Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000881639
Ethics application status
Approved
Date submitted
24/11/2022
Date registered
16/08/2023
Date last updated
16/08/2023
Date data sharing statement initially provided
16/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of cognitive and motor combination training on cognition and fitness in middle-aged adults.
Scientific title
The effect of cognitive and motor combination training on cognition and fitness in middle-aged adults.
A single-blind randomized controlled trial
Secondary ID [1] 308497 0
None
Universal Trial Number (UTN)
U1111-1285-4087
Trial acronym
CCFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related cognitive decline 328305 0
Condition category
Condition code
Public Health 325353 325353 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will do moderate fitness training into which cognitive stimuli have been incorporated according to the intervention model of Thinking In Motion (TIM- tim-method.com). For example, squats, burpee, step and touch exercises and more will be performed by reading signs on the screen that will indicate the direction of movement, time of movement, waiting times at different points of the movement and other signs that create a coordinate challenge, the need to learn the signs for the specific exercise as well as a challenge related to literacy and interpretation of a symbol for movement in space.
An example of the exercise can be found in the article: https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03403-x?fbclid=IwAR3MguAXa-0rKNJ6_3FkBNqZDKg0OYNp9XOAct0FXed7HA3LmcjtV7mEP-k

Subjects will be asked to exercise a total of two hours a week for 12 weeks.
The training time will be divided into two sessions of one hour each or four sessions of 30 minutes according to the personal preference of the subjects.
The training will be designed by a certified fitness trainer with a consultation with a physical therapist and a certified TIM trainer.
Intervention will be delivered through training videos. Each subject will train independently, at home. In the videos, several versions will be offered for performing the same exercise according to different levels of difficulty so that each subject can adjust the training level to his abilities.
subjects will receive reminders on the days and hours they choose. In addition, subjects will be asked to fill out a training diary and report whether they trained, how long and how difficult it was.
In addition, the video broadcasting system allows researchers to obtain information from the habits of the viewing times of the videos.

Upon opening each video, the following message will appear:
You have been admitted to this training program based on a declaration of good health. For any change or pain that appears, please seek advice from the attending physician or the research team. The training should be challenging but comfortabole to do. The goal is to reach a certain level of breathing but not beyond such a level that it becomes difficult to conduct a short conversation.
4-6 in RPE Scale
(Rating Perceived Exertion Level
0 No exertion, at rest
1 Very light
2-3 Light
4-5 Moderate, somewhat hard
6-7 High, vigorous)
Intervention code [1] 324928 0
Treatment: Other
Intervention code [2] 324929 0
Lifestyle
Comparator / control treatment
The control group will do classic moderate fitness training For example, squats, burpee, step and touch exercises and more.
Subjects will be asked to exercise a total of two hours a week for 12 weeks.
The training time will be divided into two sessions of one hour each or four sessions of 30 minutes according to the personal preference of the subjects.
The training will be designed by a certified fitness trainer with a consultation with a physical therapist.
Intervention will be delivered through training videos. Each subject will train independently, at home. In the videos, several versions will be offered for performing the same exercise according to different levels of difficulty so that each subject can adjust the training level to his abilities.

Subjects will receive reminders on the days and hours they choose. In addition, subjects will be asked to fill out a training diary and report whether they trained, how long and how difficult it was.
In addition, the video broadcasting system allows researchers to obtain information from the habits of the viewing times of the videos.

Upon opening each video, the following message will appear:
You have been admitted to this training program based on a declaration of good health. For any change or pain that appears, please seek advice from the attending physician or the research team. The training should be challenging but comfortabole to do. The goal is to reach a certain level of breathing but not beyond such a level that it becomes difficult to conduct a short conversation.
4-6 in RPE Scale
(Rating Perceived Exertion Level
0 No exertion, at rest
1 Very light
2-3 Light
4-5 Moderate, somewhat hard
6-7 High, vigorous)
Control group
Active

Outcomes
Primary outcome [1] 333210 0
(BrainCare Tests-NeuroTrax+ Trail Making Test (TMT-B)21 ) Brain fitness:
Global score which includes the inclusion of
• Memory
• Executive function
• Attention
• Visual spatial
• Verbal function
• Problem solving
• Working memory
Timepoint [1] 333210 0
First point: two weeks before intervention
Second point: up to a week after intervention
Primary outcome [2] 333442 0
Physical capacity (PC) which includes the inclusion of muscular strength, balance, cardiorespiratory fitness, agility
Timepoint [2] 333442 0
First point: a week before intervention
Second point: up to two weeks after intervention
Primary outcome [3] 333443 0
The price of performing a dual task as part of a tandem walk
Timepoint [3] 333443 0
First point: a week before intervention
Second point: up to two weeks after intervention
Secondary outcome [1] 416178 0
Changes in physical activity habits- IPAQ
Timepoint [1] 416178 0
First point: two weeks before intervention
Second point: up to a week after intervention
Secondary outcome [2] 416179 0
Sleep quality assessment questionnaire -PSQI
Timepoint [2] 416179 0
First point: two weeks before intervention
Second point: up to a week after intervention
Secondary outcome [3] 416180 0
Objective data regarding sleep quality and physical activity habits will be collected by Actigraph GT3X wearable device
Timepoint [3] 416180 0
During a period of two weeks before the intervention and two weeks after the intervention
Secondary outcome [4] 416181 0
Physiological indicators - weight (kg) on a digital scales, hip circumference (cm) by tape measure, BMI.
Timepoint [4] 416181 0
First point: a week before intervention
Second point: up to two weeks after intervention
Secondary outcome [5] 416182 0
The short Depression, Anxiety and Stress Scale (DASS)
Timepoint [5] 416182 0
First point: two weeks before intervention
Second point: up to a week after intervention
Secondary outcome [6] 416183 0
Sleep diary - what time did you go to sleep, what time did you wake up, what causes you to wake up
Timepoint [6] 416183 0
During a period of two weeks before the intervention and two weeks after the intervention
Secondary outcome [7] 416184 0
An open questionnaire on the degree of motivation for training and reasons designed specifically for this study
Timepoint [7] 416184 0
One month after intervention
Secondary outcome [8] 416185 0
Persistence in training according to self-report in a digital diary to which a link will be sent to the subjects after each training date+ data from the recording system
Timepoint [8] 416185 0
Self-report training diary throughout the intervention period after each training date.
One open interview month after the intervention ends.

Eligibility
Key inclusion criteria
(1) Age 45-60. (2) Hebrew speakers. (3) Technical possibility to exercise in front of a screen twice a week (4) Able to understand and sign a consent form (5) Not engaged in physical activity regularly in the last six months (twice a week or more) (6) A valid health declaration, signed/doctor's approval
Minimum age
45 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Lack of free time to participate in the experiment or the evaluation sessions (2) Acute illness (3) Acute complaint related to the muscles and skeleton These include a fracture, sprain or tear of a ligament in the last year and surgery in the last six months or a complaint of recurring acute pain (4) Chronic disability of orthopedic or neurological origin, (5) any chronic condition that may limit physical and cognitive function, for example, dementia, COPD, heart disease (6) use of any medications that may affect physical performance or pose a potential risk for physical exertion

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Subjects receive one of two different interventions - and train independently. The intervention period will be at personal times for each subject according to the recruitment time.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
According to sample sizes in studies in a similar population, using the same main measurement tool

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 25156 0
Israel
State/province [1] 25156 0
The center of the country - around Tel Aviv and the Sharon area

Funding & Sponsors
Funding source category [1] 312739 0
University
Name [1] 312739 0
University of Haifa
Country [1] 312739 0
Israel
Primary sponsor type
University
Name
University of Haifa
Address
University of Haifa, 199 Abba Khushi Ave., Haifa 3498838
Country
Israel
Secondary sponsor category [1] 314359 0
None
Name [1] 314359 0
Address [1] 314359 0
Country [1] 314359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312034 0
Faculty Research Ethics Committee The Faculty of Welfare and Health Sciences, University of Haifa
Ethics committee address [1] 312034 0
Ethics committee country [1] 312034 0
Israel
Date submitted for ethics approval [1] 312034 0
04/12/2022
Approval date [1] 312034 0
05/01/2023
Ethics approval number [1] 312034 0
014/23

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123254 0
Prof Maayan Agmon
Address 123254 0
University of Haifa, 199 Abba Khushi Ave., Haifa 3498838
Country 123254 0
Israel
Phone 123254 0
+972549001609
Fax 123254 0
Email 123254 0
[email protected]
Contact person for public queries
Name 123255 0
Shiri Embon Magal
Address 123255 0
University of Haifa, 199 Abba Khushi Ave., Haifa 3498838
Country 123255 0
Israel
Phone 123255 0
+972547692487
Fax 123255 0
Email 123255 0
[email protected]
Contact person for scientific queries
Name 123256 0
Mayyan Agmon
Address 123256 0
University of Haifa, 199 Abba Khushi Ave., Haifa 3498838
Country 123256 0
Israel
Phone 123256 0
+972549001609
Fax 123256 0
Email 123256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.