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Completed

NCT Number: NCT03206307

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

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?

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jacobs University Bremen gGmbH

Bremen, 28759, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Oxygen absorption during stress test

    Time frame: 6 months

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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Jacobs University Bremen gGmbH

Other

Registry information

Official study title

Spiroergometrische Und Psychologische Messungen Zur Vorhersage Der Erwerbsfähigkeit Und Rückkehr Zur Arbeit Nach 18 Und 36 Monaten Nach Der Medizinischen Rehabilitation

Acronym: SPIRO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2017
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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