OsteoarthritisNCT01003756
Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement
A study testing Preoperative neuromuscular exercise in people with Osteoarthritis, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This study is conducted in the Community Hospital in Svendborg (OUH Svendborg Sygehus) in collaboration with University of Southern Denmark and Odense University Hospital. The overall purpose of this study is to evaluate the effects of preoperatively delivered neuromuscular exercise on self perceived physical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Preoperative neuromuscular exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to Aug 2011
- 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 scheduled for elective primary, unilateral total hip or knee replacement in Svendborg Community Hospital, Odense University Hospital, Denmark.
- Patients with osteoarthritis
- Age over 18
Who cannot join
- Not being able to read and understand Danish.
- Patients with co-morbidity diseases where a moderate level of physical exercise is contraindicated, e.g. severe heart disease and neurological deficits.
- Patients unable to attend intervention.
- Rheumatoid arthritis (RA). A history of or ongoing use of medication for RA or other inflammatory arthritis such as gold, methotrexate, plaquenil etc.
- Lack of wish to participate or unwillingness to sign an informed consent.
- Specific for hip patients: a history of severe sequelae due to congenital hip-dysplasia requiring specialized postoperative training. A history of femoral neck and trochanteric fracture.
- Patients planned to have bilateral joint replacement within same procedure.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Orthopedics Svendborg Community Hospital
Svendborg, 5700
About this study
This study is conducted in the Community Hospital in Svendborg (OUH Svendborg Sygehus) in collaboration with University of Southern Denmark and Odense University Hospital.
The overall purpose of this study is to evaluate the effects of preoperatively delivered neuromuscular exercise on self perceived physical function, pain and Quality of Life in patients undergoing total hip or knee replacement. Secondary area of interest is physical performance, muscle function, and level of physical activity.
Read more
The project will be conducted in two phases:
- A pilot project focusing on the logistics of the upcoming randomized controlled trial (RCT) and determination of test-retest reliability of specific muscle strength variables for the patients of interest
- A randomized and controlled trial where the intervention is preoperative neuromuscular exercise and the controls receive standard instructions.
- Conditions
- Osteoarthritis
- Being tested
- Preoperative neuromuscular exercise
- Keywords
- Preoperative, Exercise, Joint Replacement, Hip, Knee
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative neuromuscular exerciseOther
A neuromuscular exercise programme delivered 8-10 weeks preoperatively. The programme is developed in Lund, Sweden. A journal of this study is under peer-review
| Study group | Role | What they receive |
|---|---|---|
| Knee Intervention | Experimental | Patients undergoing Total Knee Replacement. Exercise 8-10 weeks preoperatively Receives: Other: Preoperative neuromuscular exercise |
| Knee Control | No intervention | Patients undergoing Total Knee Replacement. Receives standard instructions |
| Hip Intervention | Experimental | Patient undergoing Total Hip Replacement. Exercise 8-10 weeks preoperatively Receives: Other: Preoperative neuromuscular exercise |
| Hip Control | No intervention | Patients undergoing Total Hip Replacement. Receives standard instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function
Further assessments: baseline, preoperative, 6 weeks postoperative and 1-year follow up
Measured: 3 month postoperative (primary endpoint)
Secondary outcomes (5)
Self reported pain. Assessed with KOOS and HOOS subscale on pain.
Measured: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
Self reported quality of life (Qol). Assessed with KOOS and HOOS sub scale quality of life
Measured: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
Self reported quality of life. Assessed with EQ5D questionnaire
Measured: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
Observed physical function. Assessed with performance measures: 20 meter walk, 5 chair stands timed and one leg knee bendings/30 sec
Measured: baseline, one week preop. and 3 month postop.
Muscle strength estimated as average muscle power for muscles of the hip and knee
Measured: baseline, 1 week preop. and 3 month postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Allan Villadsen, University of Southern Denmark
- Investigators
- Ewa Roos, Professor, PT, PhD, Study chair, University of Southern DenmarkAllan Villadsen, MD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003756
- Sponsor's protocol ID
- s-20090099
- Status last verified
- Feb 2012
- First submitted
- 28 Oct 2009
- Last updated
- 7 Feb 2012
- Results posted
- No
Publications
Fernandes L, Roos EM, Overgaard S, Villadsen A, Sogaard R. Supervised neuromuscular exercise prior to hip and knee replacement: 12-month clinical effect and cost-utility analysis alongside a randomised controlled trial. BMC Musculoskelet Disord. 2017 Jan 6;18(1):5. doi: 10.1186/s12891-016-1369-0.
PubMed 28061841Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Immediate efficacy of neuromuscular exercise in patients with severe osteoarthritis of the hip or knee: a secondary analysis from a randomized controlled trial. J Rheumatol. 2014 Jul;41(7):1385-94. doi: 10.3899/jrheum.130642. Epub 2014 Jun 15.
PubMed 24931956Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial. Ann Rheum Dis. 2014 Jun;73(6):1130-7. doi: 10.1136/annrheumdis-2012-203135. Epub 2013 May 9.
PubMed 23661494
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement
- ClinicalTrials.gov ID
- NCT01003756
- Acronym / sponsor ID
- s-20090099
- Conditions
- Osteoarthritis
- Keywords
- Preoperative, Exercise, Joint Replacement, Hip, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Nov 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Oct 2009 (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.
This study is conducted in the Community Hospital in Svendborg (OUH Svendborg Sygehus) in collaboration with University of Southern Denmark and Odense University Hospital.
The overall purpose of this study is to evaluate the effects of preoperatively delivered neuromuscular exercise on self perceived physical function, pain and Quality of Life in patients undergoing total hip or knee replacement. Secondary area of interest is physical performance, muscle function, and level of physical activity.
The project will be conducted in two phases:
- A pilot project focusing on the logistics of the upcoming randomized controlled trial (RCT) and determination of test-retest reliability of specific muscle strength variables for the patients of interest
- A randomized and controlled trial where the intervention is preoperative neuromuscular exercise and the controls receive standard instructions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Knee Intervention | Experimental | Other: Preoperative neuromuscular exercisePatients undergoing Total Knee Replacement. Exercise 8-10 weeks preoperatively |
| Knee Control | No intervention | –Patients undergoing Total Knee Replacement. Receives standard instructions |
| Hip Intervention | Experimental | Other: Preoperative neuromuscular exercisePatient undergoing Total Hip Replacement. Exercise 8-10 weeks preoperatively |
| Hip Control | No intervention | –Patients undergoing Total Hip Replacement. Receives standard instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective primary, unilateral total hip or knee replacement in Svendborg Community Hospital, Odense University Hospital, Denmark.
- Patients with osteoarthritis
- Age over 18
Key exclusion criteria (7 listed)
- Not being able to read and understand Danish.
- Patients with co-morbidity diseases where a moderate level of physical exercise is contraindicated, e.g. severe heart disease and neurological deficits.
- Patients unable to attend intervention.
- Rheumatoid arthritis (RA). A history of or ongoing use of medication for RA or other inflammatory arthritis such as gold, methotrexate, plaquenil etc.
- Lack of wish to participate or unwillingness to sign an informed consent.
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 |
|---|---|---|
| Preoperative neuromuscular exerciseA neuromuscular exercise programme delivered 8-10 weeks preoperatively. The programme is developed in Lund, Sweden. A journal of this study is under peer-review | Other | Hip Intervention, Knee Intervention |
Primary outcome
Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function
Time frame: 3 month postoperative (primary endpoint)
Further assessments: baseline, preoperative, 6 weeks postoperative and 1-year follow up
5 secondary outcomes
Self reported pain. Assessed with KOOS and HOOS subscale on pain.
Time frame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
Self reported quality of life (Qol). Assessed with KOOS and HOOS sub scale quality of life
Time frame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
Self reported quality of life. Assessed with EQ5D questionnaire
Time frame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
Observed physical function. Assessed with performance measures: 20 meter walk, 5 chair stands timed and one leg knee bendings/30 sec
Time frame: baseline, one week preop. and 3 month postop.
Muscle strength estimated as average muscle power for muscles of the hip and knee
Time frame: baseline, 1 week preop. and 3 month postop
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 7 Feb 2012.
- Derived from this study: PubMed 28061841Fernandes L, Roos EM, Overgaard S, Villadsen A, Sogaard R. Supervised neuromuscular exercise prior to hip and knee replacement: 12-month clinical effect and cost-utility analysis alongside a randomised controlled trial. BMC Musculoskelet Disord. 2017 Jan 6;18(1):5. doi: 10.1186/s12891-016-1369-0.
- Derived from this study: PubMed 24931956Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Immediate efficacy of neuromuscular exercise in patients with severe osteoarthritis of the hip or knee: a secondary analysis from a randomized controlled trial. J Rheumatol. 2014 Jul;41(7):1385-94. doi: 10.3899/jrheum.130642. Epub 2014 Jun 15.
- Derived from this study: PubMed 23661494Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial. Ann Rheum Dis. 2014 Jun;73(6):1130-7. doi: 10.1136/annrheumdis-2012-203135. Epub 2013 May 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.
Ewa Roos, Professor, PT, PhD study chair
University of Southern Denmark
Allan Villadsen, MD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative neuromuscular exercise in people with Osteoarthritis, run by University of Southern Denmark at 1 site in Denmark.
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 3 inclusion and 7 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 7 Feb 2012. 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 Denmark. 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?
Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function (time frame: 3 month postoperative (primary endpoint)). 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 NCT01003756, which also lists 3 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 7 Feb 2012.