Rupture of Anterior Cruciate LigamentRATENCT02939677
Can Targeted Exercise Improve Knee Strength Following ACLR (RATE)
A study testing Targeted exercise in people with Rupture of Anterior Cruciate Ligament and Muscle Degeneration, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Anterior cruciate ligament reconstruction (ACLR) is high volume surgery, carried out in about 2800 patients annually in Denmark per year. ACLR patients (using hamstring auto-graft) have persistent hamstring strength deficiency when evaluated more than 1-2 years after ACL-reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament, Muscle Degeneration, Gait, Unsteady
- What is being tested?
- Targeted exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2017to Dec 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-40 years,
- ACL-reconstructed using hamstring tendon auto-grafts, and a pathological defined between limb asymmetry ratio (operated/non-operated) of more than 10 % for maximal isometric strength of the knee flexors, at 1 year follow-up.
Who cannot join
- Other known pathology conditions in hip, knee, or ankle,
- BMI above 35, and
- Not understanding written Danish language.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Research Unit, Institute of Clinical Research, SDU
Odense, Region Syddanmark, 5000
About this study
Official title: Can Targeted Exercise Improve Knee Strength in Patients With Persisting Hamstring Deficiency Following ACL-reconstruction? - A Randomized Controlled Trial
Anterior cruciate ligament reconstruction (ACLR) is high volume surgery, carried out in about 2800 patients annually in Denmark per year. ACLR patients (using hamstring auto-graft) have persistent hamstring strength deficiency when evaluated more than 1-2 years after ACL-reconstruction. The investigators have designed this randomized controlled trial (RCT) with the main purpose to investigate the effect of a targeted muscle strength exercise intervention on the neuromuscular rehabilitation of ACLR-patients compared with 'care-as- usual'.
The study is designed as a prospective, superiority, parallel-group with balanced randomization (1:1) RCT (Level of evidence: II) with blinded allocation, and outcome assessment according to the CONSORT statement (Consolidated Standards of Reporting Trials). 50 patients with ACL reconstruction and persistent hamstring muscle deficiency, will be recruited at the outpatient clinic 1-year follow-up, and allocated to one of two 12 weeks' interventions, either a) the supervised progressive strength and neuromuscular exercise group (SNG) with supervised training twice weekly. Or b) the control group (CON) receiving patient education based on a home-based exercise regime of low intensity, defined as 'care as usual'. Outcome measures include, maximal isometric knee flexor muscle strength (primary outcome), knee extensor strength, and the Knee injury and Osteoarthritis Outcome Score (KOOS) (secondary outcomes). In addition, the following explorative outcomes will be investigated; hamstring to quadriceps strength ratios, the International Knee Documentation Committee Subjective Knee Form (IKDC), magnetic resonance imaging (MRI) to evaluate tendon regeneration of the hamstrings and finally kinetic/kinematic biomechanical outcomes of knee related functional tasks.
To the investigators knowledge, this is the first RCT to investigate the efficacy of combined progressive resistance training and neuromuscular exercise in the late rehabilitation phase in patients demonstrating persistent limb-to-limb knee muscle asymmetry following ACLR. Reduced hamstring strength represents a potential risk factor for secondary ligament rupture and accelerated progression of osteoarthritis (OA). If deemed effective, the intervention paradigm introduced in this study may help to improve current treatment strategies.
Read the detailed description
Detailed study description available in the published study protocol:
"The effect of targeted exercise on kneemuscle function in patients with persistent hamstring deficiency following ACL reconstruction - study protocol for a randomized controlled trial".
Bo Bregenhof1,3* , Uffe Jørgensen1, Per Aagaard2, Nis Nissen3, Mark W. Creaby4, Jonas Bloch Thorlund2, Carsten Jensen3, Trine Torfing5 and Anders Holsgaard-Larsen1 Published: Trials. 2018; 19: 75. Published online 2018 Jan 26. doi: 10.1186/s13063-018-2448-3
- Being tested
- Targeted exercise
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted exerciseOther
12 weeks of targeted and supervised exercise intervention vs. "care as usual" (home based exercises)
| Study group | Role | What they receive |
|---|---|---|
| Targeted exercise | Other | Targeted exercise intervention Receives: Other: Targeted exercise |
| care as usual | No intervention | home based exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in isometric maximal knee flexor muscle strength
Change, pre- and post intervention using stabilized maximal isometric dynamometry (in Nm)
Measured: 12 weeks (intervention period)
Secondary outcomes (3)
Change in isometric knee extensor strength
Change, pre- and post intervention using stabilized maximal isometric dynamometry (in Nm)
Measured: 12 weeks (intervention period)
Change in isometric maximal hamstring to quadriceps strength ratio
Change, pre- and post intervention using stabilized maximal isometric dynamometry (in percentage)
Measured: 12 weeks (intervention period)
Change in Self-perceived knee related function
Change, pre- and post intervention, using Patient reported outcomes (PROM) questionnaires (KOOS, Knee injury and Osteoarthritis Outcome Score, all subscales)
Measured: 12 weeks (intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rupture of Anterior Cruciate LigamentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Kolding Sygehus
- Responsible party
- Principal investigator, Bo Bregenhof, University of Southern Denmark
- Investigators
- Anders Holsgaard-Larsen, ass.proff, Study director, Orthopaedic Research Unit, Institute of Clinical Research, SDU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939677
- Sponsor's protocol ID
- SDUSF-2014-5 - (10)
- Other IDs
- SDUSF-2015-20 - (115)
- Acronym
- RATE
- Status last verified
- Dec 2020
- First submitted
- 4 Oct 2016
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bregenhof B, Jorgensen U, Aagaard P, Nissen N, Creaby MW, Thorlund JB, Jensen C, Torfing T, Holsgaard-Larsen A. The effect of targeted exercise on knee-muscle function in patients with persistent hamstring deficiency following ACL reconstruction - study protocol for a randomized controlled trial. Trials. 2018 Jan 26;19(1):75. doi: 10.1186/s13063-018-2448-3.
PubMed 29373984
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Targeted Exercise Improve Knee Strength in Patients With Persisting Hamstring Deficiency Following ACL-reconstruction? - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02939677
- Acronym / sponsor ID
- RATE / SDUSF-2014-5 - (10)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Kolding Sygehus
- Study start
- Jan 2017
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 20 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.
Anterior cruciate ligament reconstruction (ACLR) is high volume surgery, carried out in about 2800 patients annually in Denmark per year. ACLR patients (using hamstring auto-graft) have persistent hamstring strength deficiency when evaluated more than 1-2 years after ACL-reconstruction. The investigators have designed this randomized controlled trial (RCT) with the main purpose to investigate the effect of a targeted muscle strength exercise intervention on the neuromuscular rehabilitation of ACLR-patients compared with 'care-as- usual'.
The study is designed as a prospective, superiority, parallel-group with balanced randomization (1:1) RCT (Level of evidence: II) with blinded allocation, and outcome assessment according to the CONSORT statement (Consolidated Standards of Reporting Trials). 50 patients with ACL reconstruction and persistent hamstring muscle deficiency, will be recruited at the outpatient clinic 1-year follow-up, and allocated to one of two 12 weeks' interventions, either a) the supervised progressive strength and neuromuscular exercise group (SNG) with supervised training twice weekly. Or b) the control group (CON) receiving patient education based on a home-based exercise regime of low intensity, defined as 'care as usual'. Outcome measures include, maximal isometric knee flexor muscle strength (primary outcome), knee extensor strength, and the Knee injury and Osteoarthritis Outcome Score (KOOS) (secondary outcomes). In addition, the following explorative outcomes will be investigated; hamstring to quadriceps strength ratios, the International Knee Documentation Committee Subjective Knee Form (IKDC), magnetic resonance imaging (MRI) to evaluate tendon regeneration of the hamstrings and finally kinetic/kinematic biomechanical outcomes of knee related functional tasks.
To the investigators knowledge, this is the first RCT to investigate the efficacy of combined progressive resistance training and neuromuscular exercise in the late rehabilitation phase in patients demonstrating persistent limb-to-limb knee muscle asymmetry following ACLR. Reduced hamstring strength represents a potential risk factor for secondary ligament rupture and accelerated progression of osteoarthritis (OA). If deemed effective, the intervention paradigm introduced in this study may help to improve current treatment strategies.
Detailed description
Detailed study description available in the published study protocol:
"The effect of targeted exercise on kneemuscle function in patients with persistent hamstring deficiency following ACL reconstruction - study protocol for a randomized controlled trial".
Bo Bregenhof1,3* , Uffe Jørgensen1, Per Aagaard2, Nis Nissen3, Mark W. Creaby4, Jonas Bloch Thorlund2, Carsten Jensen3, Trine Torfing5 and Anders Holsgaard-Larsen1 Published: Trials. 2018; 19: 75. Published online 2018 Jan 26. doi: 10.1186/s13063-018-2448-3
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted exercise | Other | Other: Targeted exerciseTargeted exercise intervention |
| care as usual | No intervention | –home based exercises |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18-40 years,
- ACL-reconstructed using hamstring tendon auto-grafts, and a pathological defined between limb asymmetry ratio (operated/non-operated) of more than 10 % for maximal isometric strength of the knee flexors, at 1 year follow-up.
Key exclusion criteria (3 listed)
- Other known pathology conditions in hip, knee, or ankle,
- BMI above 35, and
- Not understanding written Danish language.
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 |
|---|---|---|
| Targeted exercise12 weeks of targeted and supervised exercise intervention vs. "care as usual" (home based exercises) | Other | Targeted exercise |
Primary outcome
Change in isometric maximal knee flexor muscle strength
Time frame: 12 weeks (intervention period)
Change, pre- and post intervention using stabilized maximal isometric dynamometry (in Nm)
3 secondary outcomes
Change in isometric knee extensor strength
Time frame: 12 weeks (intervention period)
Change in isometric maximal hamstring to quadriceps strength ratio
Time frame: 12 weeks (intervention period)
Change in Self-perceived knee related function
Time frame: 12 weeks (intervention period)
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 23 Dec 2020.
- Derived from this study: PubMed 29373984Bregenhof B, Jorgensen U, Aagaard P, Nissen N, Creaby MW, Thorlund JB, Jensen C, Torfing T, Holsgaard-Larsen A. The effect of targeted exercise on knee-muscle function in patients with persistent hamstring deficiency following ACL reconstruction - study protocol for a randomized controlled trial. Trials. 2018 Jan 26;19(1):75. doi: 10.1186/s13063-018-2448-3.
- Individual participant dataSharing planned: No
Related trials for Rupture of Anterior Cruciate Ligament
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Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
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Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
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.
Anders Holsgaard-Larsen, ass.proff study director
Orthopaedic Research Unit, Institute of Clinical Research, SDU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted exercise in people with Rupture of Anterior Cruciate Ligament and Muscle Degeneration, run by University of Southern Denmark 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 2 inclusion and 3 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 23 Dec 2020. 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?
Change in isometric maximal knee flexor muscle strength (time frame: 12 weeks (intervention period)). 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 NCT02939677, which also lists 1 linked publication.
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 23 Dec 2020.