- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05817396
Dissemination of Physical Activity-related Health Competence in Vocational Education of Nursing Care (TakeCare!)
April 28, 2026 updated by: Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
Take Care! - Dissemination Von Bewegungsbezogener Gesundheitskompetenz in Der Pflegeausbildung
The "TakeCare!" study addresses the problem that vocational students of nursing care cope with great physical and psychological demands during their daily routines.
To meet these demands, the Bavarian curriculum for generalist nurses has adopted the promotion of physical activity-related health competence (PAHCO) for vocational students.
However, it must be assumed that the concept has not yet been adopted comprehensively across the Bavarian nursing landscape.
Therefore, the "TakeCare!"
study tackles the question of how PAHCO can be implemented most appropriately in Bavarian nursing schools.
Drawing on experiences from the project PArC-AVE, three different dissemination approaches will being tested and compared with a control group.
A total of 16 nursing schools from different regions of Bavaria will be assigned to four different study arms (cluster-randomized design).
In the long term, the project aims to derive recommendations for all nursing schools in Bavaria.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
335
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
Erlangen, Bavaria, Germany, 91058
- Friedrich-Alexander University Erlangen-Nürnberg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria (School/Cluster Level):
- Private or Local Sponsorship
- Location in Bavaria
- Schools with 33-64 students in the first cohort (i.e., two or three classes per cohort)
- School director providing informed written consent by March 1st 2023
Inclusion Criteria (Student Level):
- Informed written consent to participate (or their legal guardians, if aged under 18 years)
- Part of the first education year (in cohort 2023/2024)
Exclusion Criteria:
-if any of the criteria mentioned above is not given
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cooperative Planning for Promoting PAHCO
Participatively developed intervention concept by means of cooperative planning (Rütten, 1997) to promote physical activity-related health competence (PAHCO): A separate cooperative planning process will take place in each of the four schools in this study arm from April to November 2023.
Within the framework of these processes, suitable interventions tailored to the target group and the school will be developed for the implementation of the curriculum content "PAHCO" with the participation of actors from science and practice (e.g., teachers, nursing students of the schools).
The developed interventions will be implemented from December 2023 under the responsibility of the actors in the schools.
|
Intervention for the curriculum content "PAHCO" at nursing schools in Bavaria
|
|
Experimental: Expert-Based Intervention for Promoting PAHCO Delivered by External Physical Activity Specialists
Expert-based intervention concept with external physical activity specialists to promote physical activity-related health competence (PAHCO).
We will develop a specific intervention concept for the implementation of the curriculum content "PAHCO" at nursing schools in Bavaria from April to November 2023.
Currently (March 2022), it is planned that the intervention will comprise 12 sessions with a duration of 45 or 90 minutes.
The entire intervention will be specified during the different steps of intervention mapping (i.e., needs assessment, goal formulation, screening evidence-based intervention content).
Physical activity specialists (e.g.
sports scientists, physiotherapists) will be trained to implement this expert-based intervention concept from December 2023 to March 2024.
|
Intervention for the curriculum content "PAHCO" at nursing schools in Bavaria
|
|
Experimental: Expert-Based Intervention for Promoting PAHCO Delivered by Teachers
Expert-based intervention concept with teachers as multipliers to promote physical activity-related health competence (PAHCO).
We will develop a specific intervention concept for the implementation of the curriculum content "PAHCO" at nursing schools in Bavaria from April to November 2023.
Currently (March 2022), it is planned that the intervention will comprise 12 sessions with a duration of 45 or 90 minutes.
The entire intervention will be specified during the different steps of intervention mapping (i.e., needs assessment, goal formulation, screening evidence-based intervention content).
Teachers of the participating nursing schools of this study arm will be trained to implement this expert-based intervention concept in their school from December 2023 to March 2024.
|
Intervention for the curriculum content "PAHCO" at nursing schools in Bavaria
|
|
No Intervention: Regular Education and Health Promotion
No systematic intervention concept: In the schools of this study arm, there is no systematic and scientifically supported intervention for the implementation of the curriculum content "PAHCO".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity-related Health Competence (Short Term)
Time Frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
Physical Activity-related Health Competence (PAHCO) Questionnaire (Carl et al., 2020); higher percentage scores (0 min, 100 max) indicate a better outcome
|
Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
|
Psychological Movement Quality (Short Term)
Time Frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
Physical Activity Enjoyment Scale (PACES; Jekauc et al., 2020); higher scores (16 min, 80 max) indicate a better outcome
|
Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
|
Quality Physical Activity (Short Term)
Time Frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
The outcome is a relational aggregate index between leisure time physical activity and occupational physical activity; higher values (i.e., higher leisure time physical activity relative to occupational physical activity) indicate a better outcome; Leisure time physical activity via BSA Questionnaire (Fuchs et al., 2015); Occupational sitting and physical activity questionnaire (OSPAQ; Chau et al., 2012)
|
Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
|
Physical Activity-related Health Competence (Medium Term)
Time Frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
Physical Activity-related Health Competence (PAHCO) Questionnaire (Carl et al., 2020); higher percentage scores (0 min, 100 max) indicate a better outcome
|
Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
|
Psychological Movement Quality (Medium Term)
Time Frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
Physical Activity Enjoyment Scale (PACES; Jekauc et al., 2020); higher scores (16 min, 80 max) indicate a better outcome
|
Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
|
Quality Physical Activity (Medium Term)
Time Frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
The outcome is a relational aggregate index between leisure time physical activity and occupational physical activity; higher values (i.e., higher leisure time physical activity relative to occupational physical activity) indicate a better outcome; Leisure time physical activity via BSA Questionnaire (Fuchs et al., 2015); Occupational sitting and physical activity questionnaire (OSPAQ; Chau et al., 2012)
|
Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
General Health Status (Short Term)
Time Frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
Single-Item (#1) of the Short-Form-Health-Survey (SF-12; Morfeld et al., 2011); after inversion, higher values (0 min, 4 max) will indicate a better outcome
|
Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
|
Work Ability (Short Term)
Time Frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
Work Ability Index, short form (WAI-r; Hetzel et al., 2014); higher values (5 min, 36 max) will indicate a better outcome
|
Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
|
Musculoskeletal Complaints (Short Term)
Time Frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
Ten items (neck/cervical spine, shoulder joints, ellbow/lower arms, hands, thoracic spine, lower back, hip joints/thighs, knee joints, lower legs, feet) of the Nordic Musculosceletal Questionnaire (NMQ; Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, 2021); lower values will indicate a better outcome
|
Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
|
Physical Job Stress in Nursing (Short Term)
Time Frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
Self-developed questionnaire for the physical job stress in nursing; instrument (at its early stage) currently comprises 30 items, will undergo psychometric validation at baseline (T0), lower values (min 0, max 4 for each item) will indicate a better outcome
|
Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
|
|
General Health Status (Medium Term)
Time Frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
Single-Item (#1) of the Short-Form-Health-Survey (SF-12; Morfeld et al., 2011); after inversion, higher values (0 min, 4 max) will indicate a better outcome
|
Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
|
Work Ability (Medium Term)
Time Frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
Work Ability Index, short form (WAI-r; Hetzel et al., 2014); higher values (5 min, 36 max) will indicate a better outcome
|
Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
|
Musculoskeletal Complaints (Medium Term)
Time Frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
Ten items (neck/cervical spine, shoulder joints, ellbow/lower arms, hands, thoracic spine, lower back, hip joints/thighs, knee joints, lower legs, feet) of the Nordic Musculosceletal Questionnaire (NMQ; Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, 2021); lower values will indicate a better outcome
|
Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
|
Physical Job Stress in Nursing (Medium Term)
Time Frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
Self-developed questionnaire for the physical job stress in nursing; instrument (at its early stage) currently comprises 30 items, will undergo psychometric validation at baseline (T0), lower values (min 0, max 4 for each item) will indicate a better outcome
|
Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lorenz E, Grune E, Popp J, Pfeifer K, Carl J. Focus group-supported development and psychometric exploration of an instrument to assess perceived physical exertion in nursing students. BMC Nurs. 2024 Dec 30;23(1):957. doi: 10.1186/s12912-024-02639-9.
- Carl J, Grune E, Popp J, Hartung V, Pfeifer K. Implementation and dissemination of physical activity-related health competence in vocational nursing training: study protocol for a cluster-randomized controlled intervention trial. Trials. 2024 May 15;25(1):322. doi: 10.1186/s13063-024-08153-2.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2023
Primary Completion (Actual)
June 20, 2025
Study Completion (Actual)
July 31, 2025
Study Registration Dates
First Submitted
March 14, 2023
First Submitted That Met QC Criteria
April 4, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K1-2497-GLB-21-V1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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