OsteoarthritisNCT01877733
Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty
A study testing Maximal strength training in people with Osteoarthritis, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to investigate the effect of maximal strength training (MST) compared to standard rehabilitation in patients operated with total knee arthroplasty. Previous studies report reduced physical function and muscle strength despite successful surgery inserting an artificial implant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Maximal strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Jul 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral osteoarthritis,
- < 75 years
Who cannot join
- disease(s) that compromise testing/training,
- unable to understand written and verbal instructions and information,
- osteoarthritis in the contralateral leg that needs treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effect of maximal strength training (MST) compared to standard rehabilitation in patients operated with total knee arthroplasty. Previous studies report reduced physical function and muscle strength despite successful surgery inserting an artificial implant.
Furthermore, great loss of muscle strength has been found in these patients in the early postoperative phase.
The study is a randomized controlled trial. The investigators hypothesize that MST will increase muscle strength and physical function more than standard rehabilitation.
- Conditions
- Osteoarthritis
- Being tested
- Maximal strength training
- Keywords
- Resistance training
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal strength trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Maximal strenght training | Experimental | Training maximal strength training 3 times a week/1 physiotherapy session for 8 weeks Receives: Other: Maximal strength training |
| Standard rehabilitation | No intervention | 2-3 physiotherapy sessions a week for 8 weeks/telephone contact by project leader once a week/writing training diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength in leg extension and leg press
Measured preoperatively implies measuring the outcome within the last month prior to surgery
Measured: Measured preoperatively, after 7 days, 10 wks and 1 year
Secondary outcomes (4)
6 minute walk test
Measuring the outcome preoperatively implies testing within the last month prior to surgery
Measured: preopertively, 7 days postoperatively and after 1 year
KOOS; Knee injury and osteosarthritis outcome score
Measured: Preoperatively (within 1 month prior to surgery), 7 days postoperatively and 10 wks and 1 year postoperatively
EQ-5D (measure of health outcome)
Measured: Preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively
VAS scale recording pain
Measured: preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionJul 2015
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 OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Vigdis S Husby, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877733
- Sponsor's protocol ID
- 2012/1678
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2013
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Husby VS, Foss OA, Husby OS, Winther SB. Randomized controlled trial of maximal strength training vs. standard rehabilitation following total knee arthroplasty. Eur J Phys Rehabil Med. 2018 Jun;54(3):371-379. doi: 10.23736/S1973-9087.17.04712-8. Epub 2017 Sep 13.
PubMed 28901118Winther SB, Foss OA, Klaksvik J, Husby VS. Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020916392. doi: 10.1177/2309499020916392.
PubMed 32301372
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01877733
- Acronym / sponsor ID
- 2012/1678
- Conditions
- Osteoarthritis
- Keywords
- Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Nord-Trøndelag HF
- Study start
- Jan 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Jun 2013 (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 investigate the effect of maximal strength training (MST) compared to standard rehabilitation in patients operated with total knee arthroplasty. Previous studies report reduced physical function and muscle strength despite successful surgery inserting an artificial implant.
Furthermore, great loss of muscle strength has been found in these patients in the early postoperative phase.
The study is a randomized controlled trial. The investigators hypothesize that MST will increase muscle strength and physical function more than standard rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximal strenght training | Experimental | Other: Maximal strength trainingTraining maximal strength training 3 times a week/1 physiotherapy session for 8 weeks |
| Standard rehabilitation | No intervention | –2-3 physiotherapy sessions a week for 8 weeks/telephone contact by project leader once a week/writing training diary |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral osteoarthritis,
- < 75 years
Key exclusion criteria (3 listed)
- disease(s) that compromise testing/training,
- unable to understand written and verbal instructions and information,
- osteoarthritis in the contralateral leg that needs treatment.
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 |
|---|---|---|
| Maximal strength training | Other | Maximal strenght training |
Primary outcome
Muscle strength in leg extension and leg press
Time frame: Measured preoperatively, after 7 days, 10 wks and 1 year
Measured preoperatively implies measuring the outcome within the last month prior to surgery
4 secondary outcomes
6 minute walk test
Time frame: preopertively, 7 days postoperatively and after 1 year
KOOS; Knee injury and osteosarthritis outcome score
Time frame: Preoperatively (within 1 month prior to surgery), 7 days postoperatively and 10 wks and 1 year postoperatively
EQ-5D (measure of health outcome)
Time frame: Preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively
VAS scale recording pain
Time frame: preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively
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 Apr 2020.
- Results publication: PubMed 28901118Husby VS, Foss OA, Husby OS, Winther SB. Randomized controlled trial of maximal strength training vs. standard rehabilitation following total knee arthroplasty. Eur J Phys Rehabil Med. 2018 Jun;54(3):371-379. doi: 10.23736/S1973-9087.17.04712-8. Epub 2017 Sep 13.
- Results publication: PubMed 32301372Winther SB, Foss OA, Klaksvik J, Husby VS. Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020916392. doi: 10.1177/2309499020916392.
- Individual participant dataSharing planned: Undecided
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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.
Vigdis S Husby, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal strength training in people with Osteoarthritis, run by Norwegian University of Science and Technology at 1 site in Norway.
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 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: finished, as of the sponsor's last update on 22 Apr 2020. 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 Norway. 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?
Muscle strength in leg extension and leg press (time frame: Measured preoperatively, after 7 days, 10 wks and 1 year). 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 NCT01877733, 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 22 Apr 2020.