NCT06594120

Brief Summary

The objective of this observational study is to gain insight into a new approach to rehabilitation in Austria, with a particular focus on work-specific exercises that are dependent on the specific work-related needs of the patients. Two groups are being observed: one was referred to a three-week work-specific rehabilitation programme immediately upon arrival at the rehabilitation centre, while the other group underwent a three-week medical-focused rehabilitation programme before starting a four-week work-specific rehabilitation programme. Researchers will monitor for indications of improvement following completion of the rehabilitation program. As the two forms of rehabilitation are not directly comparable, they will be observed and analysed as two distinct entities. As part of their regular inpatient rehabilitation, participants will complete questionnaires at designated intervals (beginning and end of stay), with follow-up assessments scheduled at six and 12 months post-rehabilitation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Aug 2024Oct 2026

Study Start

First participant enrolled

August 22, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 10, 2025

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 10, 2024

Last Update Submit

March 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • IMBA - Profile comparison

    IMBA is a profile comparison method for prevention and rehabilitation. Job requirements and human capabilities are described by standardised, defined characteristics and compared directly with each other. The respective profile sheets consist, among other things, of 70 function-, activity- and context-related main characteristics in which the extent of excessive demands for each characteristic is documented on a scale of 0 - 6 (Min. = 0, Max = 420). Lower values indicate less excessive demands.

    3 or 4 weeks of inpatient rehabilitation

  • Employment history

    The existence of gainful employment subject to social insurance contributions in a specific period allows conclusions to be drawn about the employment history of the rehabilitants.

    6 and 12 months after finishing rehabilitation

Secondary Outcomes (3)

  • Work ability index (WAI)

    3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation

  • Patient Health Questionnaire-4 (PHQ-4)

    3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation

  • European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)

    3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation

Study Arms (2)

3-week work-specific rehabilitation

This group is referred to the work-specific rehabilitation programme immediately upon arrival at the rehabilitation centre.

Behavioral: Multimodal rehabilitation with additional work specific training

4-week work-specific rehabilitation

This group first underwent a three-week medical-focused rehabilitation programme prior to commencing the work-specific rehabilitation programme.

Behavioral: Multimodal rehabilitation with additional work specific training

Interventions

The rehabilitation is based on the biopsychosocial ICF model of the WHO. Taking into account the physical and psychological condition of the patients, an individual therapy plan is created that is tailored to the needs of the patients.

3-week work-specific rehabilitation4-week work-specific rehabilitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with specific work-related rehabilitation needs

You may qualify if:

  • The study participants are regular patients in the rehabilitation centre Bad Hofgastein
  • Presence of a disease in the area of the musculoskeletal system
  • Sufficient motivation to maintain professional participation
  • Declaration of consent

You may not qualify if:

  • No completion of all work-specific rehabilitation modules
  • Acute or decompensated disease states with severe functional limitations (i.e. not able to continue with the rehabilitation programme)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitationszentrum Bad Hofgastein

Bad Hofgastein, Salzburg, 5630, Austria

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Doreen Stöhr, Mag.

    Pensionsversicherungsanstalt

    STUDY CHAIR

Central Study Contacts

Stefan Gschwenter, MA

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

August 22, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 10, 2025

Record last verified: 2024-09

Locations