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

NCT03690700 | Unknown DMC

• 1 other identifier: BFRE_SCI
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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. 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

Keywords

BFR Exercise; Spinal Cord Injury; Neuromuscular Recovery; Randomized controlled study; Physical Function

Outcome Measures

Primary Outcomes (1)

• Changes in MVC

  Changes in maximum, voluntary, isometric muscle strength (Muscle torque, MVC) of the m. quadriceps and hamstrings from baseline to follow-up

  1 week before treatment; 4-, 8- and 12-weeks after start of treatment

Secondary Outcomes (12)

• Change in Rate of force development (RFD)

  1 week before treatment; 4-,8- and 12-weeks after start of treatment

• Change in muscle and tendon thickness

  1 week before treatment; 4-, 8- and 12-weeks after start of treatment

• Change in The Spinal Cord Ability Ruler (SCAR)

  1 week before treatment; 4-, 8- and 12-weeks after start of treatment

• Timed Up & Go Test (TUG)

  1 week before treatment; 4-, 8- and 12-weeks after start of treatment

• Timed 10 Meter Walk Test

  1 week before treatment; 4-, 8- and 12-weeks after start of treatment

Study Arms (2)

active BFRE

ACTIVE COMPARATOR

14 consecutive SCI patients are block-randomized to active arm

Other: BFRE

sham BFRE

SHAM COMPARATOR

14 consecutive SCI patients are block-randomized to sham arm

Other: BFRE

Interventions

BFRE OTHER

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.

active BFRE; sham BFRE

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Duration of SCI \> 1 year,
• years of age or older
• Exhibit a grade 2, 3 or 4 muscle function of the knee flexors and/or extensors
• Classification of grades A, B, C or D on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale
• Cognitive ability to follow instructions

You may not qualify if:

• Substance abuse
• Severe mental illness
• Uncontrolled hypertension
• Severe arteriosclerosis, coronary arterial disease
• History of severe autonomic dysreflexia
• Deep venous thrombosis (or severe coagulation dysfunction)
• Collagen diseases such as Ehlers-Danlos Syndrome and Marfan's Syndrome
• Severe neuropathies

Sponsors & Collaborators

• Spinal Cord Injury Centre of Western Denmark: lead
• University of Southern Denmark: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

The Spinal Cord Injury Centre of Western Denmark

Viborg, 8800, Denmark

RECRUITING

Related Publications (27)

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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

• Jørgen Feldbæk Nielsen, MD,PhD,Prof.

  Spinal Cord Injury Centre of Western Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anette B Jønsson, Sci San, PT

CONTACT

78446152; anjoss@rm.dk

Jørgen Feldbæk Nielsen, MD,PhD,Prof.

CONTACT

78419043; joerniel@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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 participants will be blinded from the randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, Professor; PhD

Model Details: randomized placebo controlled parallel group study

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 1, 2018
• Study Start: May 1, 2020
• Primary Completion: February 28, 2024
• Study Completion: October 31, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)