Trial document




drksid header

  DRKS00015249

Trial Description

start of 1:1-Block title

Title

"PROCARE-prevention in stationary care facilities"- prevention program for caregivers

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

Trial Acronym

[---]*

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

Nurses working in the field of elderly care are known to be especially burdened by different situations in their daily work, e.g. lifting and carrying of the elderly and the handling of mentally confused and aggressive patients. Research has shown that those working situations lead to higher stress levels and diseases of the back muscles and bones. Other scientific studies found that physical activity programs are able to reduce these back problems.
The aim of the randomized controlled study is to investigate the influence of a physical activity program on the movement behavior and the strength endurance of the back-extensor muscles of nursing staff. The intervention program focuses on posture training separately and in combination with a back-fitness routine. It comprises two movement programs which take place at different times.

1. ergonomics and posture training (Wollesen, Lex & Mattes 2012)
2. back-fitness.

The first program is a 10-week physical activity program which focuses on posture training and takes place once a week for a period of 20 to 30 minutes. It includes the learning of different techniques, in order to deal with physically challenging situations at the work place. The back-fitness program includes the components mobility, coordination, strength and relaxation. Strength training is divided into 3 phases, each lasting 4 weeks. An increase in load is planned in each phase.
To obtain a verifiable structure, the program was divided as follows:

1. mobility training (5-10 minutes)
2. coordination training (10-15 minutes)
3. strength training (30-40 minutes)
4. relaxation (5-10 minutes)

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

Brief Summary in Scientific Language

The demographic change causes increasing numbers of elderly, who are increasingly bedridden (Statistisches Bundesamt 2017). Moreover, an average number of 27.5 days of inability to work per employee were documented in 2015 in the healthcare sector (Badura et al. 2016). Burdens resulting from heavy lifting and carrying are among the reasons for the inability to work (Jenull-Schiefer et al. 2007) as well as psycho-sociological factors that emerge from e.g., handling mentally disturbed and aggressive patients (Demir et al. 2003), the death of patients and limited rehabilitation results (Jenull-Schiefer et al. 2007). Backpain occurs in 80-85% of all geriatric nurses and it is often correlated to a high psycho-social workload (Karahan et al. 2009). Research has shown that frequently performed transferring tasks when pressed for time and in unfavorable postures (e.g., turning and holding patients) cause lumbar tissue damage and backpain (Seidler et al. 2011; Eriksen 2004). Further studies indicate that regular muscle building training in combination with cardiorespiratory training leads to a reduction of musculoskeletal complaints (Alexandre et al. 2001; Al-Eisa & Al-Abbad 2013; Kolu et al. 2017). Furthermore, the efficacy of combinational exercise programs (training in ergonomics combined with strength and flexibility training) to reduce back trouble has been proven (Gauthier et al. 2015).
The aim of the randomized controlled study is to investigate the influence of a physical activity program on the movement behavior and the strength endurance of the back-extensor muscles of nursing staff. The intervention program focuses on posture training separately and in combination with a back-fitness routine. It comprises two movement programs which take place at different times.

1. ergonomics and posture training (Wollesen, Lex & Mattes 2012)
2. back-fitness.

The first program is a 10-week physical activity program which focuses on posture training and takes place once a week for a period of 20 to 30 minutes. It includes the learning of different techniques, in order to deal with physically challenging situations at the work place. The back-fitness program includes the components mobility, coordination, strength and relaxation. Strength training is divided into 3 phases, each lasting 4 weeks. An increase in load is planned in each phase.
To obtain a verifiable structure, the program was divided as follows:

1. mobility training (5-10 minutes)
2. coordination training (10-15 minutes)
3. strength training (30-40 minutes)
4. relaxation (5-10 minutes)

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

Organizational Data

  •   DRKS00015249
  •   2018/09/05
  •   [---]*
  •   yes
  •   Approved
  •   2018_168, Lokale Ethikkommission der Fakultät Psychologie und Bewegungswissenschaft der 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

  •   ergonomics and posture training, 10 weeks, 20-30 minutes per week
  •   ergonomics and posture training, 10 weeks, 20-30 minutes per week; back-fitness, 12 weeks, 45-60 minutes per week
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)
  •   Prevention
  •   Crossover
  •   II
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary outcomes include the following parameters: Parameter: Lifting capacity, method of measurement: PILE Test, timepoints: Pretest, posttest after 10 weeks, posttest after 22 weeks and follow-up measurement after 34 weeks. Parameter: Predisposition of the upper body, method of measurement: Xsens, timepoints: Pretest, posttest after 10 weeks, posttest after 22 weeks and follow-up measurement after 34 weeks. Parameter: Strength endurance of lumbar extensors, method of measurement: Biering-Sorensen Test, timepoints: Pretest, posttest after 10 weeks, posttest after 22 weeks and follow-up measurement after 34 weeks.

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

Secondary Outcome

The secondary outcomes include the following parameters: Parameter:Total score of movement observation (wheelchair transfer), method of measurement: Movement observation sheet, timepoints: Pretest, posttest after 10 weeks, posttest after 22 weeks and follow-up measurement after 34 weeks. Parameter: Functional impairment due to back pain, questionnaire: Oswestry Disability Index, timepoints: Pretest, posttest after 10 weeks, posttest after 22 weeks and follow-up measurement after 34 weeks. Parameter: Pain intensity of back complaints, scale: VAS, timepoints: Pretest, posttest after 10 weeks, posttest after 22 weeks and follow-up measurement after 34 weeks.

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
  •   2018/09/12
  •   36
  •   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

The study includes employees who are active in the care of residents and who have no acute and/or chronic diseases of the back.

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

Exclusion Criteria

Excluded are professional housekeepers, psycho-social carers and administrative 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, Arbeitsbereich Gesundheitswissenschaft
    • 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
    • Ms.  Ann-Kathrin  Otto 
    • 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
    • Ms.  Ann-Kathrin  Otto 
    • 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
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.