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The Effects of Low-intensity Blood-flow Restricted Exercise on Upper Limb Function Following Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03690700
Recruitment Status : Not yet recruiting
First Posted : October 1, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborators:
University of Southern Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
Helge Kasch, Spinal Cord Injury Centre of Western Denmark

Brief 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. Individuals with tetraplegia after SCI experience limited upper extremity function, increased dependency on others when performing activities of daily living (ADL). Recovery of motor function is high clinical priority and crucial for improved ADL outcomes. Clinical trials have not convincingly demonstrated substantial treatment effect on gained motor function, but better classification of patients may reduce variability and enhance sensitivity of assessment methods, this could be achieved by introducing the relatively new "Spinal Cord Ability Ruler" (SCAR) which measures reportedly change in volitional performance in most potential SCI trial participants. 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-intensity 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 promote rehabilitation and scientific research of individuals with T-SCI, developing more meaningful classifications (retrospective and prospective sub studies and training methods (prospective RCT of consecutive SCI in-patients).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Tetraplegia Other: BFRE Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized placebo controlled parallel group study
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Prior to the first training session, participants will be block-randomized to either active BFRE (n=12) or sham BFRE (n=12), (control for gender).

The outcome assessor will be blinded from the randomization.

Primary Purpose: Treatment
Official Title: The Effects of Low-intensity Blood-flow Restricted Exercise on Upper Extremity Neuromuscular Recovery in Individuals With Spinal Cord Injury: A Double-blinded Randomized Control Trial
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: active BFRE
12 consecutive tetraplegic SCI patients are block-randomized to active arm
Other: BFRE

Blood pressure will be measured prior to each session. Active BFRE group train during inflation of the occlusion cuffs placed around the upper arm to 30 % above resting systolic BP. The occlusion pressure of the participants in sham BFRE group will be of 50mmHg.

Subjects from both groups will participate in 45 minutes of low-intensity BFRE (30-40% 1RM) of the upper extremities twice/week for 8 weeks, consisting of 5 minutes warm up using handcycling followed by 4 sets (30x15x15x15) of biceps curl and wrist extension with BFR. Individual contraction duration will be set to 4 seconds; 2-second flexion/2-second extension, measured by a metronome. To ensure no signs of autonomic dysreflexia, blood pressure will be measured immediately at the end of every training session.


Sham Comparator: sham BFRE
12 consecutive tetraplegic SCI patients are block-randomized to sham arm
Other: BFRE

Blood pressure will be measured prior to each session. Active BFRE group train during inflation of the occlusion cuffs placed around the upper arm to 30 % above resting systolic BP. The occlusion pressure of the participants in sham BFRE group will be of 50mmHg.

Subjects from both groups will participate in 45 minutes of low-intensity BFRE (30-40% 1RM) of the upper extremities twice/week for 8 weeks, consisting of 5 minutes warm up using handcycling followed by 4 sets (30x15x15x15) of biceps curl and wrist extension with BFR. Individual contraction duration will be set to 4 seconds; 2-second flexion/2-second extension, measured by a metronome. To ensure no signs of autonomic dysreflexia, blood pressure will be measured immediately at the end of every training session.





Primary Outcome Measures :
  1. SCAR score change [ Time Frame: 1 week before treatment; 4-, 8- and 12-weeks after start of treatment ]
    Changes in SCAR measured by combining scores of SCIM and upper limb motor assessments of ISNCSCI at baseline and follow-up.


Secondary Outcome Measures :
  1. Change in QoL [ Time Frame: 1 week before treatment; 4-,8- and 12-weeks after start of treatment ]
    Self-reported QoL: 36-Item Short Form Survey (SF-36)

  2. Change in functional capacity (COPM) [ Time Frame: 1 week before treatment; 4-, 8- and 12-weeks after start of treatment ]
    Self-reported functional capacity: Canadian Occupational Performance Measure (COPM)

  3. Change in GRASSP [ Time Frame: 1 week before treatment; 4-, 8- and 12-weeks after start of treatment ]
    The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)

  4. Change in MVC for elbow flexion and wrist extension [ Time Frame: 1 week before treatment; 4-, 8- and 12-weeks after start of treatment ]
    Maximum, voluntary, isometric muscle strength measured by a hand-held dynamometer

  5. Change in CSA [ Time Frame: 1 week before treatment; 8- and 12-weeks after start of treatment ]
    Cross sectional area at trained sites measured by ULS and Dexascan/metrical

  6. Change in Spasticity - Changes in the amplitude and latency of H-reflex [ Time Frame: 1 week before treatment; 8- and 12-weeks after start of treatment ]
    H-reflex estimation

  7. Change in Spasticity - Changes in Tardieu [ Time Frame: 1 week before treatment; 8 and 12-weeks after start of treatment ]
    Tardieu

  8. Change in Spasticity - Changes in Modified Ashworth Scale [ Time Frame: 1 week before treatment; 8 and 12-weeks after start of treatment ]
    Modified Ashworth Scale (MAS) measures resistance during passiv soft-tissue stretching and is used as a measure of spasticity. MAS is an ordinal scale from 0-4, 0=No increase in muscle tone, 4=Affected part(s) rigid in flexion or extension

  9. Change in neuroplasticity - Changes in the amplitude and latency of Transcranial Magnetic Stimulation needed to recruit extensor-carpi-radialis and m. biceps brachii motor units [ Time Frame: 1 week before treatment; 8- and 12-weeks after start of treatment ]
    Transcranial Magnetic Stimulation

  10. Change in self-reported, neuropathic pain level [ Time Frame: 1 week before treatment; 4-, 8- and 12-weeks after start of treatment ]
    Visual-Analogue-Scale (VAS) is a valdidated, subjective measure for acute and chronic neuropathic pain. Scores are recorded by making a mark on a 100 mm straight horizontal line that represents a continuum "no pain" (0mm) and "pain as bad as it could be" (100mm). Neuropathic pain level during the past week will be documented.

  11. Change in medication [ Time Frame: 1 week before treatment; 8 weeks after start of treatment ]
    Electronical Medication List: Patient usage of medication (pain, spasticity, sleep, bladder, bowel



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with tetraplegia
  • Duration of SCI > 1 month, between 18 and <65 years of age
  • Exhibit a grade 3 or 4 muscle function of the elbow flexors and wrist extensors
  • Admitted at SCIWDK
  • Classification of grades A, B, C or D on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale
  • Understands Danish in writing and speech.

Exclusion Criteria:

  • Substance abuse
  • Severe mental illness
  • Uncontrolled hypertension
  • Severe arteriosclerosis, coronary arterial disease
  • Uncontrolled autonomic dysreflexia
  • Deep venous thrombosis (or severe coagulation dysfunction)
  • Collagen diseases such as Ehlers-Danlos Syndrome and Marfan's Syndrome
  • Need for day-time respirator support.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690700


Contacts
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Contact: Anette B Jønsson, Sci San, PT 78446156 ext +45 anjoss@rm.dk
Contact: Helge Kasch, MD, PhD 78446177 ext +45 helgkasc@rm.dk

Sponsors and Collaborators
Spinal Cord Injury Centre of Western Denmark
University of Southern Denmark
Aarhus University Hospital
Investigators
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Principal Investigator: Helge Kasch, MD, PhD Spinal Cord Injury Centre of Western Denmark

Publications:

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Responsible Party: Helge Kasch, Research Director, Senior Consultant Research Neurologist, Associate Professor; PhD, Spinal Cord Injury Centre of Western Denmark
ClinicalTrials.gov Identifier: NCT03690700     History of Changes
Other Study ID Numbers: SpinalCICWD
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Helge Kasch, Spinal Cord Injury Centre of Western Denmark:
BFR Exercise
Spinal Cord Injury
Tetraplegia
Neuromuscular Recovery
Randomized controlled study
Physical Function
Quality of Life

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations
Signs and Symptoms