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

NCT07678437 | Enrolling By Invitation

• 1 other identifier: BFR exercise frequency
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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. 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. 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?
4. 4.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.
5. 5.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.
6. 6.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.

Conditions

Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Torque in Newton-meters

  Rotational force exerted when contracting the target muscle group

  Three consecutive days pre- and post-treatment

Other Outcomes (2)

• Functional Independence Measure rating

  Three consecutive days pre- and post-treatment

• Borg category-ratio 10 Rating of Perceived Exertion scale

  Three consecutive days pre- and post-treatment

Study Arms (2)

Two times per week

ACTIVE COMPARATOR

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.

Behavioral: Blood flow-restricted exercise

Three times per week

ACTIVE COMPARATOR

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.

Behavioral: Blood flow-restricted exercise

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.

Also known as: BFR

Three times per week; Two times per week

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Quality Living, Inc.: lead

Study Sites (1)

Quality Living, Inc.

Omaha, Nebraska, 68104, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Karen Hux, Ph.D.

  Quality Living, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)