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

NCT03264326 | Terminated

• 1 other identifier: 161202
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (2)

• Shear Wave Elastography velocity

  Difference between involved and uninvolved Achilles tendon

  At baseline.

• VISA-A

  Change in subjective self-report of Achilles function

  From baseline to 24 weeks

Secondary Outcomes (8)

• Triple hop test

  At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.

• SL Calf Raise Endurance

  At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.

• SL Jump Height

  At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.

• Thigh Circumference

  At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.

• Calf Circumference

  At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.

Other Outcomes (1)

• Blinding/Group assignment assessment

  At 12 weeks and 24 weeks.

Study Arms (2)

BFR Group

EXPERIMENTAL

Blood Flow Restriction Training with Eccentric Exercise Protocol

Other: Blood Flow Restriction Training; Other: Eccentric Exercise

Sham BFR Group

SHAM COMPARATOR

Sham Blood Flow Restriction Training with Eccentric Exercise Protocol

Other: Sham Blood Flow Restriction Training; Other: Eccentric Exercise

Interventions

Blood Flow Restriction Training OTHER

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

BFR Group

Sham Blood Flow Restriction Training OTHER

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

Sham BFR Group

Eccentric Exercise OTHER

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

BFR Group; Sham BFR Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Womack Army Medical Center: lead
• The Geneva Foundation: collaborator
• Telemedicine & Advanced Technology Research Center: collaborator

Study Sites (1)

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Robert A Whitehurst, DPT

  Womack Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant blinded to group assignment, assessor blinded to group assignment, investigator blinded to analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 29, 2017
• Study Start: October 26, 2017
• Primary Completion: September 5, 2018
• Study Completion: December 30, 2018
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

US (1)