NCT03206307

Brief Summary

Can professional performance and the probability of returning to work up to three years after medical rehabilitation be predicted by spiroergometric data (or performance of the cardiovascular system) together with psychological factors (motivation, self-efficacy) as well as physical activity, and their interaction? How are work related and health related factors associated with the The following variables: workload, work satisfaction, personal assessment of the professional future and psychological stress?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

June 8, 2017

Last Update Submit

February 26, 2019

Conditions

Keywords

Return to workmedical rehabilitation

Outcome Measures

Primary Outcomes (6)

  • Oxygen absorption during stress test

    Measured by VO2MAX (maximum oxygen consumption in ml / kg body weight / min)

    6 months

  • Workability, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation

    Parameters include health status, employment history, current position, working hours, physical, mental or emotional restrictions to work

    After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

  • Job satisfaction, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation

    Parameters include earning capacity, whether job is mentally/physically/emotionally/inter-personally exhausting, skills required, whether recognition is received, independence, boring/challenging , overwhelming, continuous learning, whether important to the person

    After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

  • Personal appraisal of the professional future, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation

    Parameters include whether individual expects future work difficulties professionally and/or due to health restrictions

    After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

  • Return to working life, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation

    Parameters include how many hours individual desires to work again

    After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

  • The handling of occupational burdens, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation

    Parameters include personal initiatives to make return to work practical: changing working conditions, reduction in work hours, different position, professional training, attended health promoting courses, attended coaching/counseling, engaged in self-help, lifestyle changes

    After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

Secondary Outcomes (4)

  • Plans to participate and wishes to take measures to safeguard the earning capacity, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation

    After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

  • Self-imposed objectives and achievement, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation

    After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

  • Personal, social and contextual factors, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation

    After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

  • Participation in interventions, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation

    After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

Study Arms (2)

Group 1

Group 1 will be questioned 36 months (in 2017) after their medical rehabilitation which was in 2013/2014.

Group 2

Group 2 has the medical rehabilitation in 2017 and will be questioned at the end of the medical rehabilitation and 6, 12 and 18 months after that

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In the study insured members of the Deutsche Rentenversicherung Oldenburg-Bremen with a granted medical rehabilitation treatment at the Montanus-Klinik Bad Schwalbach will be asked to fill out a questionnaire when arriving at the rehabilitation clinic as well as to take part in three subsequent telephone interviews after 6,12 and 18 months.

You may qualify if:

  • Degenerative skeletal disease
  • Medical rehabilitation at Montanus-Klinik Bad Schwalbach
  • Insured with the Deutsche Rentenversicherung Oldenburg-Bremen
  • Sufficient knowledge of the German language
  • Telephone or mobile phone connection

You may not qualify if:

  • Insufficient knowledge of the German language
  • No participation in the spiroergometrical measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacobs University Bremen gGmbH

Bremen, 28759, Germany

Location

Related Publications (1)

  • Rinn R, Gan Y, Whittal A, Lippke S. Cardiopulmonary capacity and psychological factors are related to return to work in orthopedic rehabilitation patients. J Health Psychol. 2021 Nov;26(13):2505-2519. doi: 10.1177/1359105320913946. Epub 2020 Apr 28.

Study Officials

  • Sonia Lippke, Prof. Dr.

    Jacobs University Bremen gGmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2017

First Posted

July 2, 2017

Study Start

October 1, 2016

Primary Completion

September 30, 2018

Study Completion

December 30, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

There is no IPD sharing plan.

Locations