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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Quality Living, Inc.
Study ID
NCT07678437
Status
Enrolling By Invitation

Conditions

  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Blood flow-restricted exercise — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Two times per week
    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.
  • Active Comparator: Three times per week
    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.

Primary Outcome Measure

Torque in Newton-meters [ Time Frame: Three consecutive days pre- and post-treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Quality Living, Inc.OmahaNebraska68104-

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