Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis
NCT ID: NCT04845074
Last Updated: 2025-04-15
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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ACTIVE_NOT_RECRUITING
NA
102 participants
INTERVENTIONAL
2021-06-02
2035-11-30
Brief Summary
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Detailed Description
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The ProAct trial is a Nordic multicenter randomized controlled trial. Patients with glenohumeral osteoarthritis, eligible for a TSA will be randomised to either TSA followed by usual care or exercise only. The exercise intervention consists of 12 weeks of exercise with one weekly physiotherapist-supervised exercise session.
The primary outcome will be the total the Western Ontario Osteoarthritis of the Shoulder index score at 12 months follow-up.Outcome assessment will be performed at baseline, and at 3 and 12 months and 2-, 5- and 10 years after start of surgical/non-surgical treatment.
Patients fulfilling the eligibility criteria but declining to participate in the randomised trial will be offered the option of participating in an observational cohort using the same primary end point and patient reported outcomes, but following usual clinical practice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TSA-group
Surgery
TSA-group
Anatomical total shoulder arthroplasty followed by standard rehabilitation.
Exercise-group
Exercise
Exercise-group
The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.
Interventions
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TSA-group
Anatomical total shoulder arthroplasty followed by standard rehabilitation.
Exercise-group
The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.
Eligibility Criteria
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Inclusion Criteria
* Moderate-severe primary OA of the glenohumeral joint according to Samilson and Prieto, by measuring the lower osteophyte (32)
* Eligible for surgery with standard TSA
Exclusion Criteria
* Previous shoulder fracture (fracture of the proximal humerus or glenoid fracture)
* Planned other upper extremity surgery within six months
* Rheumatoid arthritis or other types of arthritis not diagnosed as primary glenohumeral OA
* Cancer diagnosis and receiving chemo-, immuno- or radiotherapy
* Neurological diseases affecting shoulder mobility (e.g. disability after previous stroke, multiple sclerosis, Parkinson's, Alzheimer's disease)
* Other reasons for exclusion (i.e. mentally unable to participate) or planned absence for more than 14 days in the first 3 months after baseline test.
* Unable to communicate in the participating countries respective languages
55 Years
85 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Tampere University Hospital
OTHER
Regionshospitalet Viborg, Skive
OTHER
Aalborg University Hospital
OTHER
Regionshospitalet Silkeborg
OTHER
Oslo University Hospital
OTHER
The Danish Rheumatism Association
OTHER
Association of Danish Physiotherapists
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Josefine B. Larsen, MSc
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital and Aarhus University
Inger Mechlenburg, Prof.
Role: STUDY_DIRECTOR
Aarhus University Hospital and Aarhus University
Theis M. Thillemann, PhD, As Prof
Role: STUDY_DIRECTOR
Aarhus University Hospital and Aarhus University
Antti P. Launonen, PhD, As Prof
Role: STUDY_DIRECTOR
Tampere University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Esbjerg Hospital
Esbjerg, , Denmark
Aalborg University Hospital
Farsø, , Denmark
Silkeborg Regional Hospital
Silkeborg, , Denmark
Viborg Regional Hospital
Viborg, , Denmark
Tampere University Hospital
Tampere, , Finland
Oslo University Hospital
Oslo, , Norway
Countries
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References
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Beck Larsen J, Thillemann TM, Launonen AP, Ostergaard HK, Falstie-Jensen T, Reito A, Lund Jensen S, Mechlenburg I. Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial. Acta Orthop. 2022 Feb 8;93:303-316. doi: 10.2340/17453674.2022.2043.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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PROACT
Identifier Type: -
Identifier Source: org_study_id
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