Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery
NCT ID: NCT06868472
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
84 participants
INTERVENTIONAL
2025-03-18
2029-02-28
Brief Summary
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• Does prehabilitation before elective shoulder surgeries lead to an improvement in postoperative outcomes and patient satisfaction compared to the control group?
The control group receives standard information about the hospital stay, while the intervention group undergoes the prehabilitation program in the approximately 6 weeks prior to surgery. This program includes:
* Information on the condition and pain management
* Recommendations for behavior modification
* A home exercise program Primary endpoint is the Western Ontario Rotator Cuff Index (WORC). The assessments are conducted at four time points: at study enrollment, immediately before surgery, and at 6, 12, and 24 months after surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Prehabilitation-Group
Prehabilitation
The waiting time until the operation is about 6 weeks. The intervention is carried out during this time:
The intervention group receives a brochure with an evidence-based exercise program for the shoulder and shoulder girdle. The brochure contains pages in which the patient documents how the exercises are carried out. The exercise program is supplemented by information in the form of a video/Power Point presentation on: Anatomy/function, pain management, hospitalization and subsequent rehabilitation.
After 2 and after 4 weeks, the physiotherapist who has explained the exercise program will contact you by telephone/zoom.
Control-Group
Control
The control group receives a leaflet with general information for the period up to the operation (e.g. buy water-resistant plasters, arrange post-op physiotherapy appointments).
Interventions
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Prehabilitation
The waiting time until the operation is about 6 weeks. The intervention is carried out during this time:
The intervention group receives a brochure with an evidence-based exercise program for the shoulder and shoulder girdle. The brochure contains pages in which the patient documents how the exercises are carried out. The exercise program is supplemented by information in the form of a video/Power Point presentation on: Anatomy/function, pain management, hospitalization and subsequent rehabilitation.
After 2 and after 4 weeks, the physiotherapist who has explained the exercise program will contact you by telephone/zoom.
Control
The control group receives a leaflet with general information for the period up to the operation (e.g. buy water-resistant plasters, arrange post-op physiotherapy appointments).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Prof. Arasch Wafaisade
OTHER
Responsible Party
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Prof. Arasch Wafaisade
Prof. Dr. med.
Locations
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Kliniken der Stadt Köln gGmbH
Cologne, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Ethics number: 150/2024
Identifier Type: -
Identifier Source: org_study_id
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