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Outpatient work-related medical rehabilitation with real workplace training

Outpatient work-related medical rehabilitation with real workplace training - REAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040883
Enrollment
196
Registered
2026-07-07
Start date
2026-08-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M00-M99

Interventions

Group 1: The workplace training program for the intervention group is based on the requirements of the German Pension Insurance and was modified for implementation at the participant’s own workplace.

Sponsors

Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Rehabilitants with a musculoskeletal disorder (ICD-10 codes M00–M99) who are currently employed and require work-related treatment or are at risk of not returning to work are eligible. Rehabilitation centers assess the risk of impaired vocational reintegration using the Würzburg Screening (=1 point on the Subjective Employment Prognosis scale). In addition, motivation for and a need for a phased return to work must be present or expected at the time of admission, as determined during the initial medical consultation. Furthermore, patients must be willing to participate in workplace training at their own workplace and consider its implementation to be feasible.

Exclusion criteria

Exclusion criteria: Rehabilitants undergoing post-acute rehabilitation, individuals with medical conditions that preclude safe levels of physical exertion (absolute and relative medical contraindications), those meeting workplace-related exclusion criteria, and those with insufficient German language proficiency are excluded. Absolute medical contraindications: Patients with absolute medical contraindications or conditions involving increased risk are excluded from participation. These include acute infections causing systemic symptoms (e.g., fever, severe malaise) as well as acute inflammatory flare-ups of musculoskeletal disorders. In addition, unstable cardiovascular conditions (e.g., unstable angina pectoris, uncontrolled arrhythmias) and severe acute exacerbations of pain with a lack of tolerance to physical exertion are grounds for exclusion. Acute mental health crises characterized by a lack of resilience to stress also constitute a criterion for exclusion. Crisis situations involving a lack of resilience constitute an exclusion criterion. Finally, patients with medical conditions that require close medical monitoring are excluded. The exclusion criteria are assessed during the initial medical interview. Relative medical contraindications: Patients with relative medical contraindications or those in high-risk situations may be included after an individual benefit-risk assessment. These include pain symptoms that have not yet been adequately stabilized and significantly reduced functional capacity, where the appropriate level of exercise intensity is initially unclear. Other factors to consider include dizziness, balance disorders, or unsteady mobility, as well as autonomic stress responses during physical activity. In addition, there may be relevant side effects of medication that affect physical endurance or reaction time, as well as complex comorbidities that increase uncertainty regarding physical capacity. Psychological stressors that increase the likelihood of stress or burnout must also be taken into account in the individual assessment. The evaluation of the relative exclusion criteria takes place during the initial medical consultation and is supplemented by an interdisciplinary assessment if necessary. Workplace-related exclusion criteria: Patients whose workplace cannot be clearly defined or whose job duties cannot be sufficiently described are excluded from participation. Also excluded are cases in which the workplace is not accessible for training or is not organizationally accessible. Other grounds for exclusion include the inability to implement workplace training within the company—for example, due to a lack of opportunities for temporary employment or insufficient coordination within the company—as well as the company’s unwillingness to facilitate temporary workplace training. Finally, patients are excluded if their work involves significant safety risks and a controlled stress test does not appear to be justifiable, such as in jobs with a high risk of accidents where there are insufficient opportunities for accommodation. The assessment of workplace-related exclusion criteria is conducted as part of the social services and medical evaluation.

Design outcomes

Primary

MeasureTime frame
Self-rated work ability; How? Continuous, 0 to 10 points, Work Ability Score (Ilmarinen, 2007); When? Start of workplace training, end of rehabilitation, 3-month follow-up, 12-month follow-up

Secondary

MeasureTime frame
Current sickness absence; How? Binary, yes/no, self-developed; When? Start of workplace training, end of rehabilitation, 3-month follow-up, 12-month follow-up Employment; How? Binary, yes/no, self-developed; When? Start of workplace training, end of rehabilitation, 3-month follow-up, 12-month follow-up Cumulative sickness absence; How? Continuously, 0 to 52 weeks, self-developed; When? Start of workplace training, 12-month follow-up Cumulative sickness absence; How? Continuously, 0 to 13 weeks, self-developed; When? 3-month follow-up Stable employment; How? Binary, yes/no, continuous employment for 4 weeks without sick leave (Kuijer et al. 2012), self-developed; When? 3-month follow-up, 12-month follow-up Subjective prognosis of employment status; How? Continuous, 0 to 3 points, SPE scale (Mittag et al., 2006); When? Start of workplace training, end of rehabilitation, 3-month follow-up, 12-month follow-up Occupational self-efficacy; How? Continuous, 1 to 4 points, BSW-5-Rev (Knipsel et al., 2021); When? Start of workplace training, end of rehabilitation, 3-month follow-up, 12-month follow-up Physical workload; How? Continuous, 0 to 15 points, FEBA (Slesina, 1987); When? Start of workplace training, 3-month follow-up, 12-month follow-up Current health status; How? Continuous, 0 to 10 points, COPSOQ (Nübling et al., 2005); When? Start of workplace training, end of rehabilitation, 3-month follow-up, 12-month follow-up Functional capacity in daily life; How? Continuous, 0 to 10 points, IRES-24 (Wirtz et al., 2005); When? Start of workplace training, end of rehabilitation, 3-month follow-up, 12-month follow-up. Pain; How? Continuous, 0 to 10 points, IRES-24 (Wirtz et al., 2005); When? Start of workplace training, end of rehabilitation, 3-month follow-up, 12-month follow-up. Health-related quality of life; How? Continuous, -0.661 to 1 point, EQ-5D-5L (Herdman et al., 2011); When? Start of workplace training, end of rehabilitation, 3-month follow-up, 12-month

Countries

Germany

Contacts

Public ContactRichard Albers

Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie

richard.albers@uksh.de+4945150051226

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026