The Feasibility and Effects of Low-load Blood-flow Restricted Exercise Following Spinal Cord Injury

NCT03690700 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-03-31

No results posted yet for this study

Summary

Spinal cord injury (SCI): The World Health Organization estimates an incidence of 250,000 to 500,000 per year worldwide. In Denmark 130 new cases of SCI per year. SCI is a devastating condition: paresis/paralysis of the skeletal muscles below the injury site, partial or complete inability to walk, move and/or feel. Other sequelae are: infections, lifestyle diseases (cardiovascular, diabetes, nephrologic disease), mental wellbeing/suicide-risk profoundly raised , quality of life, next-of-kin affection. Recovery of motor function is high clinical priority and crucial for improved ADL outcomes. Strength training regimens have shown improved muscle strength in healthy subjects using near-maximal voluntary effort contractions, and few studies have demonstrated similar effects in a SCI population. Atrophy and fatigability and spasticity may reduce practical implementation for rehabilitation. Therefore, low-load blood-flow restricted exercise (BFRE) may prove beneficial as supplement to traditional rehabilitation, increasing muscle strength and inducing hypertrophy in healthy persons. BFRE is performed as low-intensity strength training (20-30 % of max) while simultaneously involving the use of circumferential placement of cuffs during exercise, to maintain arterial inflow to the muscle while preventing venous return. Based on existing scientific evidence, BFRE is acknowledged as a safe regime without serious side effects. Previously, the method has shown increased muscle strength and inducing skeletal muscle hypertrophy in addition to improvement in gait performance in individuals with various diseases causing reduced mobility. Purposes of this PhD project: to investigate the feasibility and effects of BFRE in individuals living with the consequences of SCI.

Conditions

  • Spinal Cord Injuries

Interventions

OTHER

BFRE

BFR will be performed in the aBFRE group by use of pneumatic occlusion cuffs placed proximally on the thigh close to the inguinal fold, using an occlusion pressure corresponding to 40 % of seated arterial occlusion pressure (AOP). The individual AOP will be documented at baseline using doppler ultrasound (Siemens ACUSON S2000TM). Previous studies have shown that this pressure level can promote significant muscle adaptations to a similar degree and are associated with significantly less discomfort than higher occlusion pressures. The occlusion pressure of the participants in sham BFRE group will be 10mmHg.

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • Spinal Cord Injury Centre of Western Denmark

    lead OTHER

Principal Investigators

  • Jørgen Feldbæk Nielsen, MD,PhD,Prof. · Spinal Cord Injury Centre of Western Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2024-02-28
Completion
2024-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690700 on ClinicalTrials.gov