Efficacy of BFR Training Combined With Eccentric Exercise as Assessed by SWE in Subjects With Chronic AT

May 13, 2019 updated by: Womack Army Medical Center

Efficacy of Blood Flow Restriction Training Combined With Eccentric Exercise as Assessed by Shear Wave Elastography in Subjects With Chronic Achilles Tendinopathy: A Randomized Single Blinded Controlled Trial

The purpose of this randomized controlled trial is to use Shear Wave Elastography (SWE) to assess Achilles tendinopathy and the effectiveness of Blood Flow Restriction (BFR) training in patients with Achilles tendinopathy as measured by Numeric Pain Rating Scale, functional self-report, and objective functional measures. SWE will be utilized to objectively quantify tendon properties and BFR training and eccentric exercise will be utilized to treat Achilles tendinopathy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • North Carolina
      • Fort Bragg, North Carolina, United States, 28310
        • Womack Army Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Achilles pain for > 3 months
  • Unilateral symptoms only
  • DOD beneficiary, between the ages of 18 and 65
  • Clinical diagnosis of Achilles tendinopathy
  • Read and speak English well enough to provide informed consent and follow study instructions.
  • Can attend in-clinic treatments 2-3 x weekly for the next 12 weeks

Exclusion Criteria:

  • Any disease or disease process that would preclude the participant from safely performing any of the exercises or intervention at the discretion of the PI. (Uncontrolled diabetes, cardiac disease, severe COPD, open wounds, current infection, etc.)
  • Any LE surgery on either side in the last 2 years
  • History of Achilles rupture
  • Any vascular disorder (varicose veins, Hx of DVT)
  • Leaving post/station in the following 3 months precluding them being able to come in for f/u visits
  • Self-report of pregnancy (currently or within last 6 months)
  • Other foot/LE disorder that prevents the completion of the eccentric exercises or BFR exercise
  • Unable/unwilling to hop on symptomatic leg
  • Pain < 2/10 of average pain on NPRS
  • VISA A score > 80%
  • Currently going through MEB/worker's comp

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BFR Group
Blood Flow Restriction Training with Eccentric Exercise Protocol
Other: Blood Flow Restriction Training
Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.
Other: Eccentric Exercise
Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.
Sham Comparator: Sham BFR Group
Sham Blood Flow Restriction Training with Eccentric Exercise Protocol
Other: Eccentric Exercise
Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.
Other: Sham Blood Flow Restriction Training
Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shear Wave Elastography velocity
Time Frame: At baseline.
Difference between involved and uninvolved Achilles tendon
At baseline.
VISA-A
Time Frame: From baseline to 24 weeks
Change in subjective self-report of Achilles function
From baseline to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Triple hop test
Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Distance in length of 3 consecutive hops on one foot
At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
SL Calf Raise Endurance
Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Number of single leg calf raises to failure
At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
SL Jump Height
Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Distance in height of single leg jump
At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Thigh Circumference
Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
circumferential measurement of thigh
At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Calf Circumference
Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
circumferential measurement of calf
At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Numerical Pain Rating Scale
Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Pain level on a 0 to 10 scale
At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Global Rating of Change
Time Frame: At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
15 point Likert scale from -7 to +7
At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Shear Wave Elastography velocity
Time Frame: Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks.
Change in shear wave elastography of symptomatic Achilles tendon over time.
Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blinding/Group assignment assessment
Time Frame: At 12 weeks and 24 weeks.
Question asking which group they believe they are in (interventional vs control)
At 12 weeks and 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Womack Army Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Geneva Foundation
Telemedicine & Advanced Technology Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert A Whitehurst, DPT, Womack Army Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 161202

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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