Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00020518

Trial Description

start of 1:1-Block title

Title

KerVita - prevention in nursing homes

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

Trial Acronym

KerVita

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

[---]*

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

Brief Summary in Scientific Language

Multimodal exercise programmes are recommended to counteract age-related functional and mobility losses and to promote mobility (Crocker et al., 2013). The prevention programme of the PROCARE study has proven to be effective in this respect. The small life space of nursing home residents, which is often limited to their own space (Jansen et al., 2017), could also be related to the age-related reduction in spatial orientation (deIpolyi et al., 2007). The present study investigates whether additional promotion of spatial orientation ability can counteract mobility impairments. The improvement of orientation ability through cognitive training with orientation tasks is confirmed by Mitolo et al. (2017). It is unclear whether a combination of movement and orientation tasks can counteract the degeneration, extend the life space and thus promote the mobility of residents more efficiently. As an extension of the PROCARE study, orientation tasks and change of location are to be incorporated into the existing prevention programme and implemented in a randomised controlled trial in a parallel group design in four KerVita care facilities. In consultation with the nursing staff and on the basis of the nursing documentation, a total of at least 103 residents will be recruited and randomly assigned to an intervention group (PROCARE with orientation tasks) and a control group (PROCARE).

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:

The anonymised data and the study protocol can be obtained from the study director.

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

Organizational Data

  •   DRKS00020518
  •   2020/02/19
  •   [---]*
  •   yes
  •   Approved
  •   2019_248, Lokale Ethikkommission Fakultät Psychologie und Bewegungswissenschaft Universität Hamburg
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

  •   M00-M99 -  Diseases of the musculoskeletal system and connective tissue
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   multicomponent exercise intervention (12 weeks/twice a week/45-60 minutes)
  •   multicomponent exercise intervention with change of location (12 weeks/twice a week/45-60 minutes)
  •   multicomponent execise intervention with change of location and orientation tasks (12 weeks/twice a week/45-60 minutes)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   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

Retention rate:
Number of people who have completed the intervention
Number of Drop Outs (reasons for this)
Adverse events/ incidents
Attendance rate

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

Secondary Outcome

Input and output measurements (after 12 weeks)

Satisfaction with Life: Satisfaction with Life Scale (Questionnaire)

Health status: Short Form-12 (Questionnaire)

Depression: Geriatric Depression Scale 12 Residential (Questionnaire)

Orientation and orientation strategies:
self-report measure of environmental spatial strategies (Questionnaire)
Spatial Anxiety Scale (Questionnaire)
prospective taking (Questionnaire)
Route Reproduction Task (Assessment)
pointing task (Assessment)

Mobility (Assessments): Timed-Up-and-Go test, Short Physical Performance Battery

Physical activity: ActivPal accelerometer

Hand grip strength: Hand grip strength dynamometer

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

Recruitment

  •   Actual
  •   2019/09/04
  •   103
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Voluntary participation
Resident of the nursing home
ability to sit independently and upright
ability to follow the instructions of the trainers
ability to paticipate in a group

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

Exclusion Criteria

contraindication of participation expressed by the doctor and nursing staff

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Hamburg Institut für Bewegungswissenschaft Arbeitsbereich Bewegungs- und Trainingswissenschaft
    • Mollerstraße 10
    • 20148  Hamburg
    • 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
    • Universität Hamburg Institut für Bewegungswissenschaft Arbeitsbereich Bewegungs- und Trainingswissenschaft
    • Ms.  Adele  Kruse 
    • Mollerstraße 10
    • 20148  Hamburg
    • 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
    • Universität Hamburg Institut für Bewegungswissenschaft Arbeitsbereich Bewegungs- und Trainingswissenschaft
    • Ms.  Adele  Kruse 
    • Mollerstraße 10
    • 20148  Hamburg
    • 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
    • Techniker Krankenkasse
    • Bramfelder Straße 140
    • 22305  Hamburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • KerVita Betriebs GmbH
    • Kuehnstraße 71
    • 22045  Hamburg
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
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.