PrehabilitationNCT05892133
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
A study testing Maximal strength training in people with Prehabilitation and Knee Osteoarthritis, run by Molde University College at 1 site in Norway.
Trial summary
Knee arthrosis has a high prevalence. Non-surgical treatment, such as exercise, is the first choice of treatment. However, most patients end up having a surgical procedure such as total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Prehabilitation, Knee Osteoarthritis
- What is being tested?
- Maximal strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 5 Sep 2023to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee artrosis, refered to surgery
Who cannot join
- Kognitive disability
- Inflamatory disease in muscles
- varus/ valgus and extension deficit >15 degrees
- Neurological disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Molde University College
Molde, Møre og Romsdal, 6410
Ole Kristian Berg, Dr., +47 71 19 57 71, olbe@himolde.no
About this study
Knee arthrosis has a high prevalence. Non-surgical treatment, such as exercise, is the first choice of treatment. However, most patients end up having a surgical procedure such as total knee arthroplasty. Following surgery with total knee replacement as much as 20% of patients report to not be satisfied with the results. It is noteworthy that this level of dissatisfaction has persisted over the last decades despite formidable progress in surgical methods and technology. Leg strength prior to surgery is associated with faster recovery post operatively, which may influence satisfaction. The investigators aim is to implement a period of strength training prior to surgery to evaluate if training prior to surgery may reduce the level of dissatisfaction post operatively.
- Conditions
- Prehabilitation, Knee Osteoarthritis
- Being tested
- Maximal strength training
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal strength trainingBehavioural
3 sessions/ week. leg press at ~85% of one repetition maximum for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Maximal strength training | Experimental | eight weeks of leg press strength training prior to knee surgery Receives: Behavioral: Maximal strength training |
| Control | No intervention | treatment as usual prior to knee surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Leg press strength
The maximal weight that can be lifted once
Measured: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Group differences in Patient satisfaction
Satisfied with the results of knee surgery: yes/no
Measured: Change from 3 week post-surgery, 12 months post-surgery.
Secondary outcomes (5)
Change in Voluntary activation
Force production of thigh muscle during contraction with superimposed electrical stimulation
Measured: Baseline, 1 week pre-surgery, 3week post-surgery.
Change in Self reported knee function
The Knee Injury and Osteoarthritis Outcome Score - Physical Function - Short Form
Measured: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Change in Walking speed
10 meter walking test
Measured: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Change in Chair rising ability
30 second sit to stand test
Measured: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Change in Balance
unipedal stance test, postural sway
Measured: Baseline, 1 week pre-surgery, 3week 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 posted7 Jun 2023
- Study start5 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
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 PrehabilitationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molde University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berg, Principal investigator, Molde UC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892133
- Sponsor's protocol ID
- 522685
- Status last verified
- Jun 2023
- First submitted
- 3 May 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Izadi M, Toien T, Ohrn FD, Schnell Husby O, Kvitland Schnell Husby V, Bjorgen Winther S, Sherman R, Forsberg Brobakken M, Wang E, Berg OK. Effects of preoperative maximal strength training on muscle strength and function in total knee arthroplasty: A randomized controlled trial. Ann Phys Rehabil Med. 2026 Mar;69(2):102067. doi: 10.1016/j.rehab.2025.102067. Epub 2026 Jan 13.
PubMed 41534474
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05892133
- Acronym / sponsor ID
- 522685
- Conditions
- Prehabilitation, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Molde University CollegeUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Jun 2023 (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.
Knee arthrosis has a high prevalence. Non-surgical treatment, such as exercise, is the first choice of treatment. However, most patients end up having a surgical procedure such as total knee arthroplasty. Following surgery with total knee replacement as much as 20% of patients report to not be satisfied with the results. It is noteworthy that this level of dissatisfaction has persisted over the last decades despite formidable progress in surgical methods and technology. Leg strength prior to surgery is associated with faster recovery post operatively, which may influence satisfaction. The investigators aim is to implement a period of strength training prior to surgery to evaluate if training prior to surgery may reduce the level of dissatisfaction post operatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximal strength training | Experimental | Behavioral: Maximal strength trainingeight weeks of leg press strength training prior to knee surgery |
| Control | No intervention | –treatment as usual prior to knee surgery |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Knee artrosis, refered to surgery
Key exclusion criteria (4 listed)
- Kognitive disability
- Inflamatory disease in muscles
- varus/ valgus and extension deficit >15 degrees
- Neurological disorders
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 training3 sessions/ week. leg press at ~85% of one repetition maximum for 8 weeks | Behavioural | Maximal strength training |
Primary outcome
Change in Leg press strength
Time frame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
The maximal weight that can be lifted once
Group differences in Patient satisfaction
Time frame: Change from 3 week post-surgery, 12 months post-surgery.
Satisfied with the results of knee surgery: yes/no
5 secondary outcomes
Change in Voluntary activation
Time frame: Baseline, 1 week pre-surgery, 3week post-surgery.
Change in Self reported knee function
Time frame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Change in Walking speed
Time frame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Change in Chair rising ability
Time frame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Change in Balance
Time frame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 41534474Izadi M, Toien T, Ohrn FD, Schnell Husby O, Kvitland Schnell Husby V, Bjorgen Winther S, Sherman R, Forsberg Brobakken M, Wang E, Berg OK. Effects of preoperative maximal strength training on muscle strength and function in total knee arthroplasty: A randomized controlled trial. Ann Phys Rehabil Med. 2026 Mar;69(2):102067. doi: 10.1016/j.rehab.2025.102067. Epub 2026 Jan 13.
- Individual participant dataSharing planned: No
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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.
Berg principal investigator
Molde UC
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 Prehabilitation and Knee Osteoarthritis, run by Molde University College 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Dec 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berg (+47 71 19 57 71, olbe@himolde.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Leg press strength (time frame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.). The study lists 2 primary outcomes in all. 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 NCT05892133, 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 15 Dec 2023.