ClinicalTrials.gov
ClinicalTrials.gov Menu

Can Targeted Exercise Improve Knee Strength Following ACLR (RATE) (RATE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02939677
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
Odense University Hospital
Kolding Sygehus
Information provided by (Responsible Party):
Bo Bregenhof, University of Southern Denmark

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Rupture of Anterior Cruciate Ligament Muscle Degeneration Gait, Unsteady Other: Targeted exercise Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Can Targeted Exercise Improve Knee Strength in Patients With Persisting Hamstring Deficiency Following ACL-reconstruction? - A Randomized Controlled Trial
Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Targeted exercise
Targeted exercise intervention
Other: Targeted exercise
12 weeks of targeted and supervised exercise intervention vs. "care as usual" (home based exercises)

No Intervention: care as usual
home based exercises



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change in isometric knee extensor strength [ Time Frame: 12 weeks (intervention period) ]
    Change, pre- and post intervention using stabilized maximal isometric dynamometry (in Nm)

  2. Change in isometric maximal hamstring to quadriceps strength ratio [ Time Frame: 12 weeks (intervention period) ]
    Change, pre- and post intervention using stabilized maximal isometric dynamometry (in percentage)

  3. Change in Self-perceived knee related function [ Time Frame: 12 weeks (intervention period) ]
    Change, pre- and post intervention, using Patient reported outcomes (PROM) questionnaires (KOOS, Knee injury and Osteoarthritis Outcome Score, all subscales)


Other Outcome Measures:
  1. Gait analysis [ Time Frame: 12 weeks (intervention period) ]
    Change, pre- and post intervention (12 weeks) using 3-dimensional Vicon motion analysis

  2. Counter movement jump [ Time Frame: 12 week intervention period ]
    Change, pre- and post intervention (12 weeks) using 3-dimensional Vicon motion analysis (force Development)

  3. Change in One-leg jump for distance [ Time Frame: 12 week intervention period ]
    Change, pre- and post intervention (12 weeks) in jumping distance (in cm). Simple functional test.

  4. Change in Quadriceps and hamstring morphologies [ Time Frame: 12 week intervention period ]
    Change, pre- and post intervention (12 weeks) concerning volume, peak cross sectional area and length of muscle and tendon, using Magnetic resonance imaging (MRI)

  5. Change in Rate of force Development (RFD) in maximal quadriceps and hamstring strenght [ Time Frame: 12 week intervention period ]
    Change, pre- and post intervention (12 weeks) using maximal isometric dynamometry (Nm/millisecond)

  6. Change in Self-perceived knee related function and symptoms [ Time Frame: 12 week intervention period ]
    Change, pre- and post intervention (12 weeks) using Patient reported outcomes (PROM) questionnaires (IKDC, subjective knee evaluation form)



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.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Other known pathology conditions in hip, knee, or ankle,
  • BMI above 35, and
  • Not understanding written Danish language.

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): NCT02939677


Contacts
Contact: Bo Bregenhof, MD +45 20 63 17 48 Bo.Bregenhof2@rsyd.dk
Contact: Anders Holsgaard-Larsen, Ass. Proff. +45 26 50 39 12 AHLarsen@health.sdu.dk

Locations
Denmark
Orthopaedic Research Unit, Institute of Clinical Research, SDU Recruiting
Odense, Region Of Southern Denmark, Denmark, 5000
Contact: Anders Holsgaard-Larsen, Ass.Prof.    +45 6550 3903    AHLarsen@health.sdu.dk   
Contact: Soren Overgaard, Professor    +45 6541 2286    soeren.overgaard@rsyd.dk   
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Kolding Sygehus
Investigators
Study Director: Anders Holsgaard-Larsen, ass.proff Orthopaedic Research Unit, Institute of Clinical Research, SDU

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bo Bregenhof, M.D. Cand. Med. Ph.D student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02939677     History of Changes
Other Study ID Numbers: SDUSF-2014-5 - (10)
SDUSF-2015-20 - (115) ( Other Identifier: PhD School - Faculty of Health Sciences, SDU )
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Rupture
Anterior Cruciate Ligament Injuries
Gait Disorders, Neurologic
Wounds and Injuries
Knee Injuries
Leg Injuries
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms