NCT05892133

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
56mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Sep 2023Dec 2030

First Submitted

Initial submission to the registry

May 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

December 15, 2023

Status Verified

June 1, 2023

Enrollment Period

2.3 years

First QC Date

May 3, 2023

Last Update Submit

December 8, 2023

Conditions

PrehabilitationKnee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Change in Leg press strength

    The maximal weight that can be lifted once

    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

    Change from 3 week post-surgery, 12 months post-surgery.

Secondary Outcomes (5)

  • Change in Voluntary activation

    Baseline, 1 week pre-surgery, 3week post-surgery.

  • Change in Self reported knee function

    Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.

  • Change in Walking speed

    Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.

  • Change in Chair rising ability

    Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.

  • Change in Balance

    Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.

Study Arms (2)

Maximal strength training

EXPERIMENTAL

eight weeks of leg press strength training prior to knee surgery

Behavioral: Maximal strength training

Control

NO INTERVENTION

treatment as usual prior to knee surgery

Interventions

Maximal strength trainingBEHAVIORAL

3 sessions/ week. leg press at \~85% of one repetition maximum for 8 weeks

Maximal strength training

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee artrosis, refered to surgery

You may not qualify if:

  • Kognitive disability
  • Inflamatory disease in muscles
  • varus/ valgus and extension deficit \>15 degrees
  • Neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Molde University College

Molde, Møre og Romsdal, 6410, Norway

RECRUITING

Related Publications (1)

  • 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 Jan 13;69(2):102067. doi: 10.1016/j.rehab.2025.102067. Online ahead of print.

    PMID: 41534474DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Berg

    Molde UC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Berg

CONTACT

+47 71 19 57 71olbe@himolde.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

June 7, 2023

Study Start

September 5, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

December 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)