Knee OsteoarthritisPhase 3OmegaNCT00913575
Effect of Pre-surgery Neuromuscular Physiotherapy (PT)
A Phase 3 study testing preoperative neuromuscular training and knee OA School in people with Knee Osteoarthritis, run by University of Zurich at 1 site in Switzerland.
Trial summary
Background: Osteoarthritis (OA) is a common degenerative condition of large weight-bearing joints, such as the hip and knee, as well as small hand joints. Current interventions in patients with OA are limited to symptomatic pain relief and later with total joint replacement (TJR). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- preoperative neuromuscular training and knee OA School
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2009to Jun 2013
- Phase
- Phase 3
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary TKR for primary or secondary OA
- Age 60 years or older
- Community-dwelling
- German language skills in word and writing
Who cannot join
- Age older than 85 years
- Cognitive impairment
- Revision surgery
- Plan to leave Switzerland before or/and after surgery
- History of inflammatory arthritis
- Unable to walk for at least 3 meters with or without walking aid
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital, Centre on Aging and Mobility
Zurich, 8091
About this study
Official title: Effect of Pre-surgery Neuromuscular Physiotherapy (PT) on Functional Outcome After Total Knee Replacement (TKR): A Single-blinded Randomized Controlled Trial.
Background:
Osteoarthritis (OA) is a common degenerative condition of large weight-bearing joints, such as the hip and knee, as well as small hand joints. Current interventions in patients with OA are limited to symptomatic pain relief and later with total joint replacement (TJR). While TJR improves function and pain, it does not fully restore function in most individuals. A key factor of functional outcome is probably conditioning before and after TJR surgery. However, this has not been studied conclusively in patients undergoing TKR surgery.
Read more
Objective:
- Primary endpoint: To study the effect of a pre-surgery neuromuscular PT compared to an attention control program on lower extremity function measured by the Chair stands test (observed function) and the KOOS score (reported function).
- Secondary endpoints will be muscle strength, walking time and mobility.
Hypothesis:
The investigators hypothesize that patients undergoing pre-surgery PT will be significantly quicker in performing the chair stands test and report a significant improvement in the KOOS at 3 months after surgery compared to controls.
Methods:
80 patients from a waiting list for unilateral TKR will be randomized to neuromuscular PT or an attention control group intervention in a single-blinded randomized controlled trial. Assessments will be at baseline, at 3 months after surgery and at 12 months after surgery.
Intervention:
The neuromuscular PT group will receive a minimum of 8 and a maximum of 24 training sessions; all patients, including the control group, will receive 4 sessions of the Knee School.
Significance:
Given the demographic change with an increase in the older segment of the population there will be a rise in the absolute number of TKRs. It is therefore warranted to study pre-surgery neuromuscular PT to help patients get the most out of their joint replacement.
Read the detailed description
Due to the demographic change with a significant increase in the older segment of the population, recent estimates in the United States suggest that the rate of TKR surgery will rise exponentially over the next decade. A similar trend is expected in Switzerland with a marked increase in the absolute number of TKR surgery. Today, patients waiting for TKR surgery in Switzerland are neither routinely participating in an active training program to reduce pain and improve function nor in an educational program to increase coping skills before surgery.
The intervention group will receive neuromuscular training as well as 4 sessions of the Knee OA School. Both will be offered in group sessions separate from the control group.
- The neuromuscular training will take place under the supervision of an experienced physiotherapist, 2 sessions a week of 60 minutes each. The training program, based on neuromuscular and biomechanical principles, according to the possibilities of the patient. The training sessions consists of three parts: warming up (ergometer cycling), a circuit program, and cooling down (walking, stretching, mobility). The circuit program comprises four exercise circles with the key elements of core stability, postural function, functional alignment, lower extremity muscle strength, and functional exercises.
- The Knee School is an educational program and takes place in three group sessions and one individual follow-up session. Patients receive information about: anatomy and physiology of the knee (first group session); proposed physical activity and pain self-management (second group session); and the rehabilitation phase after surgery (third group session).
The control group will receive the Knee School sessions without the neuromuscular PT separate from the intervention group to avoid interaction between the groups.
- Conditions
- Knee Osteoarthritis
- Being tested
- preoperative neuromuscular training, knee OA School
- Keywords
- neuromuscular training, preoperative exercise, physiotherapy, total knee replacement, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative neuromuscular trainingOther
Also called exercise
The neuromuscular training group will receive a minimum of 8 and a maximum of 24 training sessions; as well as 4 sessions of the Knee OA School.
knee OA SchoolBehavioural
Also called knee school
The education group will only receive 4 sessions of the Knee OA School.
| Study group | Role | What they receive |
|---|---|---|
| preoperative neuromuscular training | Experimental | preoperative neuromuscular training Receives: Other: preoperative neuromuscular training |
| education | Placebo comparator | knee school Receives: Behavioral: knee OA School |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb function by the Chair stands (observed measure)
Measured: 6 wks pre-surgery, 1 wk pre-surgery 3 months post-surgery
Secondary outcomes (1)
Lower limb function by the Knee Injury and Osteoarthritis Outcome Score (KOOS) (observed measure)
Measured: 6 wks pre-surgery, 1 wk pre-surgery, 6 wks post-surgery, 3 months post-surgery, 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2012
- Study completionJun 2013
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 Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Olten, Kantonsspital Aarau, Lund University, Maastricht University
- Responsible party
- Principal investigator, Erika Huber, University of Zurich
- Investigators
- Heike A Bischoff-Ferrari, MD, DrPH, Principal investigator, UniversitaetsSpital Zuerich, SwitzerlandEwa M Roos, PT, Prof Dr, Principal investigator, University of Southern Denmark, DenmarkRob A de Bie, PT, Prof Dr, Principal investigator, Maastricht University, NetherlandsChristoph A Schwaller, MD, Dr, Principal investigator, Kantonsspital OltenMarc Zumstein, MD, Dr, Principal investigator, Kantonsspital Aarau, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913575
- Sponsor's protocol ID
- 2009/012
- Acronym
- Omega
- Status last verified
- May 2014
- First submitted
- 12 May 2009
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huber EO, de Bie RA, Roos EM, Bischoff-Ferrari HA. Effect of pre-operative neuromuscular training on functional outcome after total knee replacement: a randomized-controlled trial. BMC Musculoskelet Disord. 2013 May 3;14:157. doi: 10.1186/1471-2474-14-157.
PubMed 23641782
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-surgery Neuromuscular Physiotherapy (PT) on Functional Outcome After Total Knee Replacement (TKR): A Single-blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00913575
- Acronym / sponsor ID
- Omega / 2009/012
- Conditions
- Knee Osteoarthritis
- Keywords
- neuromuscular training, preoperative exercise, physiotherapy, total knee replacement, knee osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Kantonsspital Olten, Kantonsspital Aarau, Lund University, Maastricht University
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Jun 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.
Background:
Osteoarthritis (OA) is a common degenerative condition of large weight-bearing joints, such as the hip and knee, as well as small hand joints. Current interventions in patients with OA are limited to symptomatic pain relief and later with total joint replacement (TJR). While TJR improves function and pain, it does not fully restore function in most individuals. A key factor of functional outcome is probably conditioning before and after TJR surgery. However, this has not been studied conclusively in patients undergoing TKR surgery.
Objective:
- Primary endpoint: To study the effect of a pre-surgery neuromuscular PT compared to an attention control program on lower extremity function measured by the Chair stands test (observed function) and the KOOS score (reported function).
- Secondary endpoints will be muscle strength, walking time and mobility.
Hypothesis:
The investigators hypothesize that patients undergoing pre-surgery PT will be significantly quicker in performing the chair stands test and report a significant improvement in the KOOS at 3 months after surgery compared to controls.
Methods:
80 patients from a waiting list for unilateral TKR will be randomized to neuromuscular PT or an attention control group intervention in a single-blinded randomized controlled trial. Assessments will be at baseline, at 3 months after surgery and at 12 months after surgery.
Intervention:
The neuromuscular PT group will receive a minimum of 8 and a maximum of 24 training sessions; all patients, including the control group, will receive 4 sessions of the Knee School.
Significance:
Given the demographic change with an increase in the older segment of the population there will be a rise in the absolute number of TKRs. It is therefore warranted to study pre-surgery neuromuscular PT to help patients get the most out of their joint replacement.
Detailed description
Due to the demographic change with a significant increase in the older segment of the population, recent estimates in the United States suggest that the rate of TKR surgery will rise exponentially over the next decade. A similar trend is expected in Switzerland with a marked increase in the absolute number of TKR surgery. Today, patients waiting for TKR surgery in Switzerland are neither routinely participating in an active training program to reduce pain and improve function nor in an educational program to increase coping skills before surgery.
The intervention group will receive neuromuscular training as well as 4 sessions of the Knee OA School. Both will be offered in group sessions separate from the control group.
- The neuromuscular training will take place under the supervision of an experienced physiotherapist, 2 sessions a week of 60 minutes each. The training program, based on neuromuscular and biomechanical principles, according to the possibilities of the patient. The training sessions consists of three parts: warming up (ergometer cycling), a circuit program, and cooling down (walking, stretching, mobility). The circuit program comprises four exercise circles with the key elements of core stability, postural function, functional alignment, lower extremity muscle strength, and functional exercises.
- The Knee School is an educational program and takes place in three group sessions and one individual follow-up session. Patients receive information about: anatomy and physiology of the knee (first group session); proposed physical activity and pain self-management (second group session); and the rehabilitation phase after surgery (third group session).
The control group will receive the Knee School sessions without the neuromuscular PT separate from the intervention group to avoid interaction between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative neuromuscular training | Experimental | Other: preoperative neuromuscular trainingpreoperative neuromuscular training |
| education | Placebo comparator | Behavioral: knee OA Schoolknee school |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary TKR for primary or secondary OA
- Age 60 years or older
- Community-dwelling
- German language skills in word and writing
Key exclusion criteria (6 listed)
- Age older than 85 years
- Cognitive impairment
- Revision surgery
- Plan to leave Switzerland before or/and after surgery
- History of inflammatory arthritis
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 trainingAlso: exerciseThe neuromuscular training group will receive a minimum of 8 and a maximum of 24 training sessions; as well as 4 sessions of the Knee OA School. | Other | preoperative neuromuscular training |
| knee OA SchoolAlso: knee schoolThe education group will only receive 4 sessions of the Knee OA School. | Behavioural | education |
Primary outcome
Lower limb function by the Chair stands (observed measure)
Time frame: 6 wks pre-surgery, 1 wk pre-surgery 3 months post-surgery
1 secondary outcome
Lower limb function by the Knee Injury and Osteoarthritis Outcome Score (KOOS) (observed measure)
Time frame: 6 wks pre-surgery, 1 wk pre-surgery, 6 wks post-surgery, 3 months post-surgery, 12 months post-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 22 May 2014.
- Derived from this study: PubMed 23641782Huber EO, de Bie RA, Roos EM, Bischoff-Ferrari HA. Effect of pre-operative neuromuscular training on functional outcome after total knee replacement: a randomized-controlled trial. BMC Musculoskelet Disord. 2013 May 3;14:157. doi: 10.1186/1471-2474-14-157.
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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.
Heike A Bischoff-Ferrari, MD, DrPH principal investigator
UniversitaetsSpital Zuerich, Switzerland
Ewa M Roos, PT, Prof Dr principal investigator
University of Southern Denmark, Denmark
Rob A de Bie, PT, Prof Dr principal investigator
Maastricht University, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing preoperative neuromuscular training and knee OA School in people with Knee Osteoarthritis, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 6 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 22 May 2014. 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lower limb function by the Chair stands (observed measure) (time frame: 6 wks pre-surgery, 1 wk pre-surgery 3 months post-surgery). 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 NCT00913575, 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 22 May 2014.