Can Targeted Exercise Improve Knee Strength Following ACLR (RATE)
NCT ID: NCT02939677
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2017-01-31
2020-12-31
Brief Summary
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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
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"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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Targeted exercise
Targeted exercise intervention
Targeted exercise
12 weeks of targeted and supervised exercise intervention vs. "care as usual" (home based exercises)
care as usual
home based exercises
No interventions assigned to this group
Interventions
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Targeted exercise
12 weeks of targeted and supervised exercise intervention vs. "care as usual" (home based exercises)
Eligibility Criteria
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Inclusion Criteria
* 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
* BMI above 35, and
* Not understanding written Danish language.
18 Years
40 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Kolding Sygehus
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Bo Bregenhof
M.D. Cand. Med. Ph.D student
Principal Investigators
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Anders Holsgaard-Larsen, ass.proff
Role: STUDY_DIRECTOR
Orthopaedic Research Unit, Institute of Clinical Research, SDU
Locations
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Orthopaedic Research Unit, Institute of Clinical Research, SDU
Odense, Region Syddanmark, Denmark
Countries
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References
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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.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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SDUSF-2015-20 - (115)
Identifier Type: OTHER
Identifier Source: secondary_id
SDUSF-2014-5 - (10)
Identifier Type: -
Identifier Source: org_study_id