Osteoarthritis, KneeQUADX-1NCT02931058
Quadriceps Exercise Before Total Knee Arthroplasty (The QUADX-1 Trial)
A study testing Two knee-extension exercise sessions per week., Four knee-extension exercise sessions per week. and Six knee-extension exercise sessions per week. in people with Osteoarthritis, Knee, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Two knee-extension exercise sessions per week., Four knee-extension exercise sessions per week. and Six knee-extension exercise sessions per week.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinical Research Centre, Amager Hvidovre hospital
Hvidovre, 2650
About this study
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)
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Two knee-extension exercise sessions per week., Four knee-extension exercise sessions per week., Six knee-extension exercise sessions per week.
- Keywords
- Knee-extension exercise, Quadriceps exercise, Knee osteoarthritis, Exercise adherence, Dose-response relationship, Prehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Six knee-extension exercise sessions per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
The measurement will be assessed using a computerized strength chair (Good Strength Chair, Metitur Oy, Jyvaskyla, Finland).
Measured: 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)
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.
Measured: 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)
The test measure the time (seconds) it takes to ascend and descend an 11-step flight of stairs with 16 cm step height.
Measured: 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)
The KOOS is a questionnaire with 42 questions regarding knee function.
Measured: 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)
The OKS is a 12-item questionnaire regarding knee related function and pain in patients with knee OA.
Measured: 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 pain
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).
Measured: 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
Surgical status
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.
Measured: Assessment at 2) after 12 weeks of exercise/just before surgery
Exercise adherence
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.
Measured: Assessment at 2) after 12 weeks of exercise/just before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Skov Husted, Hvidovre University Hospital
- Investigators
- Thomas Bandholm, PhD, Study director, Clinical Research Center, Hvidovre University HospitalRasmus S Husted, MSc., PT., Principal investigator, Clinical Research Center, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931058
- Sponsor's protocol ID
- HvidovreUH - QUADX-1 Trial
- Acronym
- QUADX-1
- Status last verified
- Apr 2022
- First submitted
- 3 Oct 2016
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 35413476Husted 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.
PubMed 33095777Husted 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.
PubMed 29347947
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02931058
- Acronym / sponsor ID
- QUADX-1 / HvidovreUH - QUADX-1 Trial
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee-extension exercise, Quadriceps exercise, Knee osteoarthritis, Exercise adherence, Dose-response relationship, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Active comparator | Other: Two knee-extension exercise sessions per week.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. |
| Group 4 | Active comparator | Other: Four knee-extension exercise sessions per week.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. |
| Group 6 | Active comparator | Other: Six knee-extension exercise sessions per week.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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Patient is resident in one of the three municipalities (København, Hvidovre or Brøndby) involved in the trial
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group 2 |
| 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 | Group 4 |
| 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 | Group 6 |
Primary outcome
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).
8 secondary outcomes
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
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
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
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
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
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
Surgical status
Time frame: Assessment at 2) after 12 weeks of exercise/just before surgery
Exercise adherence
Time frame: Assessment at 2) after 12 weeks of exercise/just before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Derived from this study: PubMed 35413476Husted 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.
- Derived from this study: PubMed 33095777Husted 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.
- Derived from this study: PubMed 29347947Husted 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.
- Physical Medicine \& Rehabilitation Research - Copenhagen (PMR-C)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Bandholm, PhD study director
Clinical Research Center, Hvidovre University Hospital
Rasmus S Husted, MSc., PT. principal investigator
Clinical Research Center, Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two knee-extension exercise sessions per week., Four knee-extension exercise sessions per week. and Six knee-extension exercise sessions per week. in people with Osteoarthritis, Knee, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02931058, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.