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NCT Number: NCT07498166

Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair

The goal of this clinical trial is to determine whether blood flow restriction resistance training (BFR-RT) improves postoperative muscle recovery and functional outcomes following primary surgical repair of acute Achilles tendon rupture (ATR) in adults undergoing standard rehabilitation. The main questions it aims to answer are:

Does patient-specific BFR-RT improve ankle plantarflexion strength recovery compared with sham BFR-RT or standard rehabilitation alone?

Does BFR-RT improve gastrocnemius-soleus muscle morphology and patient-reported functional outcomes following ATR repair?

Researchers will compare (1) BFR-RT combined with standard physical therapy, (2) sham BFR-RT combined with standard physical therapy, and (3) standard physical therapy alone to determine whether BFR-RT enhances muscle recovery, functional outcomes, and return-to-activity timelines following surgical ATR repair.

Participants will:

Be randomized to BFR-RT + standard physical therapy, sham BFR-RT + standard physical therapy, or standard physical therapy alone

Perform supervised rehabilitation exercises using a personalized tourniquet system calibrated to limb occlusion pressure (LOP) depending on group allocation

Undergo isometric ankle plantarflexion strength testing using the Fysiometer platform

Receive ultrasound imaging of the gastrocnemius-soleus complex to assess muscle cross-sectional area

Complete patient-reported outcome measures assessing pain and physical function

Attend follow-up evaluations at 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Department of Orthopaedics

Boston, Massachusetts, 02114, United States

About this study

Achilles tendon rupture (ATR) is a common musculoskeletal injury that frequently results in prolonged functional impairment despite successful surgical repair. Even with modern operative techniques and standardized rehabilitation protocols, many patients demonstrate persistent weakness of the gastrocnemius-soleus complex, deficits in ankle plantarflexion strength, and delayed return to activity. These deficits are thought to arise from a combination of postoperative immobilization, restricted early loading, and muscle atrophy during the early phases of recovery. Conventional postoperative rehabilitation protocols typically emphasize gradual progression of low-load resistance training to protect the healing tendon. While these protocols prioritize tendon safety, they may provide insufficient mechanical and metabolic stimulus to promote optimal muscle hypertrophy and neuromuscular recovery during the early postoperative period.

Blood flow restriction resistance training (BFR-RT) has emerged as a potential strategy to enhance muscular adaptation while using low mechanical loads. By applying controlled external pressure to the proximal limb during exercise, BFR-RT produces localized hypoxia and metabolic stress that can stimulate anabolic signaling pathways associated with muscle hypertrophy and strength gains. Prior studies in orthopedic and sports rehabilitation settings-including anterior cruciate ligament reconstruction and chronic Achilles tendinopathy-have demonstrated that low-load BFR-RT can produce physiologic adaptations comparable to traditional high-load resistance training while minimizing mechanical stress on healing tissues. However, the efficacy and safety of BFR-RT during the early rehabilitation period following primary ATR repair have not been evaluated in a prospective randomized clinical trial.

This study is designed as a prospective, three-arm randomized controlled trial to evaluate whether integrating BFR-RT into postoperative ATR rehabilitation improves early muscle recovery and functional outcomes while maintaining an acceptable safety profile. Participants undergoing primary surgical repair for an acute unilateral mid-portion ATR will be randomized to one of three rehabilitation protocols: BFR-RT combined with standard physical therapy, sham BFR-RT combined with standard physical therapy, or standard physical therapy alone. The BFR intervention will be delivered using a personalized tourniquet system that determines limb occlusion pressure for each participant to standardize vascular restriction and minimize inter-individual variability in occlusion levels.

Participants will undergo standardized postoperative rehabilitation and will be followed longitudinally over a 12-month recovery period. Clinical assessments will be performed at predefined postoperative intervals to evaluate physiologic recovery of the gastrocnemius-soleus complex and patient-centered functional outcomes. Safety monitoring will include systematic documentation of potential adverse events associated with postoperative rehabilitation or vascular restriction techniques.

By evaluating the physiologic and clinical effects of patient-specific BFR-RT following surgical ATR repair, this study aims to generate evidence regarding whether low-load metabolic training can safely accelerate muscle recovery and improve functional rehabilitation outcomes in this population. Findings from this trial may inform future postoperative rehabilitation protocols and help define the role of BFR-RT as an adjunctive strategy in tendon repair recovery pathways.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 75 years
  • Acute unilateral midportion Achilles tendon rupture
  • Primary surgical repair performed within 2 weeks of injury
  • Willingness and ability to comply with the postoperative rehabilitation protocol and follow-up schedule

Exclusion criteria

  • Cognitive impairment or inability to follow study instructions
  • Planned postoperative follow-up at another institution
  • Use of fluoroquinolone antibiotics or systemic corticosteroids within the past 6 months
  • Previous Achilles tendon rupture in either limb
  • Simultaneous bilateral Achilles tendon rupture
  • History of venous thromboembolism (deep venous thrombosis or pulmonary embolism)
  • Diabetes mellitus
  • Reduced lower extremity function due to conditions other than Achilles tendon rupture
  • Uncontrolled hypertension
  • Peripheral vascular disease or ankle-brachial index less than 1.0
  • Chronic kidney disease or heart failure with lower extremity edema
  • Lower extremity dialysis access
  • Lower extremity thrombophlebitis
  • Active cancer or ongoing chemotherapy treatment
  • Prior lymphadenectomy
  • Tumor or malignancy affecting the lower extremities
  • Hemophilia or other major bleeding disorders
  • Factor V Leiden mutation or known thrombophilia
  • Sickle cell anemia
  • Pregnancy
  • Surgery within the previous month

Treatment and study plan

Blood Flow Restriction Resistance Training (BFR-RT)

Device

Blood flow restriction resistance training will be performed using the Delfi Personalized Tourniquet System applied to the affected limb during supervised rehabilitation exercises. The device automatically determines limb occlusion pressure (LOP) and applies 80% of LOP during low-load resistance exercises. This controlled vascular restriction produces metabolic stress intended to stimulate muscle hypertrophy and strength recovery while minimizing mechanical load on the healing Achilles tendon. Sessions are conducted under physiotherapist supervision within the standardized postoperative rehabilitation protocol.

Other names: Delfi Personalized Tourniquet System

Sham Blood Flow Restriction

Device

Participants assigned to the sham group will wear the Delfi tourniquet cuff during rehabilitation sessions; however, cuff pressure will be inflated only to 20 mmHg, a level insufficient to induce vascular occlusion. This condition mimics the experience of the intervention device while avoiding physiologic blood flow restriction, thereby controlling for potential placebo effects associated with device use.

Standard physical therapy

Behavioral

Participants will undergo the standardized postoperative Achilles tendon rehabilitation program used at Massachusetts General Hospital. The protocol includes progressive weight-bearing, range-of-motion exercises, strengthening maneuvers, and return-to-sport progression phases supervised by trained physiotherapists.

Other names: Standard Postoperative Achilles Rehabilitation Protocol

Primary outcomes

  1. Achilles Tendon Total Rupture Score (ATRS)

    Time frame: 12 months postoperatively

    The Achilles Tendon Total Rupture Score (ATRS) is a validated patient-reported outcome instrument used to assess symptoms and physical function following Achilles tendon rupture. The score ranges from 0 to 100, with higher scores indicating better function and fewer symptoms.

Secondary outcomes

  1. Ankle Plantarflexion Isometric Strength (Limb Symmetry Index)

    Time frame: 3 months, 4.5 months, 6 months, and 12 months postoperatively

    Isometric ankle plantarflexion strength will be measured using the Fysiometer platform. Results will be expressed as limb symmetry index (LSI), calculated as the ratio of injured limb strength to contralateral limb strength expressed as a percentage.

  2. Gastrocsoleus Muscle Cross-Sectional Area

    Time frame: 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively

    Cross-sectional area of the gastrocnemius-soleus muscle complex measured using portable ultrasound imaging to quantify muscle morphology and recovery following Achilles tendon repair.

  3. Visual Analog Scale (VAS) Pain Score

    Time frame: 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively

    Pain intensity will be measured using a 10-point Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst possible pain. Higher scores indicate greater pain severity.

  4. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score

    Time frame: 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively

    Pain interference will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference questionnaire. Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population; scores range from approximately 41 to 77, with higher scores indicating greater pain interference with daily activities.

  5. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score

    Time frame: 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively

    Physical function will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire, which evaluates the participant's ability to perform physical activities. Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population; higher scores indicate better physical function.

  6. Foot and Ankle Ability Measure (FAAM)

    Time frame: 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively

    The Foot and Ankle Ability Measure (FAAM) is a validated patient-reported outcome instrument assessing functional limitations related to foot and ankle conditions. Scores range from 0 to 100, with higher scores indicating greater functional ability.

  7. Single-Leg Heel Rise Test

    Time frame: 3 months, 4.5 months, 6 months, and 12 months postoperatively

    Functional calf endurance will be evaluated using the single-leg heel rise test measuring the number of heel raises completed on the affected limb.

  8. Single-Leg Heel Rise Height

    Time frame: 3 months, 4.5 months, 6 months, and 12 months postoperatively

    Heel rise height will be measured during the single-leg heel rise test to assess plantarflexion strength and functional calf performance.

  9. International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    Time frame: 6 months and 12 months postoperatively

    Physical activity levels will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), which evaluates participant activity levels across multiple domains.

  10. EQ-5D-5L Quality of Life Score

    Time frame: 6 months and 12 months postoperatively

    Health-related quality of life will be assessed using the EQ-5D-5L (EuroQol 5-Dimension 5-Level) questionnaire. The EQ-5D-5L index score ranges from 0 to 1, with higher scores indicating better health-related quality of life. A visual analogue scale (VAS) component ranges from 0 to 100, with higher scores indicating better self-rated health.

  11. Ankle Range of Motion

    Time frame: 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively

    Active and passive ankle plantarflexion and dorsiflexion range of motion will be measured bilaterally using a goniometer.

  12. Calf Circumference

    Time frame: 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively

    Bilateral calf circumference measurements will be obtained to assess muscle atrophy and recovery following Achilles tendon repair.

Other outcomes

  1. Return-to-Sport Status and Time

    Time frame: Up to 12 months postoperatively

    Participants will report return-to-sport status and time required to resume pre-injury sport or physical activity.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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