OsteoarthritisPREPNCT00493142
Pre-operative Rehabilitation Exercise Program for Total Knee Arthroplasty
A study testing Exercise in people with Osteoarthritis and Rheumatoid Arthritis, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether a pre-operative home rehabilitation exercise program designed for knee replacements is more effective than pre-operative usual care. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to 25 Nov 2021
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary unilateral total knee arthroplasty
- poor functional status (WOMAC=50 or greater)
- 50 yrs or older
- reside within health region
- understands English
Who cannot join
- unicompartmental total knee arthroplasty
- revision surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Pre-operative Rehabilitation Exercise Program for Patients With Severe Dysfunction Awaiting Total Knee Arthroplasty
The purpose of this study is to determine whether a pre-operative home rehabilitation exercise program designed for knee replacements is more effective than pre-operative usual care.
Read the detailed description
Patients with lower levels of function prior to total knee arthroplasty (TKA) attain lower functional endpoints after surgery. Therapeutic exercise improves function in patients with arthritis of the knee, yet little evidence has examined the impact of pre-operative exercise for TKA.
Single blinded randomized clinical trial comparing a pre-operative home exercise program to pre-operative usual care for patients who are waiting for TKA.Comparison group is usual care within the health region which does not include pre-operative rehabilitation program.
Primary outcome: WOMAC function subscale. Secondary outcomes: 1) quality of life; 2) ambulation; 3) self-efficacy; 4) anxiety; 5) patient satisfaction; 6) cost-effectiveness of this intervention.
Total Enrollment: 230 patients
If the intervention improves function prior to surgery, results will be clinically applicable for patients waiting for surgery
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Being tested
- Exercise, Usual care
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Usual care Receives: Other: Usual care |
| Exercise | Experimental | Exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported function
Self-reported function
Measured: 5 evaluations within 6 months after surgery
Secondary outcomes (5)
Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction
Quality of life
Measured: 5 evaluations within 6 months after surgery
self-efficacy
self-efficacy
Measured: 5 evaluations within 6 months after surgery
ambulation, anxiety and patient satisfaction
ambulation
Measured: 5 evaluations within 6 months after surgery
anxiety
anxiety
Measured: 5 evaluations within 6 months after surgery
patient satisfaction
patient satisfaction
Measured: 5 evaluations within 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJul 2008
- Primary completionJul 2013
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Allyson Jones, PhD, Principal investigator, University of AlbertaLauren Beaupre, PhD, Study director, Capital Health- UAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493142
- Sponsor's protocol ID
- B-060605
- Acronym
- PREP
- Status last verified
- Jul 2022
- First submitted
- 26 Jun 2007
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pre-operative Rehabilitation Exercise Program for Patients With Severe Dysfunction Awaiting Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00493142
- Acronym / sponsor ID
- PREP / B-060605
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 28 Jun 2007 (estimated)
- 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.
The purpose of this study is to determine whether a pre-operative home rehabilitation exercise program designed for knee replacements is more effective than pre-operative usual care.
Detailed description
Patients with lower levels of function prior to total knee arthroplasty (TKA) attain lower functional endpoints after surgery. Therapeutic exercise improves function in patients with arthritis of the knee, yet little evidence has examined the impact of pre-operative exercise for TKA.
Single blinded randomized clinical trial comparing a pre-operative home exercise program to pre-operative usual care for patients who are waiting for TKA.Comparison group is usual care within the health region which does not include pre-operative rehabilitation program.
Primary outcome: WOMAC function subscale. Secondary outcomes: 1) quality of life; 2) ambulation; 3) self-efficacy; 4) anxiety; 5) patient satisfaction; 6) cost-effectiveness of this intervention.
Total Enrollment: 230 patients
If the intervention improves function prior to surgery, results will be clinically applicable for patients waiting for surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careUsual care |
| Exercise | Experimental | Other: ExerciseExercise |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary unilateral total knee arthroplasty
- poor functional status (WOMAC=50 or greater)
- 50 yrs or older
- reside within health region
- understands English
Key exclusion criteria (2 listed)
- unicompartmental total knee arthroplasty
- revision surgery
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 |
|---|---|---|
| Exercise | Other | Exercise |
| Usual care | Other | Usual care |
Primary outcome
Self-reported function
Time frame: 5 evaluations within 6 months after surgery
Self-reported function
5 secondary outcomes
Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction
Time frame: 5 evaluations within 6 months after surgery
self-efficacy
Time frame: 5 evaluations within 6 months after surgery
ambulation, anxiety and patient satisfaction
Time frame: 5 evaluations within 6 months after surgery
anxiety
Time frame: 5 evaluations within 6 months after surgery
patient satisfaction
Time frame: 5 evaluations within 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
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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.
Allyson Jones, PhD principal investigator
University of Alberta
Lauren Beaupre, PhD study director
Capital Health- UAH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Osteoarthritis and Rheumatoid Arthritis, run by University of Alberta 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported function (time frame: 5 evaluations within 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2022.