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Trial registered on ANZCTR
Registration number
ACTRN12616001543471
Ethics application status
Approved
Date submitted
20/09/2016
Date registered
8/11/2016
Date last updated
30/05/2022
Date data sharing statement initially provided
30/05/2022
Date results provided
30/05/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of cognitive and motor functions in older adults, after participating in "Thinking in Motion" intervention, based on Eshkol-Wachmann Movement Notation (EWMN).
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Scientific title
Evaluation of cognitive and motor functions in older adults, after participating in "Thinking in Motion" intervention, based on EWMN: A randomized clinical trial.
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Secondary ID [1]
290185
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None
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Universal Trial Number (UTN)
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Trial acronym
TIM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
1. Motor functions – Walking quality
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2. Motor functions – Dual Task
300327
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Condition category
Condition code
Neurological
300194
300194
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0
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Studies of the normal brain and nervous system
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Physical Medicine / Rehabilitation
300629
300629
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Thinking in motion-
A physical training program , which offers cognitive challenge's as dual task, memory Challenge's, attention Challenge's, orientation Challenge's
and more: based on EWMN motion Observation.
Training takes place 3 times a week for 3 months in groups of max 14 participants for 45 minutes.
The intervention sessions are designed in three parts:
A. Warm-up- preparing the body for physical activity, experience working with rhythm, mood elevation and motivation. The warm-up takes place in a circle with rhythmic background music. This part has both physically and mentally purpose. Exercises intervention may be frustrating for practitioners and one of the goals in the warm-up is to create a good atmosphere high spirits motivation, fun and create a sense of partnership. The warm-up structure is inspired by dance therapy groups of Chase (Chaiklin, Schmais, & Lewis, 1986). Additionally, the warm-up is important for softening the joints, increasing range of motion, strengthening muscle power, balance and other contractile elements relevant to exercises which will appear later in the practice.
B. The central part of the training - The exercise session will focus on one or two exercises how will develop. The exercises is performed with metronome background or music.
C. End - creating a ending activity, coping positively with frustration and a sense of partnership. Closer will take place by highlighting success and carrying out a task as a meaningful achievement and as a "grand Finale " . In addition, the physical goal is to bring the body into a state of rest, stretching muscles, and regulation of breathing.
The intervention is face to face with a guide in a closed room, with a circle of chairs, music and blackboard.
The intervention is customized by level of functioning of the group members.
The intervention guide hes a BE.d degree and a teaching certificate in the field of theater and dance and MA in movement therapy from the University of Haifa . Has extensive experience in dance training and experience of three years working with the elderly in movement .
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Intervention code [1]
295941
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Treatment: Other
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Comparator / control treatment
The control group is given the option to train independently using a computer training course by Cognifit/ they are given the recommendation to practice 3 times a week for 3 months
During working hours at the center day they heve the possibility to request technical support for connecting the software and reading the tasks.
The software provides computer training. Each training session lasts 20 minutes+- . The training includes 3-4 a short games practicing different cognitive abilities .
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in the quality performance of dual task.
Using:Dual task test
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Assessment method [1]
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Timepoint [1]
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All tests will be held before the start of the intervention and immediately when the intervention ends or not later than one 2 weeks the end.
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Primary outcome [2]
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Change in the quality performance of walking (step frequency Duration, Step time).
Using: Macroberts lab walk
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Assessment method [2]
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Timepoint [2]
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All tests will be held before the start of the intervention and immediately when the intervention ends or not later than one 2 weeks the end.
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Primary outcome [3]
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Change in cognitive performance.
Using:MoCA test+ Cognifit cognitive assessment.
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Assessment method [3]
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Timepoint [3]
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All tests will be held before the start of the intervention and immediately when the intervention ends or not later than one 2 weeks the end.
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Secondary outcome [1]
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Questionnaire for assessing depression – GDS
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Assessment method [1]
327817
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Timepoint [1]
327817
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All tests will be held before the start of the intervention and immediately when the intervention ends or not later than one 2 weeks the end.
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Secondary outcome [2]
327818
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A questionnaire to assess anxiety- SAST
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Assessment method [2]
327818
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Timepoint [2]
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All tests will be held before the start of the intervention and immediately when the intervention ends or not later than one 2 weeks the end.
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Secondary outcome [3]
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questionnaire for assessing the fear of falling- ABC
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Assessment method [3]
327819
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Timepoint [3]
327819
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All tests will be held before the start of the intervention and immediately when the intervention ends or not later than one 2 weeks the end.
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Secondary outcome [4]
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Questionnaire evaluating sleep quality - ( PSQI )
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Assessment method [4]
327820
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Timepoint [4]
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All tests will be held before the start of the intervention and immediately when the intervention ends or not later than one 2 weeks the end.
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Eligibility
Key inclusion criteria
( 1 ) Age : 60 or older ( 2 ) have the ability to walk independently or with the help of a accessory for walking
. ( 3 ) Suitable for self-signing the consent to participate . ( 4 ) Hebrew speaker
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
( 1 ) Sitting in wheelchairs . ( 2 ) People who were unavailable to fully participate in the interventions and trials
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At first the subjects were tested in order to examine the
Criteria of the trail and cognitive status , then divided randomly by an independent tester.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin-tossing
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
T-test
Manova repeated measures
G POWER BASED on 0.05 effect size was conducted to select the sample size. To prevent attrition we over sample and arrived at 62 (31 in each group
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
30/06/2016
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Date of last participant enrolment
Anticipated
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Actual
1/08/2016
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Date of last data collection
Anticipated
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Actual
22/08/2016
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Sample size
Target
62
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Accrual to date
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Final
62
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Recruitment outside Australia
Country [1]
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Israel
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State/province [1]
8248
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Funding & Sponsors
Funding source category [1]
294546
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Charities/Societies/Foundations
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Name [1]
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EMDA Association
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Address [1]
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Ranat-Gan 8261
mailbox- 5218
Israel
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Country [1]
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Israel
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Primary sponsor type
University
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Name
University of Haifa
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Address
University of Haifa
Department of Gerontology
Aba hushi 199
Har hacarmel- heifa.
Israel.
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Country
Israel
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
293417
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Country [1]
293417
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295985
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The faculty ethics committee for Study of human - University of Haifa
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Ethics committee address [1]
295985
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31905 Mount Carmel, Haifa, Israel 31905
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Ethics committee country [1]
295985
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Israel
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Date submitted for ethics approval [1]
295985
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26/03/2016
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Approval date [1]
295985
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10/04/2016
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Ethics approval number [1]
295985
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N'(137/16)
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Summary
Brief summary
This study examines the effectiveness of a unique movement intervention which is based on a theoretical model and inspiration by Eshkol Wachman motion note (EWMN). This study examines the effect of this intervention on walking ability in ecological situations, by performing a dual-task (walking while performing a cognitive task simultaneously). While examining the inclusion potential in this training and examining other parameters that has potential to underlie expected changes as cognitive function, depression, anxiety, and sleep quality. The study is a randomized clinical trial. At the beginning of the study T0- tests will be executed. After examining the results of the MoCA test, subjects will be divided according to cognitive function to control it as a intervening variable. After this distribution, the subjects will randomly be divided into intervention and control group. The intervention group will receive training three times a week for three months and the control group will be given the opportunity to train independently using a computer training program by Cognifit- with a recommendation to practice three times a week for 3 months. After three months of training subject will be test again- T1, to examine the effect of the exercise. The main hypothesis of the research is that the intervention group will improve in dual-task performance and improve in the quality of walking such as speed, step size and variability of steps. Such findings will indicate this training to be effective in improving the quality of walking and hopefully helps to reduce falls in the elderly
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
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/AnzctrAttachments/371522-????? ???? 1352 - ????' ???? ????? ?? ????? ????? ????? ????? ??? 137-16 (1).pdf
(Ethics approval)
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Attachments [2]
1126
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/AnzctrAttachments/371522-????? GCP ???? ????? ???.pdf
(Other)
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Contacts
Principal investigator
Name
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Ms Maayan Agmon
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Address
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University of Haifa.
31905 Mount Carmel, Haifa,
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Country
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Israel
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Phone
69146
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+972547692487
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Fax
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Email
69146
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[email protected]
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Contact person for public queries
Name
69147
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Maayan Agmon
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Address
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University of Haifa.
31905 Mount Carmel, Haifa,
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Country
69147
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Israel
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Phone
69147
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+972547692487
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Fax
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Email
69147
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[email protected]
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Contact person for scientific queries
Name
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Mayayn Agmon
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Address
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University of Haifa.
31905 Mount Carmel, Haifa,
31905
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Country
69148
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Israel
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Phone
69148
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+972549001609
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Fax
69148
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Email
69148
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Evaluation tool results
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication;
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Available to whom?
anyone who wishes to access it,
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Available for what types of analyses?
any purpose
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How or where can data be obtained?
access subject to approvals by Principal Investigator
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
16234
Study protocol
[email protected]
N/A
16235
Statistical analysis plan
[email protected]
Similar to other supporting documents
16236
Clinical study report
[email protected]
Similar to other supporting documents
16237
Ethical approval
[email protected]
16238
Informed consent form
[email protected]
Similar to other supporting documents
16239
Analytic code
[email protected]
Similar to other supporting documents
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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