Recruiting

Blood Flow Restriction

Sponsor:

Denver Health and Hospital Authority

Code:

NCT06496035

Conditions

Tibial Fractures

Lower Extremity Fracture

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Blood Flow Restriction with low load exercise

Therapeutic Exercise

Study Details

Brief summary:

This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.

Conditions

Tibial Fractures

Lower Extremity Fracture

Study ID

NCT06496035

Start date

Nov 1, 2024

Status verified date

Oct, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult with closed tibial shaft fracture
  • Ability to begin physical therapy treatment within 2 weeks post-operatively

Exclusion Criteria:

  • History of osteoporosis or osteopenia
  • Impaired circulation in the limb
  • Active deep vein thrombosis
  • Clotting disorders or other elevated risk of embolism
  • Sickle cell anemia
  • Infection in extremity
  • Renal compromise
  • Severe uncontrolled hypertension (SBP>180)
  • Lymphedema
  • Under age 18
  • Pregnancy
  • Prisoner

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blood flow restriction training

Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device

active comparator: Traditional physical therapy

Patients perform physical therapy exercises guided by a Doctor of Physical Therapy without the use of a blood flow restriction device, as is current standard practice.

Interventions

Blood Flow Restriction with low load exercise

Cuff/tourniquet will be applied to proximal leg at hip crease and inflated to 60-80% of limb occlusion pressure to decrease venous blood flow in the limb while performing exercise.

Therapeutic Exercise

Exercise performed at appropriate load as guided by physical therapist

Primary outcome measure

  • Fracture healing [ Time Frame: 6 weeks, 12 weeks, 6 months ]

Central Contacts and Locations

Central contacts

Megan E Smith, PT, DPT

6513191730megan.smith@dhha.org

Mathew A Haager, PT, DPT

5639407061mat.haager@dhha.org

Locations

Denver Health Medical Center

Recruiting

Denver, Colorado, United States, 80204

Contacts

Megan E Smith, PT, DPT

651-319-1730megan.smith@dhha.org

Mathew A Haager, PT, DPT

5639407061mat.haager@dhha.org

More Information

Sponsor

Denver Health and Hospital Authority

Last update posted

Nov 21, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Denver Health and Hospital Authority on 2025-11-21.