Can Targeted Exercise Improve Knee Strength Following ACLR (RATE)

NCT02939677 | Completed DMC

• 2 other identifiers: SDUSF-2014-5 - (10)SDUSF-2015-20 - (115)
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Rupture of Anterior Cruciate Ligament; Muscle Degeneration; Gait, Unsteady

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in isometric knee extensor strength

  12 weeks (intervention period)

• Change in isometric maximal hamstring to quadriceps strength ratio

  12 weeks (intervention period)

• Change in Self-perceived knee related function

  12 weeks (intervention period)

Other Outcomes (6)

• Gait analysis

  12 weeks (intervention period)

• Counter movement jump

  12 week intervention period

• Change in One-leg jump for distance

  12 week intervention period

Study Arms (2)

Targeted exercise

OTHER

Targeted exercise intervention

Other: Targeted exercise

care as usual

NO INTERVENTION

home based exercises

Interventions

Targeted exercise OTHER

12 weeks of targeted and supervised exercise intervention vs. "care as usual" (home based exercises)

Targeted exercise

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator
• Kolding Sygehus: collaborator

Study Sites (1)

Orthopaedic Research Unit, Institute of Clinical Research, SDU

Odense, Region Syddanmark, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 29373984 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anders Holsgaard-Larsen, ass.proff

  Orthopaedic Research Unit, Institute of Clinical Research, SDU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Cand. Med. Ph.D student

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 20, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)