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

• ClinicalTrials.gov Identifier: NCT04845074
• Recruitment Status: Recruiting
• First Posted: April 14, 2021
• Last Update Posted: May 10, 2023
• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Tampere University Hospital; Regionshospitalet Viborg, Skive; Aalborg University Hospital; Regionshospitalet Silkeborg; Oslo University Hospital; The Danish Rheumatism Association; Association of Danish Physiotherapists
• Information provided by (Responsible Party): University of Aarhus

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Glenohumeral Osteoarthritis	Procedure: TSA-group; Other: Exercise-group	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis Eligible For Shoulder Arthroplasty: the ProAct Multicenter, Randomized Controlled Trial
• Actual Study Start Date: June 2, 2021
• Estimated Primary Completion Date: November 2025
• Estimated Study Completion Date: November 2035

Arms and Interventions

Arm	Intervention/treatment
Experimental: TSA-group; Surgery	Procedure: TSA-group; Anatomical total shoulder arthroplasty followed by standard rehabilitation.
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.

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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).
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Other Outcome Measures:

1. 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.
2. The 100 mm Visual Analogue Scale. [ Time Frame: Measured immediately before and after each exercise session ]
   Patient reported pain intensity at rest
3. 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.
4. 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.
5. 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).
6. 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).
7. 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.
8. 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.
9. 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
10. 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

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Josefine B. Larsen, MSc; +4526237771; josefinebl@clin.au.dk

Contact: Inger Mechlenburg, Prof.; +4521679062; inger.mechlenburg@clin.au.dk

Locations

Denmark

Aarhus University Hospital; Recruiting

Aarhus, Denmark, 8200

Contact: Josefine Larsen, Msc josefinebl@clin.au.dk

Contact: Inger Mechlenburg, Prof. inger.mechlenburg@clin.au.dk

Sub-Investigator: Theis M Thillemann, PhD, As Prof

Aalborg University Hospital; Recruiting

Farsø, Denmark, 9640

Contact: Steen L Jensen

Silkeborg Regional Hospital; Recruiting

Silkeborg, Denmark, 8600

Contact: Brian Elmegaard

Contact: Stine J Due

Viborg Regional Hospital; Recruiting

Viborg, Denmark, 8800

Contact: Helle K Østergaard

Contact: Srdjan Zivanovic

Finland

Tampere University Hospital; Not yet recruiting

Tampere, Finland, 33521

Contact: Antti P. Launonen, PhD, As Prof antti.launonen@pshp.fi

Norway

Oslo University Hospital; Recruiting

Oslo, Norway, 4956

Contact: Berte Bøe

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

Tampere University Hospital

Regionshospitalet Viborg, Skive

Aalborg University Hospital

Regionshospitalet Silkeborg

Oslo University Hospital

The Danish Rheumatism Association

Association of Danish Physiotherapists

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04845074
• Other Study ID Numbers: PROACT
• First Posted: April 14, 2021
• Last Update Posted: May 10, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code
• Time Frame: Data will be available after publication of the trial.
• Access Criteria: Data access will be reviewed by the author group. Requestors will be required to sign a Data Access Agreement.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:

Physiotherapist-supervised Exercise; Physical Therapy; Physical Rehabilitation; Anatomical total shoulder arthroplasty; Randomized Controlled Trial

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases