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Augmenting Standard Rehabilitation With Blood Flow Restriction for Chronic Achilles Tendinopathy

NCT07699497 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-13

No results posted yet for this study

Summary

Chronic insertional Achilles tendinopathy is a common overuse condition that can be slow to improve with traditional loading-based rehab (e.g., eccentric loading, activity modification, graded return to function). Outcomes are often variable, and persistent symptoms can limit how much load patients can tolerate early in rehab.

This outpatient randomized controlled trial will compare standard-of-care rehabilitation alone versus standard-of-care rehabilitation plus blood flow restriction (BFR) training in adults with chronic insertional Achilles tendinopathy. BFR uses an external cuff to partially restrict blood flow during low-load resistance exercise, aiming to produce strength and hypertrophy adaptations with less mechanical stress than high-load training. Evidence supporting BFR's physiologic effects and safety in musculoskeletal rehab is summarized in clinical research literature.

Participants will be randomized (stratified by baseline activity level and symptom severity) to receive the same rehab program, with the experimental group performing strengthening with BFR using Smart Tools Plus cuffs applied at the proximal thigh and set to 40-80% limb occlusion pressure. The primary outcome will be the VISA-A score (a validated measure of Achilles tendinopathy severity), with secondary outcomes including pain ratings, functional performance tests (e.g., single-leg heel raise endurance, hopping/time-to fatigue), and calf strength via handheld dynamometry.

Conditions

  • Achilles Tendinopathy (AT)

Interventions

BEHAVIORAL

Standard-of-Care Rehabilitation Program for Chronic Insertional Achilles Tendinopathy

Participants complete a standardized outpatient rehabilitation program for chronic insertional Achilles tendinopathy. Standard care includes progressive tendon/calf loading using an eccentric-loading emphasis, education and symptom-guided activity modification, and a graded return-to-function progression. The program is delivered under physical therapy supervision using standard exercise tools, with progression based on participant tolerance and clinical response.

DEVICE

Blood Flow Restriction (BFR) Training Device

Blood flow restriction (BFR) is applied during low-load resistance exercise using Smart Tools Plus cuffs and limb sleeves. The sleeve is used to protect the skin/soft tissue beneath the cuff, and the cuff is placed around the proximal thigh (right and left as applicable). Individual limb occlusion pressure (LOP) is determined immediately prior to exercise; cuff pressure is set to 40%-80% of LOP and maintained during the entire exercise set. Participants are monitored during BFR application for adverse signs/symptoms (e.g., excessive pain, numbness/paresthesia, abnormal discoloration), and BFR is stopped if safety concerns arise.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-06-30
Completion
2026-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07699497 on ClinicalTrials.gov