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

NCT ID: NCT03264326

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-26

Study Completion Date

2018-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Achilles Tendinopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participant blinded to group assignment, assessor blinded to group assignment, investigator blinded to analysis.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BFR Group

Blood Flow Restriction Training with Eccentric Exercise Protocol

Group Type EXPERIMENTAL

Blood Flow Restriction Training

Intervention Type OTHER

Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.

Eccentric Exercise

Intervention Type OTHER

Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.

Sham BFR Group

Sham Blood Flow Restriction Training with Eccentric Exercise Protocol

Group Type SHAM_COMPARATOR

Sham Blood Flow Restriction Training

Intervention Type OTHER

Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.

Eccentric Exercise

Intervention Type OTHER

Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood Flow Restriction Training

Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.

Intervention Type OTHER

Sham Blood Flow Restriction Training

Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.

Intervention Type OTHER

Eccentric Exercise

Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Geneva Foundation

OTHER

Sponsor Role collaborator

Telemedicine & Advanced Technology Research Center

OTHER

Sponsor Role collaborator

Womack Army Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert A Whitehurst, DPT

Role: PRINCIPAL_INVESTIGATOR

Womack Army Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Womack Army Medical Center

Fort Bragg, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

161202

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.