EmployabilitySPIRONCT03206307
Spiroergometric and Psychological Measurements to Predict Return to Work After 18 and 36 Months After Medical Rehab
An observational study of Employability, run by Jacobs University Bremen gGmbH at 1 site in Germany.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Employability
- How many people
- 284 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2016to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Insufficient knowledge of the German language
- No participation in the spiroergometrical measurement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spiroergometrische Und Psychologische Messungen Zur Vorhersage Der Erwerbsfähigkeit Und Rückkehr Zur Arbeit Nach 18 Und 36 Monaten Nach Der Medizinischen Rehabilitation
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?
Read the detailed description
One main aim of medical rehabilitation is to restore ability to work. The goal is to increase health, as well as the performance and functional capacity of the the rehabilitant, in order to improve their occupational ability, as well as social activity and participation.
A number of the psychological and structural factors involved in this are already known. There is less evidence, however, regarding the importance of objectively measured performance and functioning, as well as the relation of these objective measures with subjective factors (i.e., the interaction of cardiovascular performance and physical activity with psychological factors with).
Therefore, this study investigates how rehabilitants can successfully decrease their professional vulnerability, and the importance of spiroergometric and psychological data to predict viability and return to work.
The aim is to improve the theorised variance in predicting the viability and return to work and, based on the results, to make appropriate recommendations to those affected and their social network, rehabilitation facilities, those offering rehabilitation services, employers and physicians.
The following research questions are to be answered with this study:
- Can spiroergometric data and psychological mechanisms characterize: (A) workability and physical activity, (B) self assessment of the professional future, (C) return to working life, (D) ability to deal with occupational burdens (professional capacity) ... 6, 12, 18 and 36 months after medical rehabilitation?
- What is the significance of objective data compared to subjective characteristics (such as "higher level goals" in terms of employment), and how are the mediating psychological mechanisms involved?
In rehabilitation patients with degenerative skeletal diseases, a spiroergometry measurement (cardiovascular checkup) was carried out in 2013/2014 (group 1, G1). This study determined the performance of the cardiovascular system and the general "fitness". The patients were also questioned about age, workload, work satisfaction, assessment of the future of the profession and accompanying psychological stress.
A follow-up survey of those who are insured is to be carried out by telephone.
In addition, new patients (group 2, G2) are to be interviewed and spiroergometrically tested, as well as to be interviewed three times over the phone.
This will allow: (1) analyzing the change over time and the cardiovascular capacity beyond psychological factors (motivation, self-efficacy) and physical activity, (2) comparisons with other insured persons.
Data collection after rehabilitation is carried out as a computer-assisted telephone interview, and is conducted after the rehabilitation after 6, 12, 18 (G2) and 36 months (G1).
- Conditions
- Employability
- Keywords
- Return to work, medical rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen absorption during stress test
Measured by VO2MAX (maximum oxygen consumption in ml / kg body weight / min)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Parameters include personal reasons to safeguard earning capacity: money, feeling needed, interpersonal contact, recognition, knowledge/experience, fun, routine, development, mentally fitness, being outside the home, purpose in life, expectations from others, physical fitness, distraction from other problems
Measured: 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
Parameters include personal objectives to achieve from rehabilitation: improved mobility, improved physical condition, improved physical illness and complaints, improved mental condition, improved interpersonal situation, improved professional situation, improved working capacity, weight loss, pain reduction, overall health promotion, deal with daily stress, more confidence
Measured: 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
Parameters include: perceived job security, earning capacity risk, satisfaction with life, satisfaction with job-related activities, satisfaction with physical activity, social support, self-efficacy
Measured: 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
Parameters include participation in: medical treatments, psychological therapies, disease-specific group training, physical therapy, movement therapy, general health training, work-related measures, professional advice, relaxation techniques
Measured: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Oct 2016
- Primary completion30 Sep 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmployabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobs University Bremen gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia Lippke, Prof. Dr., Principal investigator, Jacobs University Bremen gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206307
- Sponsor's protocol ID
- 060.001.12.00 - 3.050
- Acronym
- SPIRO
- Status last verified
- Feb 2019
- First submitted
- 8 Jun 2017
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IPD sharing plan.
Publications
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.
PubMed 32345071
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spiroergometrische Und Psychologische Messungen Zur Vorhersage Der Erwerbsfähigkeit Und Rückkehr Zur Arbeit Nach 18 Und 36 Monaten Nach Der Medizinischen Rehabilitation
- ClinicalTrials.gov ID
- NCT03206307
- Acronym / sponsor ID
- SPIRO / 060.001.12.00 - 3.050
- Conditions
- Employability
- Keywords
- Return to work, medical rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Jacobs University Bremen gGmbHUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
One main aim of medical rehabilitation is to restore ability to work. The goal is to increase health, as well as the performance and functional capacity of the the rehabilitant, in order to improve their occupational ability, as well as social activity and participation.
A number of the psychological and structural factors involved in this are already known. There is less evidence, however, regarding the importance of objectively measured performance and functioning, as well as the relation of these objective measures with subjective factors (i.e., the interaction of cardiovascular performance and physical activity with psychological factors with).
Therefore, this study investigates how rehabilitants can successfully decrease their professional vulnerability, and the importance of spiroergometric and psychological data to predict viability and return to work.
The aim is to improve the theorised variance in predicting the viability and return to work and, based on the results, to make appropriate recommendations to those affected and their social network, rehabilitation facilities, those offering rehabilitation services, employers and physicians.
The following research questions are to be answered with this study:
- Can spiroergometric data and psychological mechanisms characterize: (A) workability and physical activity, (B) self assessment of the professional future, (C) return to working life, (D) ability to deal with occupational burdens (professional capacity) ... 6, 12, 18 and 36 months after medical rehabilitation?
- What is the significance of objective data compared to subjective characteristics (such as "higher level goals" in terms of employment), and how are the mediating psychological mechanisms involved?
In rehabilitation patients with degenerative skeletal diseases, a spiroergometry measurement (cardiovascular checkup) was carried out in 2013/2014 (group 1, G1). This study determined the performance of the cardiovascular system and the general "fitness". The patients were also questioned about age, workload, work satisfaction, assessment of the future of the profession and accompanying psychological stress.
A follow-up survey of those who are insured is to be carried out by telephone.
In addition, new patients (group 2, G2) are to be interviewed and spiroergometrically tested, as well as to be interviewed three times over the phone.
This will allow: (1) analyzing the change over time and the cardiovascular capacity beyond psychological factors (motivation, self-efficacy) and physical activity, (2) comparisons with other insured persons.
Data collection after rehabilitation is carried out as a computer-assisted telephone interview, and is conducted after the rehabilitation after 6, 12, 18 (G2) and 36 months (G1).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Insufficient knowledge of the German language
- No participation in the spiroergometrical measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxygen absorption during stress test
Time frame: 6 months
Measured by VO2MAX (maximum oxygen consumption in ml / kg body weight / min)
Workability, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
Parameters include health status, employment history, current position, working hours, physical, mental or emotional restrictions to work
Job satisfaction, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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
Personal appraisal of the professional future, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
Parameters include whether individual expects future work difficulties professionally and/or due to health restrictions
Return to working life, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
Parameters include how many hours individual desires to work again
The handling of occupational burdens, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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
4 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Derived from this study: PubMed 32345071Rinn 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.
- Individual participant dataSharing planned: No. There is no IPD sharing plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Lippke, Prof. Dr. principal investigator
Jacobs University Bremen gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Employability, run by Jacobs University Bremen gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen absorption during stress test (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03206307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.