ArthroplastyNCT03483519
Efficacy of Preoperative Muscle Training on Postoperative Orthopaedic Surgery Recovery
A study testing Rehabilitation in people with Arthroplasty and Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to assess the effectiveness of a preoperative muscle training program on hip or knee TJA (Total Joint Arthroplasty). It aims to improve hospital discharge readiness and functional capacity in both the short and long-term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Osteoarthritis
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2016to 14 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and older undergoing unilateral total hip or knee arthroplasty due to osteoarthritis;
- WOMAC functional subscale less than 66.5/100.
Who cannot join
- Patients under 18 years of age;
- Patients undergoing joint revision on the affected side;
- patients under the same day discharge protocol;
- Patients undergoing bilateral arthroplasty;
- Patients suffering from other previously diagnosed lower-limb problems limiting their capacity to accomplish the exercise program;
- Patients having surgery in less than 16 weeks after verbal consent;
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- Patients unable or unwilling to commit to required study follow-ups;
- Patients with no fixed address;
- Patients with a cognitive impairment that may preclude questionnaire completion;
- Pregnant or suspected pregnant women as dual-energy x-ray (DXA) used in this study may be harmful to a fetus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Preoperative Muscle Training on Postoperative Recovery and Function in Patients Undergoing Total Hip or Knee Replacement
The purpose of this study is to assess the effectiveness of a preoperative muscle training program on hip or knee TJA (Total Joint Arthroplasty). It aims to improve hospital discharge readiness and functional capacity in both the short and long-term. One of the key factors affecting recovery after TJA is how well the patient functions before their surgery. Thus, interventions addressing preoperative function are expected to be beneficial.
Read the detailed description
Although total hip or knee joint replacement is beneficial in treating severe hip or knee osteoarthritis, a significant number of patients take longer to recover in the hospital or have a non-optimal quality of life after the surgery. These patients often have difficulties in accomplishing basic essential everyday tasks such as walking and stair climbing, both shortly and long after surgery. It has been previously shown through research that difficulties to do basic tasks before surgery delays recovery and negatively affects long-term function. It has also been shown that these difficulties are associated with reduced strength in hip or knee muscles present before surgery, caused by lack of activity of patients. This study will determine if a hip or knee muscle strengthening exercise program accomplished before surgery can improve hospital recovery, capacity to accomplish basic activities, and quality of life two days, six weeks and six months after joint replacement surgery. If this exercise program is shown to be beneficial, it will be easily used by patients when waiting for their surgery.
- Conditions
- Arthroplasty, Osteoarthritis
- Being tested
- Rehabilitation, Standard of Care
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Patients randomized to the Experimental Group will undergo a 6 Week Exercise Program plus Standard of Care
Standard of CareOther
Patients randomized to the Active Comparator Group will not undergo an exercise program, patients will receive the standard of care used at The Ottawa Hospital for hip and knee surgeries. Standard of care protocol will be explained by each individual surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Patients in the Prehabilitation Group and are randomized to the Experimental Group will undergo a 6 Week Exercise Program plus Standard of Care Receives: Other: Rehabilitation |
| Standard of Care | Active comparator | Patients in the Standard of Care will not receive an additional an exercise program, patients will receive the usual care received by all orthopaedic patients. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOOS or KOOS Questionnaire to assess self-reported pain
The Hip Disability and Osteoarthritis Outcome Score (HOOS) or Knee Injury and Osteoarthritis Outcome Score (KOOS). A standardized set of questions to assess the function of the hip or knee (dependent on which surgery the patient is undergoing). The KOOS/HOOS are comprised of 6 sections: 1) Symptoms (3 items), 2) Stiffness (2 items), 3) Pain (10 items), 4) Function Daily Living (17 items), 5) Function/Sports and Recreation (4 items), 6) Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: 12 months
Secondary outcomes (7)
Timed-Up-and-Go (TUG)
Assesses the time that a patient takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. Time will be measured in seconds.
Measured: 12 months
Timed Stair Test
Assesses the time that a patient takes to ascend and descend a flight of 10 stair, while holding on to the handrail. Time will be measured in seconds.
Measured: 12 months
Length of hospital stay
Length of stay will be calculated from the date of surgery to discharge from an inpatient bed. Length of stay will be measured in days until hospital discharge.
Measured: 1 month
Post-surgical Complications
Post-operative complications and adverse events will be collected using the Ottawa Hospital data warehouse coding data.
Measured: 30 days
Hip or Knee Muscle Strength
For patients undergoing hip surgery, hip abductor strength will be assessed with a hand held dynamometer with the patient in the side-lying position. For patients undergoing knee surgery, quadriceps strength will be measured with a hand held dynamometer with the patient in the supine position and the knee flexed at 60 degrees. A dynamometer is a small machine hand-held by the research assistant that you push on with your leg in order to measure the strength of your muscle (measured in kilograms). The average of three trials will be used. Absolute (affected side only) and relative (difference between non-affected and affected side) strength values will be calculated. Muscle strength will be assessed at baseline, two weeks before surgery, six months and one year after surgery.
Measured: 12 months
Muscle Mass measured with dual-energy x-ray absorptiometry
Body weight and height will be measured. A method called dual-energy x-ray (DXA) will also be used to measure bone density, percent fat and percent lean body mass. The patient will lie on an examination table, wearing a hospital gown, while a low-intensity x-ray will scan the entire body. The measurement takes approximately 20 minutes. The only risk is a minimal x-ray exposure of less than 0.003 mSv, which is less than the natural exposure to sunlight during the course of 1 day. Muscle mass will be assessed at baseline, two weeks before surgery, six months and one year after surgery.
Measured: 12 months
Generic Health Status measured by the Questionnaire EQ-5D-5L
A standardized set of questions to assess generic health status. The EQ-5D-5L questionnaire consists of 2 pages: the EQ-5D descriptive system (5 items) and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The patient is asked to tick the box that is most appropriate to their health within the 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled as 100 ('The best health you can imagine) and 0 (The worst health you can imagine).
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 posted30 Mar 2018
- Study startDec 2016
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
- Investigators
- Paul Beaule, MD, Principal investigator, Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483519
- Sponsor's protocol ID
- 20150684
- Status last verified
- Jun 2021
- First submitted
- 3 Aug 2016
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sled EA, Khoja L, Deluzio KJ, Olney SJ, Culham EG. Effect of a home program of hip abductor exercises on knee joint loading, strength, function, and pain in people with knee osteoarthritis: a clinical trial. Phys Ther. 2010 Jun;90(6):895-904. doi: 10.2522/ptj.20090294. Epub 2010 Apr 8.
PubMed 20378679Pacheco-Brousseau L, Dobransky J, Jane A, Beaule PE, Poitras S. Feasibility of a preoperative strengthening exercise program on postoperative function in patients undergoing hip or knee arthroplasty: a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Jul 30;8(1):162. doi: 10.1186/s40814-022-01126-9.
PubMed 35908037
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Muscle Training on Postoperative Recovery and Function in Patients Undergoing Total Hip or Knee Replacement
- ClinicalTrials.gov ID
- NCT03483519
- Acronym / sponsor ID
- 20150684
- Conditions
- Arthroplasty, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Study start
- Dec 2016 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 30 Mar 2018 (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.
The purpose of this study is to assess the effectiveness of a preoperative muscle training program on hip or knee TJA (Total Joint Arthroplasty). It aims to improve hospital discharge readiness and functional capacity in both the short and long-term. One of the key factors affecting recovery after TJA is how well the patient functions before their surgery. Thus, interventions addressing preoperative function are expected to be beneficial.
Detailed description
Although total hip or knee joint replacement is beneficial in treating severe hip or knee osteoarthritis, a significant number of patients take longer to recover in the hospital or have a non-optimal quality of life after the surgery. These patients often have difficulties in accomplishing basic essential everyday tasks such as walking and stair climbing, both shortly and long after surgery. It has been previously shown through research that difficulties to do basic tasks before surgery delays recovery and negatively affects long-term function. It has also been shown that these difficulties are associated with reduced strength in hip or knee muscles present before surgery, caused by lack of activity of patients. This study will determine if a hip or knee muscle strengthening exercise program accomplished before surgery can improve hospital recovery, capacity to accomplish basic activities, and quality of life two days, six weeks and six months after joint replacement surgery. If this exercise program is shown to be beneficial, it will be easily used by patients when waiting for their 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 |
|---|---|---|
| Prehabilitation | Experimental | Other: RehabilitationPatients in the Prehabilitation Group and are randomized to the Experimental Group will undergo a 6 Week Exercise Program plus Standard of Care |
| Standard of Care | Active comparator | Other: Standard of CarePatients in the Standard of Care will not receive an additional an exercise program, patients will receive the usual care received by all orthopaedic patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 and older undergoing unilateral total hip or knee arthroplasty due to osteoarthritis;
- WOMAC functional subscale less than 66.5/100.
Key exclusion criteria (10 listed)
- Patients under 18 years of age;
- Patients undergoing joint revision on the affected side;
- patients under the same day discharge protocol;
- Patients undergoing bilateral arthroplasty;
- Patients suffering from other previously diagnosed lower-limb problems limiting their capacity to accomplish the exercise program;
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 |
|---|---|---|
| RehabilitationPatients randomized to the Experimental Group will undergo a 6 Week Exercise Program plus Standard of Care | Other | Prehabilitation |
| Standard of CarePatients randomized to the Active Comparator Group will not undergo an exercise program, patients will receive the standard of care used at The Ottawa Hospital for hip and knee surgeries. Standard of care protocol will be explained by each individual surgeon. | Other | Standard of Care |
Primary outcome
HOOS or KOOS Questionnaire to assess self-reported pain
Time frame: 12 months
The Hip Disability and Osteoarthritis Outcome Score (HOOS) or Knee Injury and Osteoarthritis Outcome Score (KOOS). A standardized set of questions to assess the function of the hip or knee (dependent on which surgery the patient is undergoing). The KOOS/HOOS are comprised of 6 sections: 1) Symptoms (3 items), 2) Stiffness (2 items), 3) Pain (10 items), 4) Function Daily Living (17 items), 5) Function/Sports and Recreation (4 items), 6) Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
7 secondary outcomes
Timed-Up-and-Go (TUG)
Time frame: 12 months
Timed Stair Test
Time frame: 12 months
Length of hospital stay
Time frame: 1 month
Post-surgical Complications
Time frame: 30 days
Hip or Knee Muscle Strength
Time frame: 12 months
Muscle Mass measured with dual-energy x-ray absorptiometry
Time frame: 12 months
Generic Health Status measured by the Questionnaire EQ-5D-5L
Time frame: 12 months
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 23 Jun 2021.
- Background: PubMed 20378679Sled EA, Khoja L, Deluzio KJ, Olney SJ, Culham EG. Effect of a home program of hip abductor exercises on knee joint loading, strength, function, and pain in people with knee osteoarthritis: a clinical trial. Phys Ther. 2010 Jun;90(6):895-904. doi: 10.2522/ptj.20090294. Epub 2010 Apr 8.
- Derived from this study: PubMed 35908037Pacheco-Brousseau L, Dobransky J, Jane A, Beaule PE, Poitras S. Feasibility of a preoperative strengthening exercise program on postoperative function in patients undergoing hip or knee arthroplasty: a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Jul 30;8(1):162. doi: 10.1186/s40814-022-01126-9.
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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.
Paul Beaule, MD principal investigator
Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Arthroplasty and Osteoarthritis, run by Ottawa Hospital Research Institute 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 2 inclusion and 10 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 23 Jun 2021. 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?
HOOS or KOOS Questionnaire to assess self-reported pain (time frame: 12 months). 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 NCT03483519, which also lists 2 linked publications.
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 23 Jun 2021.