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

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.

Study Overview

• Status: Completed
• Conditions: Gait, Unsteady; Rupture of Anterior Cruciate Ligament; Muscle Degeneration
• Intervention / Treatment: Other: Targeted exercise

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
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Odense, Region Of Southern Denmark, Denmark, 5000
      • Orthopaedic Research Unit, Institute of Clinical Research, SDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in isometric maximal knee flexor muscle strength	Change, pre- and post intervention using stabilized maximal isometric dynamometry (in Nm)	12 weeks (intervention period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in isometric knee extensor strength	Change, pre- and post intervention using stabilized maximal isometric dynamometry (in Nm)	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)	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)	12 weeks (intervention period)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait analysis	Change, pre- and post intervention (12 weeks) using 3-dimensional Vicon motion analysis	12 weeks (intervention period)
Counter movement jump	Change, pre- and post intervention (12 weeks) using 3-dimensional Vicon motion analysis (force Development)	12 week intervention period
Change in One-leg jump for distance	Change, pre- and post intervention (12 weeks) in jumping distance (in cm). Simple functional test.	12 week intervention period
Change in Quadriceps and hamstring morphologies	Change, pre- and post intervention (12 weeks) concerning volume, peak cross sectional area and length of muscle and tendon, using Magnetic resonance imaging (MRI)	12 week intervention period
Change in Rate of force Development (RFD) in maximal quadriceps and hamstring strenght	Change, pre- and post intervention (12 weeks) using maximal isometric dynamometry (Nm/millisecond)	12 week intervention period
Change in Self-perceived knee related function and symptoms	Change, pre- and post intervention (12 weeks) using Patient reported outcomes (PROM) questionnaires (IKDC, subjective knee evaluation form)	12 week intervention period

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital; Kolding Sygehus
• Investigators: Study Director: Anders Holsgaard-Larsen, ass.proff, Orthopaedic Research Unit, Institute of Clinical Research, SDU

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 20, 2016

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Rupture; Gait Disorders, Neurologic
• Other Study ID Numbers: SDUSF-2014-5 - (10); SDUSF-2015-20 - (115) (Other Identifier: PhD School - Faculty of Health Sciences, SDU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO