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
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:
- How do changes in muscle strength compare between participants who receive eight weeks of blood flow-restricted exercise two times vs. three times weekly?
- 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?
- 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:
- 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.
- 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.
- 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Nebraska
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Omaha, Nebraska, Forente stater, 68104
- Quality Living, Inc.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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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.
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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 navn:
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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.
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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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Torque in Newton-meters
Tidsramme: Three consecutive days pre- and post-treatment
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Rotational force exerted when contracting the target muscle group
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Three consecutive days pre- and post-treatment
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Independence Measure rating
Tidsramme: Three consecutive days pre- and post-treatment
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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.
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Three consecutive days pre- and post-treatment
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Borg category-ratio 10 Rating of Perceived Exertion scale
Tidsramme: Three consecutive days pre- and post-treatment
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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).
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Three consecutive days pre- and post-treatment
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Karen Hux, Ph.D., Quality Living, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BFR exercise frequency
Plan for individuelle deltakerdata (IPD)
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