Trial document




This trial has been registered retrospectively.
drksid header

  DRKS00022407

Trial Description

start of 1:1-Block title

Title

Training-induced plasticity of multitasking in everyday-like motor behavior

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

MIND2

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

https://www.uni-muenster.de/Sportwissenschaft/Neuromotor-Behavior/forschung/mind/index.html

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In everyday life we are often confronted with situations in which we have to carry out several tasks at the same time, so-called multitasking (e.g. driving a car while talking to a passenger, walking through the city while writing a message on the smartphone, etc.). With increasing age, multitasking becomes more difficult; the consequences are reduced performance, failure, and increasing risks of accidents and injuries. In long-term this can even lead to the loss of an independent and autonomous life. Scientific studies suggest that age-related changes in cognitive and motor functions and the associated restrictions in everyday life can be counteracted by targeted and tailored training. The aim of this project is to find out how exactly such a training intervention has to be designed in order to successfully improve multitasking skills. Study participants between 65 and 75 years of age are monitored for several months. They take part in different training interventions that train both mental and physical fitness. The success of the training is assessed by motor, neurophysiological and cognitive tests before and after the training phase.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The objective of the project is to investigate the benefits of individualized, adaptive training ("tailored training") to improve cognitive-motor multitasking. In a randomized, single-blind, three-armed, twelve-week intervention-study, subjects will be assigned to one of three experimental groups: (1) motor training, (2) cognitive training (3) cognitive-motor multitasking-training. Different motor, cognitive, physiological and neuronal measures are assessed in pre- and post-tests. The study aims to find out whether (1) subjects with motor deficits benefit more from a purely motor training than from multitasking-training, (2) subjects with cognitive deficits benefit more from a purely cognitive training than from multitasking-training, and (3) subjects without motor and cognitive deficits benefit more from multitasking training than from a purely motor or purely cognitive training.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

Anonymized individual participant data is made available to the public within open access publications. A peer-reviews and published study protocol contains a description of the methods and the statistical analysis plan.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00022407
  •   2020/08/26
  •   [---]*
  •   yes
  •   Approved
  •   V-280-17-CVR-Multitasking-29062018, Ethikkommission der Fakultät Human- und Sozialwissenschaften der Technischen Universität Chemnitz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   healthy elderly people, aged between 65 and 75 years
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Twelve-week cognitive training. The contents are composed of different cognitive tasks. The sessions take place in groups twice a week for 45-60 minutes. Before and after the intervention, cognitive and motor performance as well as other personal and psychological variables are assessed.
  •   Twelve-week motor training. The contents consist of various balance, flexibility and strengthening exercises. Except for the contents of the training, all variables are kept the same as in Arm 1.
  •   Twelve-week cognitive-motor multitasking-training. The contents consist of the same exercises as in cognitive and motor training and are executed in combination (i.e. a simultaneous execution of cognitive and motor tasks). Except for the contents of the training, all variables are kept the same as in Arm 1 and Arm 2.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   I-II
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary endpoint is the identification of the influence of training effects on the behavioral (cognitive and motor) and neural level in regard to the initial cognitive and motor performance in (virtual) scenarios containing multiple tasks. All examinations are carried out in longitudinal section at two measurement points at a time interval of twelve weeks (before and after the intervention).

Measurement instruments:
- Tracking task (in combination with a motor-auditiv task)
- Virtual driving task (realistic multitasking task)
- Virtual walking task (realistic multitasking task, in combination with the Stroop test and the Digit Symbol Substitution test)
- fNIRS

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

The secondary endpoint is the assessment of general physical and cognitive fitness. All examinations are carried out in longitudinal section at two measurement points at a time lag of twelve weeks (before and after the intervention).

Measurement instruments:
- Questionnaire to determine subjective and objective health, and social participation
- Campimetry test
- German adaptation of the Baecke Physical Activity questionnaire
- German adaptation of the Falls Efficacy Scale
- Questionnaire on the number, location and causes of falls
- Mini Mental Status Examination
- Keep-track test
- Spatial 2-back test
- Simon test
- Switching test
- Tapping test
- Pegboard test
- Posture test
- Chairstand test

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/03/04
  •   150
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- right handed
- car driving practice (e.g., at least once a week within the last 6 months)
- ability to walk without walking aids / ability to walk for 30 minutes without negative physical conditions (e.g., - - - difficulty to breath, pain, and cardiac palpations)
- medical clearance certificate (e.g., negative exercise ECG and clinically unremarkable medical history)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- BMI > 30
- non-corrected low vision
- red-green deficiency or red-green-colour blindness
- orthopedic handicaps
- perceived health problems
- neurological diseases
- cardiovascular disorders
- previous heart attack or stroke
- previous surgery at the head/brain.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • WWU Münster, Institut für Sportwissenschaft, Arbeitsbereich Neuromotorik und Training
    • Ms.  Prof.  Claudia  Voelcker-Rehage 
    • Horstmarer Landweg 62b
    • 48149  Münster
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • WWU Münster, Institut für Sportwissenschaft, Arbeitsbereich Neuromotorik und Training
    • Ms.  Prof.  Claudia  Voelcker-Rehage 
    • Horstmarer Landweg 62b
    • 48149  Münster
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address scientific-contact
    • WWU Münster, Institut für Sportwissenschaft, Arbeitsbereich Neuromotorik und Training
    • Mr.  M.Sc.  Robert  Stojan 
    • Horstmarer Landweg 62 b
    • 48149  Münster
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address scientific-contact
    • Deutsche Sporthochschule Köln, Institut für Trainingswissenschaft und Sportinformatik
    • Mr.  Prof. Dr.  Otmar  Bock 
    • Am Sportpark Müngersdorf 6
    • 50927  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • WWU Münster, Instiut für Sportwissenschaft, Arbeitsbereich Neuromotorik und Training
    • Ms.  M.Sc.  Melanie  Mack 
    • Horstmarer Landweg 62 b
    • 48149  Münster
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting suspended on temporary hold
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.