NCT05765552

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

March 1, 2023

Last Update Submit

November 18, 2025

Conditions

Keywords

AlzheimerFear of fallingDual-taskBalanceCognition

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Dual-Task Questionnaire(DTQ)

    eight weeks

  • Modified Falling Efficacy Scale(MFES)

    eight weeks

  • Mini Mental Test(MMT)

    eight weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Other: Control Group

Dual-Task Training Group

EXPERIMENTAL

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.

Other: Dual-Task Training

Interventions

Motor-cognitive dual-task exercises will be applied for 2 days a week for 8 weeks.Sessions will last for 30 minutes.

Dual-Task Training 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.

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karsiyaka Municipality Day Living Center

Izmir, Karsıyaka, 35580, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sevnaz ŞAHIN, PhD

    Ege University

    STUDY CHAIR

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
Asisstant Professor

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 13, 2023

Study Start

April 15, 2023

Primary Completion

December 15, 2023

Study Completion

April 15, 2024

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations