Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02931058
Recruitment Status : Completed
First Posted : October 12, 2016
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Rasmus Skov Husted, Hvidovre University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: Two knee-extension exercise sessions per week. Other: Four knee-extension exercise sessions per week. Other: Six knee-extension exercise sessions per week. Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 2016
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 25, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Group 2

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.

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.
Active Comparator: Group 4

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.

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.
Active Comparator: Group 6

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.

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass [ Time Frame: Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery ]
    The measurement will be assessed using a computerized strength chair (Good Strength Chair, Metitur Oy, Jyvaskyla, Finland).


Secondary Outcome Measures :
  1. Isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass [ Time Frame: 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 ]
    The measurement will be assessed using a computerized strength chair (Good Strength Chair, Metitur Oy, Jyvaskyla, Finland).

  2. 6 min walk test for distance (6MWT) [ Time Frame: 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 ]
    The test measures the maximal distance a participant is able to walk in six minutes between two cones placed 29 meters apart from each other.

  3. Stair climb test (SCT) [ Time Frame: 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 ]
    The test measure the time (seconds) it takes to ascend and descend an 11-step flight of stairs with 16 cm step height.

  4. Knee Osteoarthritis Outcome Score (KOOS) [ Time Frame: 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 ]
    The KOOS is a questionnaire with 42 questions regarding knee function.

  5. Oxford Knee Score (OKS) [ Time Frame: 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 ]
    The OKS is a 12-item questionnaire regarding knee related function and pain in patients with knee OA.

  6. Knee pain [ Time Frame: 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 ]
    Individual knee pain is assessed with the Numeric Rating Scale (NRS). This is an 11-point subjective pain scale ranging from 0-10 (0 indicating no pain).

  7. Surgical status [ Time Frame: Assessment at 2) after 12 weeks of exercise/just before surgery ]
    At the 2nd outcome assessment (after the 12 weeks exercise period) the patients are asked by the outcome assessor "based on your knee symptoms in the last week would you say that you need knee surgery now?" The answer will be categorized into one of three options; 1) 'yes' I believe I need surgery now, 2) I do not know or, 3) 'no' I do not believe I need surgery now.

  8. Exercise adherence [ Time Frame: Assessment at 2) after 12 weeks of exercise/just before surgery ]
    Adherence to the home-based single knee-extension strength exercise will be assessed with elastics exercise bands with build-in BandCizer (sensor) technology.The sensor stores data on date, time, number of sets, repetitions, tonnage (kg x repetitions), and time-under-tension (TUT). In the present trial, a patient is defined as adherent to the exercise intervention if >75% of the prescribed exercise sessions are completed.


Other Outcome Measures:
  1. Adverse events [ Time Frame: 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 ]
    All adverse events occurring while the patient is enrolled in the trial will be recorded regardless of its relation to the exercise intervention, surgery or occurrences not related to the trial.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931058


Locations
Layout table for location information
Denmark
Clinical Research Centre, Amager Hvidovre hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Layout table for investigator information
Study Director: Thomas Bandholm, PhD Clinical Research Center, Hvidovre University Hospital
Principal Investigator: Rasmus S Husted, MSc., PT. Clinical Research Center, Hvidovre University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Rasmus Skov Husted, MSc., PT., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02931058    
Other Study ID Numbers: HvidovreUH - QUADX-1 Trial
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Rasmus Skov Husted, Hvidovre University Hospital:
Knee-extension exercise
Quadriceps exercise
Knee osteoarthritis
 Exercise adherence
Dose-response relationship
Prehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases