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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05765552
Other study ID # MOzkeskin874
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 15, 2023
Est. completion date April 15, 2024

Study information

Verified date March 2023
Source Ege University
Contact Mehmet OZKESKIN, PhD
Phone +905056631833
Email mehmet.ozkeskin99@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date April 15, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dual-Task Training
Motor-cognitive dual-task exercises will be applied for 2 days a week for 8 weeks.Sessions will last for 30 minutes.
Control Group
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.

Locations

Country Name City State
Turkey Karsiyaka Municipality Day Living Center Izmir Karsiyaka

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. eight weeks
Primary 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. eight weeks
Primary 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 eight weeks
Primary 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. eight weeks
Primary 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. eight weeks
Secondary 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. eight weeks
Secondary 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. eight weeks
Secondary 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. eight weeks
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