Spiroergometric and Psychological Measurements to Predict Return to Work After 18 and 36 Months After Medical Rehab (SPIRO)

February 26, 2019 updated by: Jacobs University Bremen gGmbH

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?

Study Overview

Status

Completed

Conditions

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:

  1. 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?

  2. 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 Type

Observational

Enrollment (Actual)

284

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

      • Bremen, Germany, 28759
        • Jacobs University Bremen gGmbH

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen absorption during stress test
Time Frame: 6 months
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
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
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
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
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
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
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
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
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
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
After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
Parameters include: perceived job security, earning capacity risk, satisfaction with life, satisfaction with job-related activities, satisfaction with physical activity, social support, self-efficacy
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)
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
After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)

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.

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)

October 1, 2016

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

December 30, 2018

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (ACTUAL)

July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 060.001.12.00 - 3.050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no IPD sharing plan.

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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