Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000779471
Ethics application status
Approved
Date submitted
7/06/2016
Date registered
15/06/2016
Date last updated
17/07/2019
Date data sharing statement initially provided
17/07/2019
Date results information initially provided
17/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise rehabilitation and functional recovery following reverse total shoulder arthroplasty
Scientific title
Exercise rehabilitation and functional recovery following reverse total shoulder arthroplasty in patients with massive rotator cuff tears
Secondary ID [1] 289304 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Massive rotator cuff tear 298895 0
Glenohumeral joint osteoarthrosis, with or without rotator cuff dysfunction 313697 0
Condition category
Condition code
Musculoskeletal 298973 298973 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 299102 299102 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research is a prospective randomised control trial (RCT) investigating the benefit of a structured postoperative exercise rehabilitation program in patients undergoing reverse shoulder arthroplasty (RSA). The purpose of this study is to investigate the capacity in which structured post-surgery exercise programs can improve patient strength, active range of motion (AROM) and early functional recovery after RSA, compared with control subjects who receive the usual course of care.

Following RSA surgery, patients will be placed in an immobilisation sling for 4 to 6 weeks and instructed to adhere strictly to the activity restrictions set by their surgeon. All patients will be educated on optimal management for reducing pain and/or swelling, as well as safely removing and fitting of the sling and clothing, and all contraindications and precautions associated with the surgical procedure. In-patient exercises will focus on safe passive range of motion (PROM) of the shoulder, as well as AROM of the hand, wrist and elbow. As mentioned above, these exercises will also be developed into a home exercise program (HEP) for patients to continue with in the comfort of their home.

Following hospital discharge, all patients are followed up by their respective surgeon 2 weeks’ post-surgery to tend to the surgical wound, and then again at 6 weeks’ post-surgery for routine follow-up. From the 2-week time point, patients randomised to the usual management group (UM) will receive routine mobility exercises aimed at progressing their shoulder movement. Patients randomised to the DARE exercise group will receive these same standard exercises, with additional light, submaximal muscle contractions around the shoulder to boost early strength. These include sub-maximal isometric contractions of the deltoid and external rotators lasting 10 seconds, and for 1 set of 10 repetitions, and advanced passive flexion and external rotation ROM exercises, again for 1 set of 10 repetitions. Patients will be required to complete these home-exercises two to three times daily, lasting for approximately 30 minutes up until the 6-week time point.

At the 6-week time-point, after the patients a reviewed by their surgeon and have their immobilisation sling removed, patients in each both groups will have their exercises progressed accordingly, to include active-assisted exercises using a pulley, and a wall to assist with elevation, consistent with standard practice. In addition, the DARE group will undertake exercises aimed at improving external rotation using a Thera-band, and active elevation exercises starting supine and progressing (managed by the patient themselves) gradually into upright as tolerated. Each exercise will be prescribed for 2 sets of 10-15 repetitions, unless modified at the discretion of the Exercise Physiologist, or the treating surgeon. Patients will be required to complete these home-exercises twice daily, lasting for approximately 30 minutes up until the 12-week time point. Patients will all receive a “post-surgery home exercise guide” as a reference, but also acting as a patient diary to record all exercises done over the 12 weeks. All patients will continue to be monitored throughout the post-surgery timeline, irrespective of the group they have been assigned.

At 12-weeks post-surgery, patients randomised to the DARE group will be referred to the Clinic (HFRC), to begin an 8-week supervised, strengthening exercise program, consisting of 30 to 60-minute sessions, once or twice per week. This program of intensified strength and conditioning will look to advance deltoid and internal, and external rotator strength to improve functional elevation & active rotation, as well as scapula stability training and cardiovascular exercise under the supervision of an Exercise Physiologist. Patients will also be required to complete daily home exercises, which will again be referenced in the “post-surgery home exercise guide.”
Intervention code [1] 294861 0
Rehabilitation
Comparator / control treatment
Following RSA surgery, patients will be placed in an immobilisation sling for 4 to 6 weeks and instructed to adhere strictly to the activity restrictions set by their surgeon. All patients will be educated on optimal management for reducing pain and/or swelling, as well as safely removing and fitting of the sling and clothing, and all contraindications and precautions associated with the surgical procedure. In-patient exercises will focus on safe passive range of motion (PROM) of the shoulder, as well as AROM of the hand, wrist and elbow. As mentioned above, these exercises will also be developed into a home exercise program (HEP) for patients to continue with in the comfort of their home.

Following hospital discharge, all patients will return to SJOG Hospital 2 weeks’ post-surgery to consult with their surgeon to tend to the surgical wound, and then again at 6 weeks’ post-surgery for routine follow-up. Patients randomised to the Usual Management (UM) group will have their immobilisation sling removed, receive exercises to complete two to three times daily, lasting approximately 15 to 20 minutes, as per the standard care of the operating surgeon deemed appropriate at the time of evaluation. Patients will continue without specific intervention but will, however, continue to be monitored throughout the post-surgery timeline.

Furthermore, a control group consisting of thirty “apparently healthy” participants will also be included into this study, as a "comparative group" for normal upper limb function assessed with body-worn activity monitors. All control group participants are required to have no upper extremity injury at the time of testing, no symptoms in either upper extremity, and no history of shoulder surgery to either arm. As described in the outcomes section of this study, this "apparently healthy group" , this group will be required to attend two testing sessions within four days at the School of Sport Science, Exercise and Health at the University of Western Australia, to be fitted with five body-worn activity monitors (ActiGraph GT9X+ Link, ActiGraph, Pensacola, FL). These activity monitors will be secured on both upper arms at the mid-biceps, the lower arms at the wrist, and on the waist. Activity data will be collected over three consecutive days while these participants go about their usual routine and activities of daily living. After activity data collection, participants will complete validated upper limb questionnaires such as the American Shoulder and Elbow Surgeons evaluation form (ASES). An activity participation questionnaires used in previous studies will also be required to be completed.
Control group
Active

Outcomes
Primary outcome [1] 298443 0
American Shoulder and Elbow Surgeons Questionnaire (ASES)
Timepoint [1] 298443 0
Baseline, pre-surgery, 3-, 6-, and 12 months post-surgery.
Secondary outcome [1] 324141 0
The Australian Quality of Life Scale (AQoL)
Timepoint [1] 324141 0
Baseline, pre-surgery, 3-, 6-, and 12 months post-surgery
Secondary outcome [2] 324142 0
Constant-Murley (CM) Score
Timepoint [2] 324142 0
Baseline, pre-surgery, 3-, 6-, and 12 months post-surgery
Secondary outcome [3] 324638 0
Upper limb activity data

Functional limb activity will be measured using five ActiGraph GT9X+ Link (ActiGraph, Pensacola, FL) activity monitors secured bilaterally to the upper arms at the mid-biceps, the lower arms at the wrist, and on the waist of each participant, including healthy volunteers, as per previous recommendations. Activity data will be collected over three consecutive days in patients’ natural living environment, but not including time spent sleeping. The vector magnitude (VM) physical of activity counts from each accelerometer will be calculated with ActiLife software (ActiGraph, Pensacola, FL). The ActiLife VM physical activity counts will be exported to an Excel spreadsheet using 1-second epochs for every second during the entire data collection. The average activity for each limb segment will be determined each day by calculating the arithmetic mean of the epoch activity value within 1 day for each subject. A within-subject average activity value will subsequently be calculated for each limb segment over the 3 days of collection. Novel techniques previously described and validated in the literature will be applied to determine limb asymmetries and activity intensities.
Timepoint [3] 324638 0
For patients, data will be collected at baseline, pre-surgery, 3-, 6- and 12 months’ post-surgery.

For healthy volunteers, data will be collected once at baseline.
Secondary outcome [4] 372726 0
Shoulder Activity Survey (SAS)
Timepoint [4] 372726 0
Pre-surgery and 12 months post-surgery
Secondary outcome [5] 372727 0
Visual Analog Scale (VAS) Pain
Timepoint [5] 372727 0
Pre-surgery, 3-, 6- and 12 months post-surgery
Secondary outcome [6] 372728 0
Visual Analog Scale (VAS) Function
Timepoint [6] 372728 0
Pre-surgery, 3-, 6- and 12 months post-surgery
Secondary outcome [7] 372729 0
Single Assessment Numeric Evaluation (SANE)
Timepoint [7] 372729 0
Pre-surgery, 3-, 6- and 12 months post-surgery

Eligibility
Key inclusion criteria
For patients:

1.) Male or female, between 55 and 85 years and local to the Perth metropolitan area
2.) Patients with a massive rotator cuff tear, with or without arthropathy, subsequently scheduled for RSA
3.) Pseudoparalysis of the affected shoulder, including forward elevation <90 degrees

For healthy volunteers:

1.) Between the 55 and 85 years of age, to best match to intervention patients with respect to age and gender
2.) No upper extremity injury at the time of testing
3.) No symptoms in either upper extremity, and
4.) No history of shoulder surgery to either limb
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with the following criteria will be excluded from participation:

1.) Require a revision shoulder arthroplasty

2.) Recent or previous fractures of the shoulder complex

3.) Adhesive capsulitis

4.) Present with pre-existing conditions associated with upper extremity pain, including ongoing infection, carpal tunnel syndrome, cervical neuropathy or other nerve pathology

5.) Clinically verified polyarthritis, rheumatoid arthritis and/or fibromyalgia

6.) Failed medical clearance to participate in exercise

7.) Are likely to have problems with follow-up (i.e. patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate support network)

8.) Do not read and speak English

9.) The individual is unable or unwilling to follow the designated postoperative rehabilitation protocol

Healthy volunteers above the age of 40, and with a history of upper extremity injury or surgery will be excluded from participating in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a prospective RCT investigating two different peri-operative rehabilitation interventions, in patients scheduled for RSA, therefore patients will first be seen at the private practice of Mr Allan Wang. Patients being offered RSA that meet the inclusion criteria for this study will be invited to participate in the trial. The Patient Information Sheet and a verbal summary of the study and the expected participation will be presented to the patients. Those patients willing to participate will then complete the Patient Consent Form and will be randomised to either the Exercise Group (EM) or Usual Care Group (UM).

Allocation is concealed, and involves contacting the holder of the allocation schedule who is locate at an independent office “off-site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a random number generator on Microsoft Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Power Analysis
A power analysis using G power software18 was performed to calculate the sample size required for this study. Assuming a 5% significance level, a power of 0.8 a sample of 31 patients in each group was required to detect a 10-point difference in ASES scores19, To account for a 5% drop out rate, a total of 66 patients (33 in each group) has been proposed

Statistical Analysis
At baseline, a series of one-way analyses of variance (ANOVA) will be performed to determine if initial differences exist between the two patient groups. To determine the efficacy of a pre-surgery exercise program, a series of one-way analysis of variance (ANOVA) will be performed in conjunction with post-hoc paired t-tests in the results obtained between the pre-intervention and pre-operative time points, and then again at 3-, 6-, and 12 months’ post-surgery. When comparing the effectiveness of the surgery plus the exercise intervention, against the surgery plus usual care, a series of two-factor ANOVAs (group and time) will be taken at pre-surgery, 3-, 6-, and 12 months’ post-surgery.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2016
Actual
1/03/2017
Date of last participant enrolment
Anticipated
1/04/2018
Actual
18/06/2018
Date of last data collection
Anticipated
1/04/2019
Actual
25/06/2019
Sample size
Target
96
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5851 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 13290 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 293683 0
University
Name [1] 293683 0
University of Western Australia
Country [1] 293683 0
Australia
Primary sponsor type
Hospital
Name
St John of God Hospital Subiaco Clinic
Address
302/25 McCourt Street, Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 292516 0
University
Name [1] 292516 0
University of Western Australia
Address [1] 292516 0
School of Sport Science, Exercise and Health (M408)
The University of Western Australia
35 Stirling Highway
Crawley Perth
Western Australia 6009
Country [1] 292516 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295122 0
St John of God Health Care (SJGHC) Human Research Ethics Committee (HREC)
Ethics committee address [1] 295122 0
St John of God Health Care Human Research Ethics Committee
Level 3, St John of God House
177-179 Cambridge Street
Wembley WA 6014
Ethics committee country [1] 295122 0
Australia
Date submitted for ethics approval [1] 295122 0
01/07/2016
Approval date [1] 295122 0
20/07/2016
Ethics approval number [1] 295122 0
Ethics committee name [2] 295628 0
Human Research Ethics Committee (HREC) University of Western Australia
Ethics committee address [2] 295628 0
Human Research Ethics Office (M459) The University of Western Australia 35 Stirling Highway Crawley Perth Western Australia 6009
Ethics committee country [2] 295628 0
Australia
Date submitted for ethics approval [2] 295628 0
20/07/2016
Approval date [2] 295628 0
28/07/2016
Ethics approval number [2] 295628 0
RA/4/1/8533

Summary
Brief summary
Return to sports and physical activity is increasingly being evaluated as a factor in judging orthopaedic surgical outcomes, in particular, joint arthroplasty. Furthermore, patient satisfaction is closely correlated with the resumption of regular activities, and in the case of RSA, it has been shown that those who return to their pre-surgery physical activity and recreational sports after RSA, report greater levels of satisfaction post-surgery. There currently exists a clinically unmet need to evaluate the best and “optimal” course of management before and after reverse shoulder arthroplasty (RSA), and whether this translates to a more successful return to activities of daily living (ADL) and recreational sports. Furthermore, the use of activity monitors in the upper extremity as an alternative method for evaluating patient function post-surgery may allow for a more accurate and objective measurement of the frequency, duration, and intensity of shoulder function in patients after RSA, compared to self-reported questionnaires.

Therefore, this research aims to investigate the benefit of a structured, postoperative exercise program in patients following RSA, compared with control subjects who receive the usual conservative course of management. Furthermore, this study will also investigate the effectiveness of using upper limb activity monitors to objectively capture upper extremity function in patients following RSA. Patients being offered RSA that meet the inclusion criteria for this study will be invited to participate in the trial, and upon acceptance and enrollment, will be randomised into one of the two rehabilitation arms of the study: usual management (UM) group or the exercise management (EM) group. Patients assigned to the exercise group will be required to participate in an 18-week postoperative rehabilitation, whereas those assigned to UM group will follow conservative care. All patients will be assessed clinically using validated subjective and functional assessment measures at specific time-points throughout the postoperative timeline, including body-worn activity monitors. Data obtained from these activity monitors, using previously described algorithms, will be compared between the operated and non-operated upper limbs of patients in both rehabilitation pathways, as well as a matched, healthy control group.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 923 923 0 0
/AnzctrAttachments/370782-Research Plan Study 3_RSA_ethics.docx
Attachments [2] 1960 1960 0 0
/AnzctrAttachments/370782-Research Plan Study 3_RSA_ethics_Amendments_Clean.docx (Protocol)
Attachments [3] 1961 1961 0 0
/AnzctrAttachments/370782-RSA Patient Information Sheet.pdf (Participant information/consent)

Contacts
Principal investigator
Name 66186 0
Dr Jay Ebert
Address 66186 0
School of Sport Science, Exercise and Health
The University of Western Australia
35 Stirling Highway
Crawley Perth
Western Australia 6009
Country 66186 0
Australia
Phone 66186 0
+61 8 9386 9961
Fax 66186 0
Email 66186 0
[email protected]
Contact person for public queries
Name 66187 0
Mr Peter Edwards
Address 66187 0
School of Sport Science, Exercise and Health
The University of Western Australia
35 Stirling Highway
Crawley Perth
Western Australia 6009
Country 66187 0
Australia
Phone 66187 0
+61422370913
Fax 66187 0
Email 66187 0
[email protected]
Contact person for scientific queries
Name 66188 0
Mr Peter Edwards
Address 66188 0
School of Sport Science, Exercise and Health
The University of Western Australia
35 Stirling Highway
Crawley Perth
Western Australia 6009
Country 66188 0
Australia
Phone 66188 0
+61422370913
Fax 66188 0
Email 66188 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No will not be available to comply with anonymous patient data collection as per hospital and institutional ethics


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.