Clinical trial NCT05738200: Nordic Hamstring Exercise After ACL Reconstruction Reconstruction
Official title: Use of Nordic Hamstring Exercise to Improve Hamstrings Function in Patients After ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Injury
Muscle Weakness
Neuromuscular Manifestations
Keywords: Eccentric exercise
Hamstrings
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament (ACL) injuries constitute a significant portion of major knee joint injuries sustained by young, active individuals, and significantly increase risk for long-term disability. Yet the recommended solution to restore joint stability following injury--ACL reconstruction (ACLR)--does not prevent post-traumatic knee osteoarthritis (PTOA). Post-traumatic quadriceps (dys)function is a hallmark characteristic following ACLR, reported to accelerate the onset of PTOA after ACL injury, making the recovery of muscle function a primary concern to clinicians. However, hamstrings muscle function is drastically underrepresented relative to the quadriceps in the context of recovery from ACLR, which impedes the ability to develop targeted treatment approaches. Persistent hamstrings weakness is widely reported in patients who undergo ACLR with a hamstring tendon (HT) autograft, which increases ACL strain, and may contribute to higher graft failure rates in this population. To effectively treat muscular impairments, underlying neuromuscular adaptations known to occur in response to ACLR must be targeted. Eccentric exercise is uniquely suited to enhance neuromuscular function. The Nordic hamstring exercise (NHE) is a specific form of eccentric exercise that is clinically relevant and easy to implement, but has not been explored as an intervention for hamstrings neuromuscular dysfunction in patients who undergo ACLR with HT. To establish an evidence-based treatment model, the investigators will use a single-blind, randomized controlled clinical trial to establish the feasibility and efficacy of a 4-week NHE protocol in patients who undergo ACLR with HT. Separate factorial ANOVAs will be used to assess the effects of group (NHE, control) and time (baseline, 4 weeks) on selected outcomes. Effect sizes will be calculated for within- and between-group comparisons. The investigators expect to observe improvements in hamstrings neuromuscular function following the NHE protocol, and that those improvements will be greater than the control group. Additionally, the investigators expect the protocol to be feasible in terms of intervention adherence and patient retention. This study will identify specific barriers to the implementation of NHE in patients who undergo ACLR with HT, and will provide support for the application of an easy to implement clinical intervention able to address a complex neurophysiological problem.


Eligibility criteria: Inclusion Criteria:

* Age 18-35
* History of primary, unilateral ACL reconstruction (ACLR) with hamstrings tendon autograft

Exclusion Criteria:

* Lower extremity orthopedic surgery prior to ACLR
* Post-surgical complication (e.g. infection, delayed healing)
* Multiple ligament knee injury
* Treated articular cartilage lesion
* Known history of knee osteoarthritis
* Concussion within 6 months
* History of neurological disorder
* Currently taking prescription medication that may alter neural excitability (e.g. stimulants, depressants)

Primary outcomes:
measure: Change in peak eccentric torque
timeFrame: Baseline, 4 weeks
measure: Change in peak isometric torque
timeFrame: Baseline, 4 weeks
measure: Change in peak isokinetic torque
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change in rate of torque development
timeFrame: Baseline, 4 weeks
measure: Change in torque coefficient of variation
timeFrame: Baseline, 4 weeks
measure: Change in central activation ratio
timeFrame: Baseline, 4 weeks
measure: Change in single leg hop
timeFrame: Baseline, 4 weeks
measure: Change in active motor threshold
timeFrame: Baseline, 4 weeks
measure: Change in cortical silent period
timeFrame: Baseline, 4 weeks
measure: Change in short-interval cortical inhibition
timeFrame: Baseline, 4 weeks
measure: Change in intracortical facilitation
timeFrame: Baseline, 4 weeks
Other outcomes:
measure: Change in visual analog scale
timeFrame: Baseline, 4 weeks
measure: Change in Tampa Scale of Kinesiophobia 11-item
timeFrame: Baseline, 4 weeks
measure: Change in ACL Return to Sport after Injury
timeFrame: Baseline, 4 weeks
measure: Change in International Knee Documentation Committee Subjective Knee Evaluation
timeFrame: Baseline, 4 weeks
measure: Change in Knee Injury and Osteoarthritis Outcome Score
timeFrame: Baseline, 4 weeks
measure: Veterans RAND 12-Item Health Survey
timeFrame: Baseline, 4 weeks
measure: Change in Tegner Activity Scale
timeFrame: Baseline, 4 weeks
measure: Change in International Physical Activity Questionnaire
timeFrame: Baseline, 4 weeks
measure: Time spent in moderate-to-vigorous physical activity
timeFrame: 4 weeks
measure: Global Rating of Change
timeFrame: 4 weeks
measure: Intrinsic Motivation Inventory
timeFrame: 4 weeks (intervention group only)
measure: Average rating of perceived exertion
timeFrame: 4 weeks (intervention group only)
measure: Average visual analog scale
timeFrame: 4 weeks (intervention group only)
Locations:
city: Toledo
country: United States
facility: The University of Toledo
state: Ohio
Study officials:
affiliation: The University of Toledo
name: Grant Norte, PhD, ATC
role: PRINCIPAL_INVESTIGATOR
References: