- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05738200
Nordic Hamstring Exercise After ACL Reconstruction Reconstruction
February 20, 2023 updated by: University of Toledo
Use of Nordic Hamstring Exercise to Improve Hamstrings Function in Patients After ACL Reconstruction
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Toledo, Ohio, United States, 43606
- The University of Toledo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nordic Hamstring Exercise
A 4-week (10 session), progressive, Nordic Hamstring Exercise (NHE) protocol will be used for this study.
|
A 4-week (10 session), progressive, NHE protocol will be used for this study.
Immediately following the completion of study visit 1, patients will be informed about the nature of the NHE protocol.
Those available and willing to participate will be randomized to an intervention group (NHE, control).
Patients randomized to NHE will receive formal instruction about how to correctly perform the exercise, and will be asked to perform several repetitions to familiarize themselves with the exercise and verify proper technique.
At this time, patients will be dismissed from study visit 1, and return visits 2-11 will be scheduled to complete the NHE protocol.
Patients will return for a final study visit (12) to record post-intervention measurements within 7 days of completing the NHE protocol.
A minimum of 48 hours will be used to separate study visits.
To accurately assess patients' ability to perform the NHE, all exercise will be performed on a NordBord Hamstring Testing System.
|
No Intervention: Control
Patients randomized to the control group will be instructed to avoid any changes to their normal routine (e.g., physical activity level, strength training, etc.).
An investigator not involved in data collection will communicate with patients in the control group on a weekly basis to ensure they have not changed their physical activity level and do not have any questions.
Patients randomized to the control group will participate in a minimum of 2 study visits at baseline and 4 weeks.
These individuals will have the option to open enroll in the intervention group at the completion of their original 4-week study period.
Those who choose to enroll in the intervention group at this time will return for 11 additional visits to complete the NHE protocol (visits 3-12) and final assessment (visit 13)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in peak eccentric torque
Time Frame: Baseline, 4 weeks
|
Hamstrings
|
Baseline, 4 weeks
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Change in peak isometric torque
Time Frame: Baseline, 4 weeks
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Hamstrings
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Baseline, 4 weeks
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Change in peak isokinetic torque
Time Frame: Baseline, 4 weeks
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Hamstrings
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Baseline, 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in rate of torque development
Time Frame: Baseline, 4 weeks
|
Hamstrings
|
Baseline, 4 weeks
|
Change in torque coefficient of variation
Time Frame: Baseline, 4 weeks
|
Hamstrings
|
Baseline, 4 weeks
|
Change in central activation ratio
Time Frame: Baseline, 4 weeks
|
Hamstrings
|
Baseline, 4 weeks
|
Change in single leg hop
Time Frame: Baseline, 4 weeks
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Hop for distance
|
Baseline, 4 weeks
|
Change in active motor threshold
Time Frame: Baseline, 4 weeks
|
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
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Baseline, 4 weeks
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Change in cortical silent period
Time Frame: Baseline, 4 weeks
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Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
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Baseline, 4 weeks
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Change in short-interval cortical inhibition
Time Frame: Baseline, 4 weeks
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Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
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Baseline, 4 weeks
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Change in intracortical facilitation
Time Frame: Baseline, 4 weeks
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Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
|
Baseline, 4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in visual analog scale
Time Frame: Baseline, 4 weeks
|
Current knee pain questionnaire (range: 0 [no pain] to 10 [high pain])
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Baseline, 4 weeks
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Change in Tampa Scale of Kinesiophobia 11-item
Time Frame: Baseline, 4 weeks
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Fear of pain-related movement and reinjury questionnaire (range: 11 [low fear] to 44 [high fear])
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Baseline, 4 weeks
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Change in ACL Return to Sport after Injury
Time Frame: Baseline, 4 weeks
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Psychological readiness questionnaire (range: 0 [low readiness] to 100 [high readiness])
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Baseline, 4 weeks
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Change in International Knee Documentation Committee Subjective Knee Evaluation
Time Frame: Baseline, 4 weeks
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Subjective knee function questionnaire (range: 0 [low function] to 100 [high function])
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Baseline, 4 weeks
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Change in Knee Injury and Osteoarthritis Outcome Score
Time Frame: Baseline, 4 weeks
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Subjective knee function questionnaire (range: 0 [low function] to 100 [high function])
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Baseline, 4 weeks
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Veterans RAND 12-Item Health Survey
Time Frame: Baseline, 4 weeks
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Global health questionnaire (range: 0 [low global health] to 100 [high global health])
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Baseline, 4 weeks
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Change in Tegner Activity Scale
Time Frame: Baseline, 4 weeks
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Subjective activity level questionnaire (range: 0 [low activity] to 10 [high activity])
|
Baseline, 4 weeks
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Change in International Physical Activity Questionnaire
Time Frame: Baseline, 4 weeks
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Subjective activity level (higher values = higher activity level)
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Baseline, 4 weeks
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Time spent in moderate-to-vigorous physical activity
Time Frame: 4 weeks
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Objectively monitored physical activity
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4 weeks
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Global Rating of Change
Time Frame: 4 weeks
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Subjective perception of change in knee function following intervention (range: -7 [worse knee function] to 7 [better knee function])
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4 weeks
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Intrinsic Motivation Inventory
Time Frame: 4 weeks (intervention group only)
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Interest/enjoyment and value/usefulness subscale questionnaires (range: 7 [no interest/enjoyment or value/usefulness] to 49 [high interest/enjoyment or value/usefulness])
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4 weeks (intervention group only)
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Average rating of perceived exertion
Time Frame: 4 weeks (intervention group only)
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Subjective perception of effort/difficulty during exercise questionnaire (range: 6 [light effort] to 20 [high effort]), completed during each intervention session
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4 weeks (intervention group only)
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Average visual analog scale
Time Frame: 4 weeks (intervention group only)
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Average pain or discomfort questionnaire (range: 0 [no pain/discomfort] to 10 [high pain/discomfort]), completed during each intervention session
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4 weeks (intervention group only)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Grant Norte, PhD, ATC, The University of Toledo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2018
Primary Completion (Actual)
July 13, 2022
Study Completion (Actual)
July 13, 2022
Study Registration Dates
First Submitted
November 2, 2022
First Submitted That Met QC Criteria
February 20, 2023
First Posted (Estimate)
February 21, 2023
Study Record Updates
Last Update Posted (Estimate)
February 21, 2023
Last Update Submitted That Met QC Criteria
February 20, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202737
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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