Quadriceps Exercise Before Total Knee Arthroplasty (The QUADX-1 Trial)

NCT02931058 | Completed DMC

• 1 other identifier: HvidovreUH - QUADX-1 Trial
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Knee-extension exercise; Quadriceps exercise; Knee osteoarthritis; Exercise adherence; Dose-response relationship; Prehabilitation

Outcome Measures

Primary Outcomes (1)

• Isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass

  The measurement will be assessed using a computerized strength chair (Good Strength Chair, Metitur Oy, Jyvaskyla, Finland).

  Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery

Secondary Outcomes (8)

• Isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass

  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

• 6 min walk test for distance (6MWT)

  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

• Stair climb test (SCT)

  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

• Knee Osteoarthritis Outcome Score (KOOS)

  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

• Oxford Knee Score (OKS)

  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

Other Outcomes (1)

• Adverse events

  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

Study Arms (3)

Group 2

ACTIVE COMPARATOR

Two knee-extension exercise sessions per week. Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set. The knee-extension resistance training exercise is performed with an elastic exercise band.

Other: Two knee-extension exercise sessions per week.

Group 4

ACTIVE COMPARATOR

Four knee-extension exercise sessions per week. Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set. The knee-extension resistance training exercise is performed with an elastic exercise band.

Other: Four knee-extension exercise sessions per week.

Group 6

ACTIVE COMPARATOR

Six knee-extension exercise sessions per week. Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set. The knee-extension resistance training exercise is performed with an elastic exercise band.

Other: Six knee-extension exercise sessions per week.

Interventions

Two knee-extension exercise sessions per week. OTHER

Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set. The knee-extension resistance training exercise is performed with an elastic exercise band.

Group 2

Four knee-extension exercise sessions per week. OTHER

Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set. The knee-extension resistance training exercise is performed with an elastic exercise band.

Group 4

Six knee-extension exercise sessions per week. OTHER

Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set. The knee-extension resistance training exercise is performed with an elastic exercise band.

Group 6

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Clinical Research Centre, Amager Hvidovre hospital

Hvidovre, 2650, Denmark

Location

Related Publications (3)

• 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.

  PMID: 35413476 DERIVED

• 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.

  PMID: 33095777 DERIVED

• 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.

  PMID: 29347947 DERIVED

Related Links

• Physical Medicine \& Rehabilitation Research - Copenhagen (PMR-C)

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Bandholm, PhD

  Clinical Research Center, Hvidovre University Hospital

  STUDY DIRECTOR

• Rasmus S Husted, MSc., PT.

  Clinical Research Center, Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MSc., PT.

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 12, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 25, 2020
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)