Trial document




drksid header

  DRKS00012917

Trial Description

start of 1:1-Block title

Title

Minimum dose of intervention duration with effect on trunk stability and compensation of perturbations conducted within the MiSpEx-Network [National Research Network for Medicine in Spine Exercise]: National research network for diagnosis, prevention and treatment of back pain for elite athletes and the general population

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

Trial Acronym

MiSpEx - Intervention Study

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

URL of the Trial

http://mispex.de

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

Brief Summary in Lay Language

Core-specific sensorimotor exercises are proven to enhance neuromuscular activity of the trunk, improve athletic performance and prevent back pain. However, the dose-response relationship and therefore the minimum dose required to improve trunk function is still under debate. The present trial aims to identify the minimum dose of sensorimotor exercises that will result in improved trunk function. Healthy, well-trained female and male participants aged 18 to 50 years are recruited for the study.

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

Brief Summary in Scientific Language

Core-specific sensorimotor exercises are proven to enhance neuromuscular activity of the trunk, improve athletic performance and prevent back pain. However, the dose-response relationship and therefore the minimum dose required to improve trunk function is still under debate. The present trial aims to identify the minimum dose of sensorimotor exercises that will result in improved trunk function.
A single-blind, four-armed, randomized controlled trial with a 3-week (home-based) intervention phase and two measurement days pre- and post-intervention (M1/M2) is conducted.
The primary outcome is trunk strength (peak torque). Neuromuscular activity (amplitude, latencies as a response to perturbation) serves as a secondary outcome.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012917
  •   2017/08/22
  •   [---]*
  •   yes
  •   Approved
  •   23/2017, Ethikkommission der Universität Potsdam
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

  •   M54 -  Dorsalgia
  •   healthy participants
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Control Group: core-specific sensorimotor training with additional perturbation with 6 sessions in 3 weeks (4 exercises, 3 sets á 10 repetitions; home-based)
  •   Intervention group I: core-specific sensorimotor training with additional perturbation with 6 sessions in 3 weeks (3 exercises, 2 sets á 10 repetitions; home-based)
  •   Intervention group II: core-specific sensorimotor training with additional perturbation with 6 sessions in 3 weeks (2 exercises, 2 sets á 10 repetitions; home-based)
  •   Intervention group III: core-specific sensorimotor training with additional perturbation with 6 sessions in 3 weeks (1 exercise, 3 sets á 10 repetitions; home-based)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

trunk strength: isokinetic maximum strength capacity [Nm] with and without additional perturbation is assessed pre and post intervention period (M1/M2) by use of dynamometers.

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

Secondary Outcome

neuromuscular adaptation for perturbations: assessment by the muscular activity (EMG: time/amplitude measures). Before and after 3 weeks intervention.

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

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2017/09/01
  •   80
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

both gender; aged 18 - 50 years

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

Exclusion Criteria

Acute infection, pregnancy, any illness that contraindicates exercise, as well as acute or chronic back pain

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Hochschulambulanz der Universität Potsdam
    • Am Neuen Palais 10 Haus 12
    • 14469  Potsdam
    • 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
    • Hochschulambulanz der Universität Potsdam
    • Ms.  Josefine  Stoll 
    • Am Neuen Palais 10 Haus 12
    • 14469  Potsdam
    • 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
    • Hochschulambulanz der Universität Potsdam
    • Ms.  Josefine  Stoll 
    • Am Neuen Palais 10, Haus 12
    • 14469  Potsdam
    • 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
    • Bundesinstitut für Sportwissenschaft (BISp)
    • Graurheindorfer Straße 198 (Haus 7)
    • 53117  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 planned
  •   [---]*
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.