe/not sure", 5 "quite safe/quite confident", and 10 "completely safe/ are asked to rate it in terms of being completely sure.
Time Frame
eight weeks
Title
Mini Mental Test(MMT)
Description
Scoring is made between 0-30 on the scale in which the sub-headings of orientation, recording memory, attention and calculation, recall, language are evaluated.Lesser scores indicate worse cognitive function.
Time Frame
eight weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
having been diagnosed with mild or moderate Alzheimer's disease
able to walk with or without assistance
having sufficient visual and auditory ability to perform the cognitive tests
being fit to perform physical exercises
being able to participate in proposed interventions and assessments
Exclusion Criteria:
having a neurological disorder other than Alzheimer
having any musculoskeletal problems that can affect balance
having any contraindication to exercise
functional limitation or sensory impairment that may affect performance
major depression
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet OZKESKIN, PhD
Phone
+905056631833
Email
mehmet.ozkeskin99@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zehranur BENZER, BSc
Phone
+905316265642
Email
zehrabnzr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevnaz ŞAHIN, PhD
Organizational Affiliation
Ege University
Official's Role
Study Chair
Facility Information:
Facility Name
Karsiyaka Municipality Day Living Center
City
İzmir
State/Province
Karsıyaka
ZIP/Postal Code
35580
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zehranur BENZER, BSc
Phone
+905316265642
Email
zehranrbnzr@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effects of Dual-Task Training In Individuals With Alzheimer
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