Can Targeted Exercise Improve Knee Strength Following ACLR (RATE)

Gait, Unsteady Clinical Trial

— RATE  

Official title:

Can Targeted Exercise Improve Knee Strength in Patients With Persisting Hamstring Deficiency Following ACL-reconstruction? - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939677
• Other study ID #: SDUSF-2014-5 - (10)
• Secondary ID: SDUSF-2015-20 -
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Unsteady
• Muscle Degeneration
• Rupture
• Rupture of Anterior Cruciate Ligament

Intervention

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

Locations

Country	Name	City	State
Denmark	Orthopaedic Research Unit, Institute of Clinical Research, SDU	Odense	Region Of Southern Denmark

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Kolding Sygehus, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gait analysis	Change, pre- and post intervention (12 weeks) using 3-dimensional Vicon motion analysis	12 weeks (intervention period)
Other	Counter movement jump	Change, pre- and post intervention (12 weeks) using 3-dimensional Vicon motion analysis (force Development)	12 week intervention period
Other	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
Other	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
Other	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
Other	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
Primary	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	Change in isometric knee extensor strength	Change, pre- and post intervention using stabilized maximal isometric dynamometry (in Nm)	12 weeks (intervention period)
Secondary	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)
Secondary	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)