Clinical trial NCT02931058: Quadriceps Exercise Before Total Knee Arthroplasty (The QUADX-1 Trial)
Official title: Efficacy of Pre-operative Quadriceps Strength Training on Knee-extension Strength Before and Shortly Following Total Knee Arthroplasty: A Randomized Dose-response Trial (The QUADX-1 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee-extension exercise
Quadriceps exercise
Knee osteoarthritis
Exercise adherence
Dose-response relationship
Prehabilitation
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial investigates the efficacy of knee-extension exercise prior to total knee replacement. The participants are randomly allocated to one of three exercise dosages. There is no control group.

Detailed description: Patients with end-stage knee osteoarthritis (OA) have decreased knee-extension strength and suffer from knee pain. Strengthening of the knee-extensor muscle is a key element in conservative treatment for patients with knee OA. However, the most effective exercise dosage for knee-extension strength exercise is unknown.

In this trial the investigators investigate the efficacy of three different dosages of knee-extension strength exercise. Patients eligible for total knee replacement are offered home-based pre-operative knee-extension exercise and are randomly allocated to one of three exercise dosage groups. There is no control group. The knee-extension exercise is performed with an elastic exercise band mounted with sensor (BandCizer) which registers when the patients exercise, how much they exercise and how they exercise.

The intervention time is 12 weeks and the primary time point of interest is after exercise/just before surgery. Secondary time points of interest are shortly after surgery and three months after surgery.

The patients are given detailed exercise instruction at trial entry and hereafter they exercise unsupervised at home for 12 weeks. At week 4 and 8 they receive follow-up instruction.

Both the patients who choose not to have TKA and those who do after the exercise period will be followed with annual outcome assessments as part of a follow-up cohort.

Embedded in the trial is a qualitative study. Focus group interviews will be performed with the participating patients about their experienced enablers and barriers related to adherence to the home-based intervention, once the post-operative outcome assessment has been completed. Likewise, the orthopedic surgeons and physiotherapists allocated to the trial will undergo focus group interviews, once the trial is completed, to explore their experienced enablers and barriers related to administering the home-based intervention.

Protocol amendments 8/2-2017: Additional protocol approved by The Danish National Committee on Biomedical Research Ethics (protocol no. 55528 and 55529). Approved protocol amendments are the following inclusion and exclusion criteria: inclusion criteria age ≥45, and exclusion criteria ASA-score ≥4.

Protocol amendments 30/3-2017: Additional protocol approved by The Danish National Committee on Biomedical Research Ethics (protocol no. 57312). Approved protocol amendments are the following inclusion criteria: knee pain during the last week (NRS) ≥3, and the OKS questionnaire score has been omitted as an inclusion criteria.

Protocol amendments 6/9-2017: At the third outcome assessment (at hospital discharge, 3-8 days after surgery) only the outcomes isometric knee-extensor strength, 6MWT, SCT and current knee pain are assessed. The KOOS and OKS questionnaires as well as knee pain during the last week are omitted at this end-point as they are not validated to assess acute post-operative conditions, and use a too long recall period.

Eligibility criteria: Inclusion Criteria:

* Patient is a possible candidate for a primary TKA due to knee osteoarthritis
* Patient is eligible for home-based quadriceps exercise
* Patient has an age ≥ 50 years
* Patient is a possible candidate for primary unilateral TKA, based on all the below terms:

  * Knee pain \>3 (Numeric Rating Scale) in the last week
  * Kellgren-Lawrence classification grade ≥2
  * Oxford Knee Score \<30
* Patient is resident in one of the three municipalities (København, Hvidovre or Brøndby) involved in the trial
* Patient is able to speak and understand Danish

Exclusion Criteria:

* Exercise is contra-indicated for the patient
* Patient has a neurological disorder
* Patient has a diagnosed systemic disease (ASA score ≥ 3)
* Patients with terminal illness
* Patient has severe bone deformity demanding use of nonstandard implants
* Weekly alcohol consumption above national recommendations (\>7 units women, \>14 units men)

Primary outcomes:
measure: Isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass
timeFrame: Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery
Secondary outcomes:
measure: Isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass
timeFrame: Change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery
measure: 6 min walk test for distance (6MWT)
timeFrame: Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery, and change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery
measure: Stair climb test (SCT)
timeFrame: Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery, and change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery
measure: Knee Osteoarthritis Outcome Score (KOOS)
timeFrame: Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery, and change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery
measure: Oxford Knee Score (OKS)
timeFrame: Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery, and change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery
measure: Knee pain
timeFrame: Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery, and change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery
measure: Surgical status
timeFrame: Assessment at 2) after 12 weeks of exercise/just before surgery
measure: Exercise adherence
timeFrame: Assessment at 2) after 12 weeks of exercise/just before surgery
Other outcomes:
measure: Adverse events
timeFrame: Assessment at 2) after 12 weeks of exercise/just before surgery, 3) at hospital discharge (3-8 days after surgery) and 4) three months after surgery
Locations:
city: Hvidovre
country: Denmark
facility: Clinical Research Centre, Amager Hvidovre hospital
Study officials:
affiliation: Clinical Research Center, Hvidovre University Hospital
name: Thomas Bandholm, PhD
role: STUDY_DIRECTOR
affiliation: Clinical Research Center, Hvidovre University Hospital
name: Rasmus S Husted, MSc., PT.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Husted RS, Troelsen A, Husted H, Gronfeldt BM, Thorborg K, Kallemose T, Rathleff MS, Bandholm T. Knee-extensor strength, symptoms, and need for surgery after two, four, or six exercise sessions/week using a home-based one-exercise program: a randomized dose-response trial of knee-extensor resistance exercise in patients eligible for knee replacement (the QUADX-1 trial). Osteoarthritis Cartilage. 2022 Jul;30(7):973-986. doi: 10.1016/j.joca.2022.04.001. Epub 2022 Apr 9.
citation: Husted RS, Bandholm T, Rathleff MS, Troelsen A, Kirk J. Perceived facilitators and barriers among physical therapists and orthopedic surgeons to pre-operative home-based exercise with one exercise-only in patients eligible for knee replacement: A qualitative interview study nested in the QUADX-1 trial. PLoS One. 2020 Oct 23;15(10):e0241175. doi: 10.1371/journal.pone.0241175. eCollection 2020.
citation: Husted RS, Troelsen A, Thorborg K, Rathleff MS, Husted H, Bandholm T. Efficacy of pre-operative quadriceps strength training on knee-extensor strength before and shortly following total knee arthroplasty: protocol for a randomized, dose-response trial (The QUADX-1 trial). Trials. 2018 Jan 18;19(1):47. doi: 10.1186/s13063-017-2366-9.