Health TrialsbyHealthPanel

Blood Flow Restriction Training in Patients With Lower Extremity Fractures

ConditionsTibial FracturesLower Extremity Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorDenver Health and Hospital Authority

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult with closed tibial shaft fracture

Ability to begin physical therapy treatment within 2 weeks post-operatively

Disqualifiers

History of osteoporosis or osteopenia

Impaired circulation in the limb

Active deep vein thrombosis

Clotting disorders or other elevated risk of embolism

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood Flow Restriction with low load exercise

    Device

    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

    Other intervention

    Exercise performed at appropriate load as guided by physical therapist

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Blood flow restriction trainingExperimental treatment 1 intervention
Group B: Traditional physical therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fracture healing

Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures

Time frame
6 weeks, 12 weeks, 6 months

Secondary outcomes

1

Muscle strength

Knee extension and ankle plantarflexion strength measured with a dynamometer

Time frame
2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months
2

Muscle girth

Quadriceps and gastrocnemius muscle girth measured 15 cm above and below joint line

Time frame
2, 4, 6, 12 weeks and 6 months
3

Physical function

Subjective measure of function measured by Lower Extremity Functional Scale (LEFS)

Time frame
2, 6,12 weeks and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Denver Health and Hospital Authority

Lead sponsor

Source ClinicalTrials.gov
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