Clinical Trials

A resource for ongoing Personalized Blood Flow Restriction clinical trials. Find out what our partners in the research world are investigating prior to publication.

The purpose of this study is to evaluate the ability of blood flow restriction therapy to improve strength of shoulder muscles during the side-lying external rotation (ER) exercise versus a control group who only performs the side-lying ER exercise.

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Open label randomized controlled trial comparing evidenced based physical/occupational therapy vs. physical/occupational therapy including blood flow restriction tourniquet in the treatment of lateral epicondylitis (tennis elbow).

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The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. The investigator also hope to learn how the training affects the properties of muscle in participants who will or have had anterior cruciate ligament (ACL) reconstruction. These results will help define how the training programs are working.

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The investigators will compare differences in quadriceps strength, leg girth, and functional outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by the standard protocol progression for the remainder of the treatment program. The other group will receive standard post-operative rehabilitation without BFR for the duration of treatment program.

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The goal of this study is to assess whether 6 weeks of cyclical blood flow restriction aerobic exercise leads to improvements in systemic and cerebral vascular function in young (< 40 years) and older (>55 years) healthy subjects. This study will provide essential data to support the investigation of cyclical blood flow restriction exercise in “at-risk” patient populations, such as patients undergoing stroke and cardiac rehabilitation.

The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be conducted in a patient population of individuals recovering from a traumatic diaphyseal fracture of the femur. Although the intervention can be used for any patient with muscle weakness following trauma, the persistent thigh weakness that follows a femur fracture provides a perfect model for evaluating the effectiveness of the REPAIR protocol.

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The purpose of this study is to assess the potential increased mobilization of hematopoietic stem cells after an acute bout of thigh dominant BFR exercises compared to a work matched non-BFR control. Significant increases may assist in augmenting orthobiologics and/or support regenerative medicine approaches in rehabilitation.

Blood flow restricted (BFR) exercise has been shown to improve skeletal muscle adaptations to resistance exercise.  BFR uses blood pressure cuffs (i.e., tourniquets) to reduce skeletal muscle blood flow during resistance exercise.  One benefit of BFR is that skeletal muscle adaptations to resistance exercise training including muscle hypertrophy and increases in strength can be achieved at lower-loads (e.g., 30% 1RM), that are often comparable to more traditional resistance training loads (70-85% 1RM).  However, the impact that low-load BFR resistance exercise has on muscle quality and bioenergetics is unknown.  We propose to examine the impact of 6 weeks of low-load single-leg resistance exercise training with or without personalized blood flow restriction on measures of muscle mass, strength, quality, and mitochondrial bioenergetics.  We will recruit and study up to 30, previously sedentary, healthy, college-aged adults (18-40 years).  We will measure muscle mass using Dual Energy X-Ray Absorptiometry and muscle strength and endurance using isokinetic testing.  We will normalize knee extensor strength to lower limb lean mass to quantify muscle quality.  We will also use near infrared spectroscopy (NIRS) to measure mitochondrial oxidative capacity in the vastus lateralis.  Finally, we will measure markers of systemic inflammation and markers of muscle damage using commercially available ELISA assays.

To examine the impact of 8 weeks of low-volume resistance training with or without personalized blood flow restriction on measure of muscle mass, strength, quality, and bioenergetics. We will use high-load resistance training as a reference control. We will measure muscle mass using Dual Energy X-Ray Absorptiometry, muscle strength using isokinetic testing. We will normalize knee extensor strength to lower limb lean mass to quantify muscle quality. We will also use near infrared spectroscopy and oxygen recovery kinetics to measure mitochondrial oxidative capacity in the vastus lateralis.

Eccentric lower extremity training (ELET) programs are accepted as a viable way to help prevent injury in elite athletes (1). Additionally, blood flow restriction (BFR) has been reported in the clinical setting to help rehabilitate and prevent lower extremity injury in patients with orthopaedic conditions (2, 3), and has shown promise as a valuable tool for both athletic injury prevention and rehabilitation (4, 2). Additionally, subjective accounts suggest there is less resulting muscle damage and/or soreness compared to ELET (5). Hypothesis 1: A single bout of lower extremity eccentric exercise with BFR will reduce acute muscle damage in elite athletes and young healthy adults compared to a single bout of lower extremity eccentric exercise without BFR (1). Hypothesis 2: 6-week lower extremity eccentric training program with BFR will result in greater muscle hypertrophy, strength, and reduced fatigability in both elite athletes and young healthy adults when compared to a 6-week eccentric training program without BFR.

The purpose of this study is to evaluate the effectiveness of physical therapy (PT) plus BFR training compared to PT alone (without BFR training) after ACL reconstruction in patients who require extended limited weight bearing through assessment of patient reported outcomes and functional testing. The hypothesis is that PT plus BFR training will mitigate the loss of quadriceps muscle cross-sectional area, strength, and function while also improving early clinical and functional results.

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The purpose of this study is to examine the effect that blood flow restriction training will have on patients with concussion who demonstrate an intolerance to physical activity. Progressive exercise training has been shown to effectively reduce the effects of concussion and facilitate return to academic and athletic activities. In many cases, exercises intolerance is present in these patients which hinders progression. In musculoskeletal conditions, blood flow restriction training, when combined with low load exercise, has been shown to produce similar gains as high load exercises. If a patient being treated for concussion can tolerate low load exercise without concussive symptoms, then blood flow restriction may increase exercise gains by facilitating autonomic responses similar to high load training. This study will explore this hypothesis in patients between the ages of 14 and 30 who are referred for physical therapy intervention which is the standard of care at Duke Sports Sciences Concussion Clinic. Blood flow restriction training is also used in multiple patient populations at Duke Sports Physical Therapy without adverse events.

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The objective of this study is to evaluate the effects of BFR training on patient reported outcome measures, shoulder strength & range of motion, and shoulder muscle girth in patients following glenoid labral repair. The investigators hypothesize that participants receiving BFR with rehabilitation will have greater improvements in patient reported outcome measures, shoulder strength, range of motion, and shoulder muscle girth than participants who are treated without BFR. Patients between the ages of 18 and 55 who had a superior labrum anterior to posterior (SLAP) repair, anterior labral repair, anterior capsulorrhaphy, or posterior labral repair will be screened for participation in this study. Participants will be randomized in a 1:1 ratio to receive standard physical therapy with blood flow restriction training or without blood flow restriction. Participants will receive standard of care rehabilitation for labral repair regardless of group assignment. The length of each physical therapy session will be approximately one hour. The BFR and control group will perform leg press and leg extension exercises prior to shoulder strengthening. The resistance for both groups will be set as 30% of one repetition maximum (1-RM). The goal will be for the participants to perform 4 sets of repetitions sequenced 30, 15, 15, 15 of each exercise, if this is not obtainable then the number of set/repetitions will be decreased. The lower extremity strengthening exercises for this study will be performed by all participants beginning at 4 weeks post-surgery. These exercises will be performed at each physical therapy session for 8 consecutive weeks (approximately 2 sessions/week). Standard rehabilitation will continue at the conclusion of the 8-week intervention for all participants.

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The purpose of this study is to determine the efficacy of blood restriction therapy by comparing increase in muscle mass, strength and pain in patients diagnosed with patellofemoral knee pain that receive blood restriction therapy to patients who receive a placebo.

 

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Blood flow restricted (BFR) exercise has been shown to improve skeletal muscle adaptations to resistance exercise. BFR uses blood pressure cuffs (i.e., tourniquets) to reduce skeletal muscle blood flow during resistance exercise. One benefit of BFR is that skeletal muscle adaptations to resistance exercise training including muscle hypertrophy and increases in strength can be achieved at lower-loads (e.g., 25-30% 1RM), that are often comparable to more traditional resistance training loads (70-85% 1RM). However, the impact that low-load BFR resistance exercise has on muscle quality and bioenergetics is unknown. The present study will examine the impact of 6 weeks of low-load, single-leg resistance exercise training with or without personalized BFR on measures of muscle mass, strength, quality, and mitochondrial bioenergetics. The investigators will recruit and study up to 30, previously sedentary, healthy, college-aged adults (18-40 years). The investigators will measure muscle mass using Dual Energy X-Ray Absorptiometry and muscle strength and endurance using isokinetic testing. The investigators will normalize knee extensor strength to lower limb lean mass to quantify muscle quality. The investigators will also use near infrared spectroscopy (NIRS) to measure mitochondrial oxidative capacity in the vastus lateralis. Finally, the investigators will measure markers of systemic inflammation and markers of muscle damage using commercially available ELISA assays.

 

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This project is designed as a prospective intervention study integrated into the clinical routine of the treatment of OA of the hip. All participating patients are diagnosed with advanced coxarthrosis with clinical indication to receive a total hip arthroplasty surgery. Subjects will be randomized into one of three experimental groups (Control Group, CG0; Active Control Group, CG1; Blood-Flow-Restriction Group, BFR; figure 1). The subjects of CG0 will undergo established clinical routine (no intervention) in congruence to the guidelines of the certified EPZ (Endocert®: Endoprothesenzentrum). Patients of CG1 and BFR will perform a six week prehabilitation protocol, consisting of two exercise session per week. Applied exercise protocol consists of a unilateral leg press exercise which is performed from both legs successively. Where CG1 will perform the exercise protocol only, patients of the BFR group will receive an additional BFR protocol of the lower extremities during the exercise. The postoperative rehabilitation will be performed in congruence to clinical routine, by physical exercise from the first postoperative day until transition into a specific rehabilitation institution.

The addition of blood flow restriction in conjunction with neuromuscular stimulation will result in increased muscle strength as compared to standard workout alone. Primary outcome; strength of bicep curl via 3 rep max with Biodex. Secondary outcome: injury the subsequent season.

 

 

Blood flow restriction training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle strength at low resistance and minimal stress on the nearby joint. Early research further indicates that it improves systemic bone mineral density with change in bone turnover markers. This novel resistance training has the potential to improve muscle strength and bone density in individuals who are medically unable to perform high resistance exercises typically required to improve these attributes. Our study will examine the effect of occlusion training on bone density and function of the upper extremity following a bicep tenodesis. The primary objective of the intervention is to achieve improved bone density and accelerated recovery of upper extremity function as assessed using measures such as validated questionnaires, functional outcome testing, strength testing, and dual energy x-ray absorptiometry.

 

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