Shoulder ArthritisPREPSNCT05965986
Preoperative Rehabilitation and Education Program
A study testing Experimental: PREPS only and Experimental: PREPS and therapy in people with Shoulder Arthritis and Patient Education, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Shoulder problems affect many Canadians yearly. While surgery is one of the best treatments for shoulder problems, patients are unaware about shoulder replacement surgeries, the exercises needed after surgery and how to safely recover from the surgery without having another injury. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Shoulder Arthritis, Patient Education, Prehabilitation
- What is being tested?
- Experimental: PREPS only and Experimental: PREPS and therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18 years old
- Patients who have consented for a total shoulder arthroplasty or reverse shoulder arthroplasty surgery at HULC.
- Date of surgery must be no shorter than 9 weeks, to ensure time for baseline measures
- Speaks and reads in English unless can provide a translator
- Able to provide informed consent.
- Willing to participate in study procedures for at least 1 year post-surgery.
Who cannot join
- Patients who have consented for a hemi-arthroplasty surgery
- Patients who have been consented less than 8 weeks before surgery
- Any contraindications to exercise
Trial locations and contacts
1 site in 1 country.
Canada1 site
Roth | McFarlane Hand and Upper Limb Center
London, Ontario, N6A4L6
Joy MacDermid, PhD
About this study
Official title: Preoperative Patient Education and Rehabilitation Program for a Total Shoulder Arthroplasty Surgery: a Pilot Randomized Control Trial
Shoulder problems affect many Canadians yearly. While surgery is one of the best treatments for shoulder problems, patients are unaware about shoulder replacement surgeries, the exercises needed after surgery and how to safely recover from the surgery without having another injury. Uncertainties about the surgery and recovery process can further cause post-surgery problems such as: pain, anxiety and re-injury. While some healthcare centers offer an in- class program to educate patients before surgery, some patients face issues with distance or transportation, and cannot regularly meet their doctor to address all their concerns. This project aims to create an online educational program that will teach patients through online videos and educational materials before they go into shoulder replacement surgery. By creating online modules, it can increase the accessibility for home use, and prepare patients on topics such as: their concerns about the surgery and proper exercises they can expect after surgery for a safe recovery. The aim is to study three groups of patients before surgery; 1. a group consisting of an online pre-rehabilitation program 6 weeks before surgery, 2. a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist or 3. A group consisting of the current standard of care, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist. Researchers will monitor all groups on their recovery before and after surgery. This will provide another alternative to informing patients before surgery and help them to prepare better for surgery. The online modules will contribute to improving the care in Southern Ontario and eventually be used for future care across Canada.
Read the detailed description
A total shoulder replacement is a common procedure to help those with shoulder osteoarthritis improve their quality of life. There is a lack of quality research on the effectiveness of prehabilitation and education on pain, function, and quality of life in patients undergoing this procedure. Researchers have developed a comprehensive, patient-centered program that combines exercise, preparedness for surgery, motivational interviewing, and pain management principles, in collaboration with patient partners on the wait list for a shoulder replacement, transdisciplinary healthcare team (i.e., surgeons, physiotherapists, occupational therapists, and rehabilitation researchers), and current scientific literature. This patient-centered program has the potential to improve postoperative pain, function, and patient-oriented outcomes, decrease postoperative opioid use and short and long-term healthcare costs. This pilot randomized controlled trial will evaluate feasibility and satisfaction of the program for individuals undergoing a shoulder replacement. Participants (n=90) undergoing a shoulder replacement will be randomized into 1) 6-week online pre-rehab and education program, 2) 6-week online pre-rehab and education program with a therapist or 3) standard of care group. The intervention groups will be delivered virtually with an online program of modules and a written handbook for participants. Participants in the standard of care group will receive usual care. Outcomes will be assessed at baseline and 1 day before surgery, then post-operatively at 6 weeks, 3 months, 6 months and 12 months.
- Being tested
- Experimental: PREPS only, Experimental: PREPS and therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: PREPS onlyOther
Participants will be guided through an education program and exercise program that will cover topics. Participants will have flexibility as to when and how often then need to review material. Participants will be directed to completed on-screen interactive quizzes to re-enforce learning. Participants are encouraged to pose any questions regarding the material they are learning within the education modules to the research team for further clarification.
The intervention group will be asked to participate in the program (6 weeks), but after their surgery, they will not be asked to continue the education or exercise program. However, they will be tracking their activity and adherence to physical therapy through a log for one year post-operative.
Experimental: PREPS and therapyOther
Participants will be guided through an education program and exercise program that will cover topics. Participants will have flexibility as to when and how often then need to review material. Participants will be directed to completed on-screen interactive quizzes to re-enforce learning. Participants are encouraged to pose any questions regarding the material they are learning within the education modules to the research team for further clarification.
The intervention group will be asked to participate in the program (6 weeks), but after their surgery, they will not be asked to continue the education or exercise program. However, they will be tracking their activity and adherence to physical therapy through a log for one year post-operative. In addition, participants will have a therapist call on week 2 and 4 of the program and then one week after surgery to check in and ensure the patient is meeting all milestones and answer any questions.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | No intervention | A group consisting of the current standard of care at HULC, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist. |
| Online only | Experimental | a group consisting of an online pre-rehabilitation program 6 weeks before surgery Receives: Other: Experimental: PREPS only |
| Online and PT | Experimental | a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist Receives: Other: Experimental: PREPS and therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate log
We will proceed with the larger trial if we are able to recruit 90 participants within 6 months, and if 50% of eligible participants consent to participate.
Measured: 6 months
Adherence Rate log
Adherence to the education program will be considered adequate if 80% of all participants in the intervention groups complete the full online program and report it on the log. Exercise programs will be considered adequate if 60% of participants in the intervention groups report exercise at least 3 times per week.
Measured: 6 months
Content Acceptability - visual analog scale
Content acceptability will be assessed using a visual analog scale (VAS), where acceptability will be considered adequate if 60% of participants found the treatment useful and helpful with a score of 7/10.
Measured: 12 months
Study Acceptability - visual analog scale
Similarly, if 60% of participants found the treatment delivery acceptable, and reported being likely to use this treatment again and recommend it to others with a VAS score of 7/10, the format will be considered acceptable.
Measured: 12 months
Treatment Fidelity checklist
if 80% of phone calls were documented accurately and able to meet the criteria of the checklist by the therapist, fidelity will be considered acceptable.
Measured: 12 months
Secondary outcomes (9)
5-level EQ-5D version
General Health Status
Measured: 12 months
Simple Shoulder Test
functional outcome measure
Measured: 12 months
Single Assessment Numeric Evaluation
functional outcome measure
Measured: 12 months
Range of motion
shoulder movement
Measured: 12 months
Surgical Satisfaction Questionnaire
satisfaction with surgery
Measured: 3 months
Decisional Regret
decisional conflict with surgery or the preparation
Measured: 3 months
Adherence to rehabilitation
adherence to a post-surgery rehabilitation program
Measured: 12 months
PASS
Single item to understand people's satisfaction with their current health condition
Measured: 12 months
Shoulder Pain and Disability Index
shoulder pain and function for shoulder conditions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Joy MacDermid, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Joy MacDermid, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965986
- Sponsor's protocol ID
- 120163
- Acronym
- PREPS
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Furtado R, MacDermid JC, Bryant D, Faber KJ. Preoperative rehabilitation and education program for surgery (PREPS): A pilot randomized control trial protocol. Hand Ther. 2025 Jun 20;30(4):200-207. doi: 10.1177/17589983251345393. eCollection 2025 Dec.
PubMed 40547196
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Patient Education and Rehabilitation Program for a Total Shoulder Arthroplasty Surgery: a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05965986
- Acronym / sponsor ID
- PREPS / 120163
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Western University, Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shoulder problems affect many Canadians yearly. While surgery is one of the best treatments for shoulder problems, patients are unaware about shoulder replacement surgeries, the exercises needed after surgery and how to safely recover from the surgery without having another injury. Uncertainties about the surgery and recovery process can further cause post-surgery problems such as: pain, anxiety and re-injury. While some healthcare centers offer an in- class program to educate patients before surgery, some patients face issues with distance or transportation, and cannot regularly meet their doctor to address all their concerns. This project aims to create an online educational program that will teach patients through online videos and educational materials before they go into shoulder replacement surgery. By creating online modules, it can increase the accessibility for home use, and prepare patients on topics such as: their concerns about the surgery and proper exercises they can expect after surgery for a safe recovery. The aim is to study three groups of patients before surgery; 1. a group consisting of an online pre-rehabilitation program 6 weeks before surgery, 2. a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist or 3. A group consisting of the current standard of care, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist. Researchers will monitor all groups on their recovery before and after surgery. This will provide another alternative to informing patients before surgery and help them to prepare better for surgery. The online modules will contribute to improving the care in Southern Ontario and eventually be used for future care across Canada.
Detailed description
A total shoulder replacement is a common procedure to help those with shoulder osteoarthritis improve their quality of life. There is a lack of quality research on the effectiveness of prehabilitation and education on pain, function, and quality of life in patients undergoing this procedure. Researchers have developed a comprehensive, patient-centered program that combines exercise, preparedness for surgery, motivational interviewing, and pain management principles, in collaboration with patient partners on the wait list for a shoulder replacement, transdisciplinary healthcare team (i.e., surgeons, physiotherapists, occupational therapists, and rehabilitation researchers), and current scientific literature. This patient-centered program has the potential to improve postoperative pain, function, and patient-oriented outcomes, decrease postoperative opioid use and short and long-term healthcare costs. This pilot randomized controlled trial will evaluate feasibility and satisfaction of the program for individuals undergoing a shoulder replacement. Participants (n=90) undergoing a shoulder replacement will be randomized into 1) 6-week online pre-rehab and education program, 2) 6-week online pre-rehab and education program with a therapist or 3) standard of care group. The intervention groups will be delivered virtually with an online program of modules and a written handbook for participants. Participants in the standard of care group will receive usual care. Outcomes will be assessed at baseline and 1 day before surgery, then post-operatively at 6 weeks, 3 months, 6 months and 12 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | No intervention | –A group consisting of the current standard of care at HULC, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist. |
| Online only | Experimental | Other: Experimental: PREPS onlya group consisting of an online pre-rehabilitation program 6 weeks before surgery |
| Online and PT | Experimental | Other: Experimental: PREPS and therapya group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over the age of 18 years old
- Patients who have consented for a total shoulder arthroplasty or reverse shoulder arthroplasty surgery at HULC.
- Date of surgery must be no shorter than 9 weeks, to ensure time for baseline measures
- Speaks and reads in English unless can provide a translator
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- Patients who have consented for a hemi-arthroplasty surgery
- Patients who have been consented less than 8 weeks before surgery
- Any contraindications to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: PREPS onlyParticipants will be guided through an education program and exercise program that will cover topics. Participants will have flexibility as to when and how often then need to review material. Participants will be directed to completed on-screen interactive quizzes to re-enforce learning. Participants are encouraged to pose any questions regarding the material they are learning within the education modules to the research team for further clarification. The intervention group will be asked to participate in the program (6 weeks), but after their surgery, they will not be asked to continue the education or exercise program. However, they will be tracking their activity and adherence to physical therapy through a log for one year post-operative. | Other | Online only |
| Experimental: PREPS and therapyParticipants will be guided through an education program and exercise program that will cover topics. Participants will have flexibility as to when and how often then need to review material. Participants will be directed to completed on-screen interactive quizzes to re-enforce learning. Participants are encouraged to pose any questions regarding the material they are learning within the education modules to the research team for further clarification. The intervention group will be asked to participate in the program (6 weeks), but after their surgery, they will not be asked to continue the education or exercise program. However, they will be tracking their activity and adherence to physical therapy through a log for one year post-operative. In addition, participants will have a therapist call on week 2 and 4 of the program and then one week after surgery to check in and ensure the patient is meeting all milestones and answer any questions. | Other | Online and PT |
Primary outcome
Recruitment Rate log
Time frame: 6 months
We will proceed with the larger trial if we are able to recruit 90 participants within 6 months, and if 50% of eligible participants consent to participate.
Adherence Rate log
Time frame: 6 months
Adherence to the education program will be considered adequate if 80% of all participants in the intervention groups complete the full online program and report it on the log. Exercise programs will be considered adequate if 60% of participants in the intervention groups report exercise at least 3 times per week.
Content Acceptability - visual analog scale
Time frame: 12 months
Content acceptability will be assessed using a visual analog scale (VAS), where acceptability will be considered adequate if 60% of participants found the treatment useful and helpful with a score of 7/10.
Study Acceptability - visual analog scale
Time frame: 12 months
Similarly, if 60% of participants found the treatment delivery acceptable, and reported being likely to use this treatment again and recommend it to others with a VAS score of 7/10, the format will be considered acceptable.
Treatment Fidelity checklist
Time frame: 12 months
if 80% of phone calls were documented accurately and able to meet the criteria of the checklist by the therapist, fidelity will be considered acceptable.
9 secondary outcomes
5-level EQ-5D version
Time frame: 12 months
Simple Shoulder Test
Time frame: 12 months
Single Assessment Numeric Evaluation
Time frame: 12 months
Range of motion
Time frame: 12 months
Surgical Satisfaction Questionnaire
Time frame: 3 months
Decisional Regret
Time frame: 3 months
Adherence to rehabilitation
Time frame: 12 months
PASS
Time frame: 12 months
Shoulder Pain and Disability Index
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Derived from this study: PubMed 40547196Furtado R, MacDermid JC, Bryant D, Faber KJ. Preoperative rehabilitation and education program for surgery (PREPS): A pilot randomized control trial protocol. Hand Ther. 2025 Jun 20;30(4):200-207. doi: 10.1177/17589983251345393. eCollection 2025 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy MacDermid, PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: PREPS only and Experimental: PREPS and therapy in people with Shoulder Arthritis and Patient Education, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joy MacDermid, PhD (5196466100 ext. 64636, jmacderm@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate log (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05965986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.