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Completed

NCT Number: NCT05738200

Nordic Hamstring Exercise After ACL Reconstruction 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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Toledo

Toledo, Ohio, 43606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nordic Hamstring Exercise

Other

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 outcomes

  1. Change in peak eccentric torque

    Time frame: Baseline, 4 weeks

    Hamstrings

  2. Change in peak isometric torque

    Time frame: Baseline, 4 weeks

    Hamstrings

  3. Change in peak isokinetic torque

    Time frame: Baseline, 4 weeks

    Hamstrings

Secondary outcomes

  1. Change in rate of torque development

    Time frame: Baseline, 4 weeks

    Hamstrings

  2. Change in torque coefficient of variation

    Time frame: Baseline, 4 weeks

    Hamstrings

  3. Change in central activation ratio

    Time frame: Baseline, 4 weeks

    Hamstrings

  4. Change in single leg hop

    Time frame: Baseline, 4 weeks

    Hop for distance

  5. Change in active motor threshold

    Time frame: Baseline, 4 weeks

    Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus

  6. Change in cortical silent period

    Time frame: Baseline, 4 weeks

    Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus

  7. Change in short-interval cortical inhibition

    Time frame: Baseline, 4 weeks

    Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus

  8. Change in intracortical facilitation

    Time frame: Baseline, 4 weeks

    Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus

Other outcomes

  1. Change in visual analog scale

    Time frame: Baseline, 4 weeks

    Current knee pain questionnaire (range: 0 [no pain] to 10 [high pain])

  2. Change in Tampa Scale of Kinesiophobia 11-item

    Time frame: Baseline, 4 weeks

    Fear of pain-related movement and reinjury questionnaire (range: 11 [low fear] to 44 [high fear])

  3. Change in ACL Return to Sport after Injury

    Time frame: Baseline, 4 weeks

    Psychological readiness questionnaire (range: 0 [low readiness] to 100 [high readiness])

  4. Change in International Knee Documentation Committee Subjective Knee Evaluation

    Time frame: Baseline, 4 weeks

    Subjective knee function questionnaire (range: 0 [low function] to 100 [high function])

  5. Change in Knee Injury and Osteoarthritis Outcome Score

    Time frame: Baseline, 4 weeks

    Subjective knee function questionnaire (range: 0 [low function] to 100 [high function])

  6. Veterans RAND 12-Item Health Survey

    Time frame: Baseline, 4 weeks

    Global health questionnaire (range: 0 [low global health] to 100 [high global health])

  7. Change in Tegner Activity Scale

    Time frame: Baseline, 4 weeks

    Subjective activity level questionnaire (range: 0 [low activity] to 10 [high activity])

  8. Change in International Physical Activity Questionnaire

    Time frame: Baseline, 4 weeks

    Subjective activity level (higher values = higher activity level)

  9. Time spent in moderate-to-vigorous physical activity

    Time frame: 4 weeks

    Objectively monitored physical activity

  10. Global Rating of Change

    Time frame: 4 weeks

    Subjective perception of change in knee function following intervention (range: -7 [worse knee function] to 7 [better knee function])

  11. Intrinsic Motivation Inventory

    Time frame: 4 weeks (intervention group only)

    Interest/enjoyment and value/usefulness subscale questionnaires (range: 7 [no interest/enjoyment or value/usefulness] to 49 [high interest/enjoyment or value/usefulness])

  12. Average rating of perceived exertion

    Time frame: 4 weeks (intervention group only)

    Subjective perception of effort/difficulty during exercise questionnaire (range: 6 [light effort] to 20 [high effort]), completed during each intervention session

  13. Average visual analog scale

    Time frame: 4 weeks (intervention group only)

    Average pain or discomfort questionnaire (range: 0 [no pain/discomfort] to 10 [high pain/discomfort]), completed during each intervention session

Sponsors and collaborators

Lead sponsor

University of Toledo

Other

Registry information

Official study title

Use of Nordic Hamstring Exercise to Improve Hamstrings Function in Patients After ACL Reconstruction

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2023
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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