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
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