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Effect of Blood Flow-restricted Exercise Frequency on Strength Recovery Following Incomplete SCI

Effect of Blood Flow-restricted Resistance Exercise Frequency on Strength Recovery Following Incomplete Cervical Spinal Cord Injury

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07678437
Enrollment
20
Registered
2026-07-01
Start date
2026-07-15
Completion date
2027-07-01
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

spinal cord injury, intervention, blood flow-restricted exercise, functional recovery, muscle strength

Brief summary

The goal of this clinical trial is to determine the effect of treatment frequency on the physical recovery of adults with incomplete spinal cord injury. The treatment will last for eight weeks and will occur either either two or three times weekly. The main research questions are: 1. How do changes in muscle strength compare between participants who receive eight weeks of blood flow-restricted exercise two times vs. three times weekly? 2. How do changes in the level of independence performing a selected functional task compare between participants who receive eight weeks of treatment two times vs. three times weekly? 3. How do changes in the perceived exertion needed to perform a functional task compare between participants who receive eight weeks of treatment two times vs. three times weekly? The researchers will compare people receiving treatment two vs. three times per week to see if they differ in the amount of change seen in muscle strength, level of independence performing a functional task requiring use of the targeted muscle group, and/or perceived exertion required to perform the functional task. Participants will: 1. complete three pre-treatment evaluation sessions to establish muscle strength, level of independence performing a functional task, and perceived exertion required to perform a functional task. 2. perform four sets of 20 muscle contraction repetitions of blood flow-restricted exercise on the left and right sides of the body using the targeted muscle group either two times or three times weekly depending on treatment group assignment. 3. complete three post-treatment evaluation sessions to establish muscle strength, level of independence performing a functional task, and perceived exertion required to perform a functional task.

Detailed description

Participants in both treatment groups will receive blood flow-restricted (BFR) intervention for eight weeks. Other than substituting BFR exercises for those typically performed with the target muscle group, a participant's established treatment program will not change with study enrollment. Participants will engage in pre-treatment data collection measuring the strength and functional use of the target muscle group for three consecutive days before beginning the BFR protocol. We will use a dynamometer to measure in Newtons the maximum force a participant can exert with the left and right target muscle. To measure functional use, we will assess the assistance a participant needs to perform a designated functional task using the Functional Independence Measure (FIM) rating scale. Participants will rate their perceived effort with the Borg category-ratio 10 Rating of Perceived Exertion (Borg) scale. Each BFR exercise session will begin with measuring resting blood pressure to ensure it is between 80/50 mmHg and 150/90 mmHg. We will then place a 50% inflated pneumatic cuff either with or without an electrical stimulation (ES) device, as appropriate, on the participant's target limb. The participant will perform 4 sets of 20 low-dose contractions of the target muscle with 30 s rest between sets. We will only use ES supplementation when a participant can not perform additional set repetitions independently. Resistance band placement will increase repetition difficulty as strength increases. The treatment regimen will then repeat with the contralateral limb. We will repeat the measurement of muscle strength and functional task performance for three consecutive days at the conclusion of the eight-week treatment regimen. Again, we will rate the assistance provided for functional task performance using the FIM scale, and the participant will report the effort exerted using the Borg scale.

Interventions

BEHAVIORALBlood flow-restricted exercise

Blood flow-restricted exercise involves performance of low-load contractions of a target muscle group while a pneumatic cuff placed proximally on the limb partially restricts blood flow to muscles and venous return to central circulation.

Sponsors

Quality Living, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* A current client receiving treatment for a spinal cord injury at Quality Living, Inc.

Exclusion criteria

* Does not speak English * Can not follow commands * Recent history of deep vein thrombosis, autonomic dysreflexia, orthostatic hypotension, or cardiovascular disease

Design outcomes

Primary

MeasureTime frameDescription
Torque in Newton-metersThree consecutive days pre- and post-treatmentRotational force exerted when contracting the target muscle group

Countries

United States

Contacts

STUDY_DIRECTORKaren Hux, Ph.D.

Quality Living, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026