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Nordic Hamstring Exercise After ACL Reconstruction Reconstruction

Primary Purpose

ACL Injury, Muscle Weakness, Neuromuscular Manifestations

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nordic Hamstring Exercise
Sponsored by
University of Toledo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury focused on measuring Eccentric exercise, Hamstrings

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of Toledo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nordic Hamstring Exercise

Control

Arm Description

A 4-week (10 session), progressive, Nordic Hamstring Exercise (NHE) protocol will be used for this study.

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)

Outcomes

Primary Outcome Measures

Change in peak eccentric torque
Hamstrings
Change in peak isometric torque
Hamstrings
Change in peak isokinetic torque
Hamstrings

Secondary Outcome Measures

Change in rate of torque development
Hamstrings
Change in torque coefficient of variation
Hamstrings
Change in central activation ratio
Hamstrings
Change in single leg hop
Hop for distance
Change in active motor threshold
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Change in cortical silent period
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Change in short-interval cortical inhibition
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Change in intracortical facilitation
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus

Full Information

First Posted
November 2, 2022
Last Updated
February 20, 2023
Sponsor
University of Toledo
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1. Study Identification

Unique Protocol Identification Number
NCT05738200
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2018 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, Muscle Weakness, Neuromuscular Manifestations
Keywords
Eccentric exercise, Hamstrings

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nordic Hamstring Exercise
Arm Type
Experimental
Arm Description
A 4-week (10 session), progressive, Nordic Hamstring Exercise (NHE) protocol will be used for this study.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Nordic Hamstring Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in peak eccentric torque
Description
Hamstrings
Time Frame
Baseline, 4 weeks
Title
Change in peak isometric torque
Description
Hamstrings
Time Frame
Baseline, 4 weeks
Title
Change in peak isokinetic torque
Description
Hamstrings
Time Frame
Baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Change in rate of torque development
Description
Hamstrings
Time Frame
Baseline, 4 weeks
Title
Change in torque coefficient of variation
Description
Hamstrings
Time Frame
Baseline, 4 weeks
Title
Change in central activation ratio
Description
Hamstrings
Time Frame
Baseline, 4 weeks
Title
Change in single leg hop
Description
Hop for distance
Time Frame
Baseline, 4 weeks
Title
Change in active motor threshold
Description
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Time Frame
Baseline, 4 weeks
Title
Change in cortical silent period
Description
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Time Frame
Baseline, 4 weeks
Title
Change in short-interval cortical inhibition
Description
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Time Frame
Baseline, 4 weeks
Title
Change in intracortical facilitation
Description
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Time Frame
Baseline, 4 weeks
Other Pre-specified Outcome Measures:
Title
Change in visual analog scale
Description
Current knee pain questionnaire (range: 0 [no pain] to 10 [high pain])
Time Frame
Baseline, 4 weeks
Title
Change in Tampa Scale of Kinesiophobia 11-item
Description
Fear of pain-related movement and reinjury questionnaire (range: 11 [low fear] to 44 [high fear])
Time Frame
Baseline, 4 weeks
Title
Change in ACL Return to Sport after Injury
Description
Psychological readiness questionnaire (range: 0 [low readiness] to 100 [high readiness])
Time Frame
Baseline, 4 weeks
Title
Change in International Knee Documentation Committee Subjective Knee Evaluation
Description
Subjective knee function questionnaire (range: 0 [low function] to 100 [high function])
Time Frame
Baseline, 4 weeks
Title
Change in Knee Injury and Osteoarthritis Outcome Score
Description
Subjective knee function questionnaire (range: 0 [low function] to 100 [high function])
Time Frame
Baseline, 4 weeks
Title
Veterans RAND 12-Item Health Survey
Description
Global health questionnaire (range: 0 [low global health] to 100 [high global health])
Time Frame
Baseline, 4 weeks
Title
Change in Tegner Activity Scale
Description
Subjective activity level questionnaire (range: 0 [low activity] to 10 [high activity])
Time Frame
Baseline, 4 weeks
Title
Change in International Physical Activity Questionnaire
Description
Subjective activity level (higher values = higher activity level)
Time Frame
Baseline, 4 weeks
Title
Time spent in moderate-to-vigorous physical activity
Description
Objectively monitored physical activity
Time Frame
4 weeks
Title
Global Rating of Change
Description
Subjective perception of change in knee function following intervention (range: -7 [worse knee function] to 7 [better knee function])
Time Frame
4 weeks
Title
Intrinsic Motivation Inventory
Description
Interest/enjoyment and value/usefulness subscale questionnaires (range: 7 [no interest/enjoyment or value/usefulness] to 49 [high interest/enjoyment or value/usefulness])
Time Frame
4 weeks (intervention group only)
Title
Average rating of perceived exertion
Description
Subjective perception of effort/difficulty during exercise questionnaire (range: 6 [light effort] to 20 [high effort]), completed during each intervention session
Time Frame
4 weeks (intervention group only)
Title
Average visual analog scale
Description
Average pain or discomfort questionnaire (range: 0 [no pain/discomfort] to 10 [high pain/discomfort]), completed during each intervention session
Time Frame
4 weeks (intervention group only)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant Norte, PhD, ATC
Organizational Affiliation
The University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Nordic Hamstring Exercise After ACL Reconstruction Reconstruction

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