Trial Review

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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 information initially 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).
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.
Secondary ID [1] 290185 0
None
Universal Trial Number (UTN)
Trial acronym
TIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
1. Motor functions – Walking quality

 300325 0
2. Motor functions – Dual Task 300327 0
Condition category
Condition code
Neurological 300194 300194 0 0
Studies of the normal brain and nervous system
Physical Medicine / Rehabilitation 300629 300629 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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 .
Intervention code [1] 295941 0
Treatment: Other
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 .
Control group
Active

Outcomes
Primary outcome [1] 299677 0
Change in the quality performance of dual task.
Using:Dual task test
Timepoint [1] 299677 0
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.
Primary outcome [2] 299678 0
Change in the quality performance of walking (step frequency Duration, Step time).
Using: Macroberts lab walk
Timepoint [2] 299678 0
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.
Primary outcome [3] 299679 0
Change in cognitive performance.
Using:MoCA test+ Cognifit cognitive assessment.
Timepoint [3] 299679 0
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.
Secondary outcome [1] 327817 0
Questionnaire for assessing depression – GDS
Timepoint [1] 327817 0
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.
Secondary outcome [2] 327818 0
A questionnaire to assess anxiety- SAST
Timepoint [2] 327818 0
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.
Secondary outcome [3] 327819 0
questionnaire for assessing the fear of falling- ABC
Timepoint [3] 327819 0
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.
Secondary outcome [4] 327820 0
Questionnaire evaluating sleep quality - ( PSQI )
Timepoint [4] 327820 0
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.

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
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
( 1 ) Sitting in wheelchairs . ( 2 ) People who were unavailable to fully participate in the interventions and trials

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/06/2016
Date of last participant enrolment
Anticipated
Actual
1/08/2016
Date of last data collection
Anticipated
Actual
22/08/2016
Sample size
Target
62
Accrual to date
Final
62
Recruitment outside Australia
Country [1] 8248 0
Israel
State/province [1] 8248 0

Funding & Sponsors
Funding source category [1] 294546 0
Charities/Societies/Foundations
Name [1] 294546 0
EMDA Association
Country [1] 294546 0
Israel
Primary sponsor type
University
Name
University of Haifa
Address
University of Haifa
Department of Gerontology
Aba hushi 199
Har hacarmel- heifa.
Israel.
Country
Israel
Secondary sponsor category [1] 293417 0
None
Name [1] 293417 0
Address [1] 293417 0
Country [1] 293417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295985 0
The faculty ethics committee for Study of human - University of Haifa
Ethics committee address [1] 295985 0
31905 Mount Carmel, Haifa, Israel 31905
Ethics committee country [1] 295985 0
Israel
Date submitted for ethics approval [1] 295985 0
26/03/2016
Approval date [1] 295985 0
10/04/2016
Ethics approval number [1] 295985 0
N'(137/16)

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
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1125 1125 0 0
/AnzctrAttachments/371522-????? ???? 1352 - ????' ???? ????? ?? ????? ????? ????? ????? ??? 137-16 (1).pdf (Ethics approval)
Attachments [2] 1126 1126 0 0
/AnzctrAttachments/371522-????? GCP ???? ????? ???.pdf (Other)

Contacts
Principal investigator
Name 69146 0
Ms Maayan Agmon
Address 69146 0
University of Haifa.
31905 Mount Carmel, Haifa,
Country 69146 0
Israel
Phone 69146 0
+972547692487
Fax 69146 0
Email 69146 0
[email protected]
Contact person for public queries
Name 69147 0
Ms Maayan Agmon
Address 69147 0
University of Haifa.
31905 Mount Carmel, Haifa,
Country 69147 0
Israel
Phone 69147 0
+972547692487
Fax 69147 0
Email 69147 0
[email protected]
Contact person for scientific queries
Name 69148 0
Dr Mayayn Agmon
Address 69148 0
University of Haifa.
31905 Mount Carmel, Haifa,
31905
Country 69148 0
Israel
Phone 69148 0
+972549001609
Fax 69148 0
Email 69148 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Evaluation tool results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication;
Available to whom?
anyone who wishes to access it,
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16234Study protocol  [email protected] N/A
16235Statistical analysis plan  [email protected] Similar to other supporting documents
16236Clinical study report  [email protected] Similar to other supporting documents
16237Ethical approval  [email protected]
16238Informed consent form  [email protected] Similar to other supporting documents
16239Analytic code  [email protected] Similar to other supporting documents



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 371522-(Uploaded-26-05-2022-21-03-32)-Basic results summary.docx
Plain language summaryNo Cognition and motor skills are interrelated throu... [More Details]

Documents added automatically
No additional documents have been identified.