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NCT03364647 · ClinicalTrials.gov registry record · NA

The Effect of Various Strength Training Protocols in ACL Reconstructed Participants

A NA study, sponsored by Brian W. Noehren.

Completed
Registry status
NA
Development phase
55
Enrollment target

NCT03364647: Completed NA study, sponsored by Brian W. Noehren.

NCT03364647 is a NA study that has completed, run by Brian W. Noehren. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03364647, a NA study, has completed, sponsored by Brian W. Noehren.

COMPLETED
Registry status
NA
Development phase
55 participants
Enrollment target

Study Summary

The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. The investigator also hope to learn how the training affects the properties of muscle in participants who will or have had anterior cruciate ligament (ACL) reconstruction. These results will help define how the training programs are working. There will be no charge to the participant for their physical therapy visits as long as they are part of the study The initial visit and follow up assessment at the end of the training will each take up to 6 hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and questionaires). The physical therapy visits will range from 60-120 minutes depending on the participant's stage of recovery and the activities to engage in. Training sessions will be held 3 days a week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be a total of 4 additional study visits over a 7 month period. The first visit will be used to capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength). The second visit will occur right before surgery to assess changes during prehabilitation (strength and walking mechanics). The third visit will occur 4-5 months after surgery and will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI, strength, gait). The last visit will occur 6-7 months after surgery and will involve an assessment of their thigh muscle strength, walking, and jumping form. The muscle biopsy and magnetic resonance imaging portion of the study will occur in the outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center and the MRI center located on the medical center campus. The muscle biopsy will t

Primary Outcome

Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.

Interventions

  • OTHER Arm A - blood flow restriction training
  • OTHER Arm B - standard of care

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2017-08-21
Est. Completion 2023-10-06
Phase NA
Brian W. Noehren

3 total trials

What the finished NCT03364647 record still lists

NCT03364647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Arm A - blood flow restriction training is the first listed.

NCT03364647 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03364647 about?

NCT03364647 is a clinical study titled "The Effect of Various Strength Training Protocols in ACL Reconstructed Participants". The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. The invest...

What is the current status of trial NCT03364647?

This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2017-08-21. Estimated completion is 2023-10-06.

What interventions are being tested in trial NCT03364647?

The interventions under investigation include: Arm A - blood flow restriction training (OTHER), Arm B - standard of care (OTHER).

Who is sponsoring clinical trial NCT03364647?

This trial is sponsored by Brian W. Noehren, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03364647's enrollment target sits among peer trials

55 1264th of 2000 higher than 733 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03364647, the US trial registry maintained by the National Library of Medicine. NCT03364647 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.