None listed
Conditions
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.
Interventions
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.”
Sponsors
Study design
Eligibility
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
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.