Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis (PROACT)

June 7, 2024 updated by: University of Aarhus

Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis Eligible For Shoulder Arthroplasty: the ProAct Multicenter, Randomized Controlled Trial

Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral osteoarthritis. The primary aim of this trial is to examine if TSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with primary glenohumeral OA eligible for unilateral TSA. We hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (18-point, on a scale from 0-100) improvement compared to the exercise intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Glenohumeral osteoarthritis causes pain, stiffness and weakness in the shoulder joint, and furthermore, it affects activities of daily living and quality of life. Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. Several studies have suggested the need for trials comparing shoulder arthroplasty to non-surgical treatments.

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.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
      • Esbjerg, Denmark, 6700
        • Recruiting
        • Esbjerg Hospital
        • Contact:
          • Klaus Hanisch
      • Farsø, Denmark, 9640
        • Recruiting
        • Aalborg University Hospital
        • Contact:
          • Steen L Jensen
      • Silkeborg, Denmark, 8600
        • Recruiting
        • Silkeborg Regional Hospital
        • Contact:
          • Brian Elmegaard
        • Contact:
          • Stine J Due
      • Viborg, Denmark, 8800
        • Recruiting
        • Viborg Regional Hospital
        • Contact:
          • Helle K Østergaard
        • Contact:
          • Srdjan Zivanovic
  • Finland
      • Tampere, Finland, 33521
        • Not yet recruiting
        • Tampere University Hospital
        • Contact:
  • Norway
      • Oslo, Norway, 4956
        • Recruiting
        • Oslo University Hospital
        • Contact:
          • Berte Bøe

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

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ≥55-85 years
  • 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:

  • Surgical need for bonegraft
  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise-group
Exercise
Other: 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.
Experimental: TSA-group
Surgery
Procedure: TSA-group
Anatomical total shoulder arthroplasty followed by standard rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
Time Frame: Measured at 12-month follow-up
WOOS consist of 19 items to be answered using a visual analog scale (VAS). Each item has a possible score ranging from 0 to 100, leading to a total WOOS score ranging from 0 to 1900, with 0 being the best. For simplicity reasons, raw scores can be converted to a percentage of the maximum score (0-100, 100 best).
Measured at 12-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
Time Frame: Measured at baseline, 12-week, 2-, 5- and 10-year follow-up
WOOS consist of 19 items to be answered using a visual analog scale (VAS). Each item has a possible score ranging from 0 to 100, leading to a total WOOS score ranging from 0 to 1900, with 0 being the best. For simplicity reasons, raw scores can be converted to a percentage of the maximum score (0-100, 100 best).
Measured at baseline, 12-week, 2-, 5- and 10-year follow-up
Serious Adverse Events
Time Frame: The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge.
Serious adverse events are defined as embolism (cardiac or brain), death, liver and renal failure.
The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge.
Adverse events
Time Frame: Occurring during the period from inclusion until the 12-month follow-up
Defined as any unintended and unfavorable sign, symptom or disease resulting in contact with the healthcare system irrespective of a causal relationship with the intervention and outcome assessments.
Occurring during the period from inclusion until the 12-month follow-up
Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
DASH is a self-administered questionnaire that consist of thirty core items and eight items assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, and lower scores correlated to minimal impairments and higher scores indicate more impairment. The cumulative DASH score is scaled from 0-100 with higher scores indicating more disability.
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
The 100 mm Visual Analogue Scale.
Time Frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Patient reported pain intensity at rest, during activity and nightly pain.
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
The use of analgesics during the last week
Time Frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
They will be asked if they take any analgesics, which type they take (paracetamol, NSAID, morphine/opioids) and how often they consume the medication.
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Failure
Time Frame: Measured at 12-month, 2-, 5- and 10-year follow-up.
Patient-reported treatment failure will be assessed only by patients answering "no" to PASS with the following question: "Would you consider your current state as being so unsatisfactory that you think the treatment has failed?" on a dichotomous scale (yes/no).
Measured at 12-month, 2-, 5- and 10-year follow-up.
Number of total shoulder arthroplasty surgeries (exercise-group)
Time Frame: Measured from baseline to 12-month, 2-, 5- and 10-year follow-up.
Number of total shoulder arthroplasty surgeries performed in the exercise-group.
Measured from baseline to 12-month, 2-, 5- and 10-year follow-up.
Accelerometer-based activity using tri-axial (Axivity, UK) accelerometers
Time Frame: Measured at baseline and 12-month follow-up
The patients will have an accelerometer sensor mounted with tape to both upper arms for 4 days. The sensors will measure 24/7 activity and degree of movement.
Measured at baseline and 12-month follow-up
The 100 mm Visual Analogue Scale.
Time Frame: Measured immediately before and after each exercise session
Patient reported pain intensity at rest
Measured immediately before and after each exercise session
EQ-5D-5L
Time Frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up.
The EuroQol measures the five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each dimension consists of one item, distinguished in five levels.
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up.
Productivity Costs Questionnaire (iPCQ)
Time Frame: Measured at 12-week, 12-month follow-up.
The iPCQ is a questionnaire for the measurement of costs in economic evaluations. It consists of 18 questions of which 9 are general questions followed by questions to measure productivity losses. Measured for the health economic evaluation in Denmark.
Measured at 12-week, 12-month follow-up.
Patient Acceptable Symptom State (PASS)
Time Frame: Measured at 12-month, 2-, 5- and 10-year follow-up.
PASS will be assessed with the following question: "When you think of your shoulder function, will you consider your current condition as satisfying?" By shoulder function, you should take into account your activities of daily living, sport and recreational activities, your shoulder pain and other symptoms and your quality-of-life on a dichotomous scale (yes/no).
Measured at 12-month, 2-, 5- and 10-year follow-up.
Number of supervised exercise sessions from baseline to 3 months (exercise-group)
Time Frame: From baseline to 12 weeks
High compliance will be defined as participation in ≥70% of the training sessions; moderate compliance as participation in 50-70% of the sessions; and poor compliance as participation in <50% of the sessions.
From baseline to 12 weeks
Number of patients performing unsupervised exercise (exercise-group)
Time Frame: From baseline to 12 weeks
Adherence to two weekly unsupervised exercise sessions will be measured by a patient-reported questionnaire
From baseline to 12 weeks
Number of patients performing unsupervised exercise (exercise-group)
Time Frame: From 12 weeks to 12 months
Adherence to optional unsupervised exercise sessions will be measured by a patient-reported questionnaire
From 12 weeks to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Oslo University Hospital
Aarhus University Hospital
Aalborg University Hospital
Tampere University Hospital
Regionshospitalet Viborg, Skive
Association of Danish Physiotherapists
The Danish Rheumatism Association
Regionshospitalet Silkeborg
Esbjerg Hospital

Investigators

  • Principal Investigator: Josefine B. Larsen, MSc, Aarhus University Hospital and Aarhus University
  • Study Director: Inger Mechlenburg, Prof., Aarhus University Hospital and Aarhus University
  • Study Director: Theis M. Thillemann, PhD, As Prof, Aarhus University Hospital and Aarhus University
  • Study Director: Antti P. Launonen, PhD, As Prof, Tampere University Hospital

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.

General Publications

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)

June 2, 2021

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2035

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pseudo anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.

IPD Sharing Time Frame

Data will be available after publication of the trial.

IPD Sharing Access Criteria

Data access will be reviewed by the author group. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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