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

25. juni 2026 opdateret af: Karen Hux, Ph.D., Quality Living, Inc.

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

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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68104
        • Quality Living, Inc.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Adfærdsmæssigt: Blood 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.
Andre navne:
  • BFR
Aktiv komparator: 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.
Adfærdsmæssigt: Blood 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.
Andre navne:
  • BFR

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Torque in Newton-meters
Tidsramme: Three consecutive days pre- and post-treatment
Rotational force exerted when contracting the target muscle group
Three consecutive days pre- and post-treatment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional Independence Measure rating
Tidsramme: Three consecutive days pre- and post-treatment
The Functional Independence Measure (FIM) is a seven-point scale (i.e., 1=total assistance, 7=complete independence) for quantifying the support needed for a participant to perform a designated functional task.
Three consecutive days pre- and post-treatment
Borg category-ratio 10 Rating of Perceived Exertion scale
Tidsramme: Three consecutive days pre- and post-treatment
The Borg category-ratio 10 Rating of Perceived Exertion scale (Borg) provides a means for participants to rate their perceived effort during functional task performance (0=no exertion; 10=highest effort possible).
Three consecutive days pre- and post-treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Quality Living, Inc.

Efterforskere

  • Studieleder: Karen Hux, Ph.D., Quality Living, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BFR exercise frequency

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Ingen

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Ingen

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