Blood Flow-Restricted Exercise for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal frequency of blood flow-restricted exercise (a specialized exercise technique) each week to help individuals with incomplete spinal cord injuries regain strength and independence. Participants will exercise either two or three times a week for eight weeks to identify which schedule better improves muscle strength and eases daily tasks. The trial seeks individuals already receiving spinal cord injury treatment at Quality Living, Inc., who can speak English and follow instructions. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance rehabilitation strategies for spinal cord injuries.
What prior data suggests that blood flow-restricted exercise is safe for spinal cord injury patients?
Research has shown that blood flow-restricted exercise (BFRE) is generally safe for people with spinal cord injuries. Several studies have found that this exercise does not increase the risk of serious problems like blood clots or severe pain. For example, one study found that BFRE does not put extra stress on the heart or cause significant discomfort during exercise.
Other research supports these findings, suggesting that people with partial spinal cord injuries can safely perform BFRE. Notably, these studies have reported no serious side effects. While these results are encouraging, individual experiences may vary.12345Why are researchers excited about this trial?
Researchers are excited about blood flow-restricted exercise for spinal cord injury because it offers a unique approach to rehabilitation by targeting muscle groups on both sides of the body with specific, controlled exercises. Unlike standard physical therapy, which may involve general exercise routines, this method uses pressure cuffs to restrict blood flow, potentially enhancing muscle strength and growth even with low-intensity exercise. Additionally, if participants struggle to complete the exercise sets, electrical stimulation can assist them, ensuring muscle engagement and potentially improving outcomes. This innovative technique could provide more efficient and effective muscle rehabilitation for individuals with spinal cord injuries.
What evidence suggests that blood flow-restricted exercise is effective for spinal cord injury?
This trial will evaluate blood flow-restricted exercise (BFRE) for people with spinal cord injuries (SCI). Participants will join one of two treatment groups: receiving BFRE either two times per week or three times per week. Studies have shown that BFRE can safely enhance muscle strength in people with SCI. Research indicates that BFRE can improve both muscle strength and overall physical ability. One study found significant improvements in muscle strength, with effect sizes of 1.13, 0.995, and 1.9. Additionally, combining BFRE with regular therapy led to better muscle strength and improved daily activities. While some studies found no major difference compared to placebo exercises, the overall evidence supports BFRE as a promising method to boost muscle strength in SCI patients.23467
Who Is on the Research Team?
Karen Hux, Ph.D.
Principal Investigator
Quality Living, Inc.
Are You a Good Fit for This Trial?
This trial is for adults who have an incomplete spinal cord injury. Participants should be able to take part in exercise sessions and complete strength and function tests before and after the treatment period.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment Evaluation
Participants complete pre-treatment evaluation sessions to establish baseline muscle strength, level of independence, and perceived exertion
Treatment
Participants receive blood flow-restricted exercise treatment either two or three times weekly for eight weeks
Post-treatment Evaluation
Participants complete post-treatment evaluation sessions to measure changes in muscle strength, level of independence, and perceived exertion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blood flow-restricted exercise
Trial Overview
The study compares two schedules of blood flow-restricted exercise—either twice or three times a week for eight weeks—to see which helps improve muscle strength, independence, and effort needed for certain tasks after incomplete spinal cord injury.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants will received blood flow-restricted exercise treatment two times per week for eight weeks. Treatment will target one muscle group both on the left and right side of the body. Participants will complete four sets of 20 muscle contraction repetitions with a 30-second rest period between each set. If a participant can not complete all 20 repetitions in a set, they will receive electrical stimulation to the muscle to prompt performance of the remaining set contractions.
Participants will received blood flow-restricted exercise treatment three times per week for eight weeks. Treatment will target one muscle group both on the left and right side of the body. Participants will complete four sets of 20 muscle contraction repetitions with a 30-second rest period between each set. If a participant can not complete all 20 repetitions in a set, they will receive electrical stimulation to the muscle to prompt performance of the remaining set contractions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Quality Living, Inc.
Lead Sponsor
Citations
The Feasibility and Effects of Low-load Blood-flow ...
Based on existing scientific evidence, BFRE is acknowledged as a safe regime without serious side effects. Previously, the method has shown ...
Feasibility and safety of two weeks of blood flow restriction ...
Reduced muscle strength and function are common after spinal cord injury (SCI). While low-load blood flow restriction exercise (BFRE) enhances ...
Efficacy of Blood Flow Restriction Exercise for Improving ...
In conclusion, there was no significant difference in the effect of LL-BFRE and sham exercise on muscle strength and physical function in individuals with SCI.
Blood Flow Restriction Exercise for Those With SCI
In general, effect size of BFR exercise training on muscle strength and cross sectional from several investigations were 1.13, 0.995 and 1.9.
The Feasibility of Blood Flow Restriction Exercise in ...
Results suggest that controlled BFR exercise can be safely performed by individuals with iSCI without added cardiovascular strain or heightened pain.
Feasibility and safety of two weeks of blood flow restriction ...
Conclusion: BFRE was feasible in an SCI rehabilitation setting despite a low recruitment rate. BFRE imposed no heightened risk of DVT or severe ...
The Feasibility and Effects of Low-load Blood-flow ...
Based on existing scientific evidence, BFRE is acknowledged as a safe regime without serious side effects. Previously, the method has shown ...
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