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Trial registered on ANZCTR


Registration number
ACTRN12618000018213
Ethics application status
Approved
Date submitted
12/12/2017
Date registered
11/01/2018
Date last updated
11/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electrical stimulation-muscle strength training in people with spinal cord injury
Scientific title
Can high-intensity Neuromuscular electrical stimulation (NMES) strength training improve muscle strength and mass, physical health and quality of life in people with spinal cord injury?
Secondary ID [1] 293592 0
None
Universal Trial Number (UTN)
U1111-1206-5386
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 305844 0
Condition category
Condition code
Neurological 305054 305054 0 0
Other neurological disorders
Injuries and Accidents 305055 305055 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NMES was delivered by a high-voltage constant-current electrical stimulator (400 V, DS7A, Digitimer Ltd., Welwyn Garden City, UK) under the same conditions as the assessment through four self-adhesive stimulation electrodes (Axelgaard, PALS, USA) placed over the rectus femoris (RF), vastus lateralis (VL), and vastus medialis (VM). Two 5×10 cm electrodes were placed over RF and one 5×5 electrode was placed on each of the VM and VL approximately at their motor points using a split end cable, to increase the surface area of stimulation. The electrodes were placed to elicit the greatest twitch response with a low stimulation intensity.
Each session commenced with a “warm-up” period consisting of paired electrical square-wave stimuli (two 1000 µs square-wave pulses, 5–ms interpulse interval) followed by a maximum of three tetanic trains (tau-t,40mA) delivered to each leg separately every 20 s while the stimulation current was increased from 30 mA in 10-mA increments until a plateau in the maximum peak twitch torque was observed or the maximal current intensity was 99 mA. This plateau was defined as the maximal peak twitch torque (tau-tw,p) and was used as the target torque during the training session. Subsequently, a tetanic train of NMES at 40 mA (tau-t,40mA) was delivered followed by a maximum of three trains of NMES performed at different stimulation current intensities until reaching the closest value to the target torque.
After the warm-up period the NMES session commenced with electrically-evoked muscle contractions being elicited at the target torque for 5 sets of 10 repetitions on each leg, with a 1-min rest between sets. To determine the actual training intensity either one of two methods was used. The first method was by evoking the maximal peak twitch torque (tau-tw,p) and setting the current so the tetanic torque was equal to tau-tw,p. However, if tau-tw,p showed a decrease compared to previous sessions, a second method was used whereby the starting current was set to be equal to the highest current used in the previous training session. Within each session, the current was increased by 2 mA per each set of 10 repetitions to maintain a high torque production as fatigue developed; thus, if the second method was chosen, the current selected for set 1 was the same as that used in the final set of the previous session. Using this method, the torque produced in set 1 of training was always higher than that performed in any set of the previous session, so the evoked torque increased incrementally.
All training sessions were conducted by the same trained researcher, who was a senior Physiotherapist and were additional to any other rehabilitation exercise. The participants were asked to keep their physical training routine consistent for the duration of the experiment.
Training was performed twice a week (with at least one rest day between) for 12 weeks. All assessments were completed at -1 weeks (“Control period”), 0 weeks (0-wk) and 12 weeks (12-wk), except for resting blood samples which were taken at 0-wk and 12-wk only. Post-training assessments were taken 4-6 days after the last training session to allow for recovery of acute, residual effects of intense exercise. The procedures used in this study were similar from the methodology used in a previous study in people with spinal cord injury (SCI).
Intervention code [1] 299845 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304216 0
Knee-extension torque measurements using an isokinetic dynamometer (Biodex System 3 Pro Ronkonkoma, NY).
Timepoint [1] 304216 0
At pre-baseline (-1 wk, control period), baseline (0-wk) and 4-6 days after the last training session (12-wk)
Primary outcome [2] 304217 0
Muscle cross-sectional area of quadriceps femoris (CSA-QF) using B-mode axial-plane ultrasonography (Aloka SSD-a10, software number 6.1.09, Aloka Co., Ltd., Tokyo, Japan).
Timepoint [2] 304217 0
At pre-baseline (-1 wk, control period), baseline (0-wk) and 4-6 days after the last training session (12-wk)
Primary outcome [3] 304218 0
Blood biomarkers for blood lipid profile.
Timepoint [3] 304218 0
At baseline (0-wk) and 4-6 days after the last training session (12-wk)
Secondary outcome [1] 341275 0
Spasticity measure using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)
Timepoint [1] 341275 0
At pre-baseline (-1 wk, control period), baseline (0-wk) and 4-6 days after the last training session (12-wk)
Secondary outcome [2] 341531 0
Blood biomarkers: C-reactive protein (CRP) concentration.
Timepoint [2] 341531 0
At baseline (0-wk) and 4-6 days after the last training session (12-wk)
Secondary outcome [3] 341532 0
Quality of life measure (QoL) using the Quality of life Index (QLI) for people with spinal cord injuries (SCI).
Timepoint [3] 341532 0
At pre-baseline (-1 wk, control period), baseline (0-wk) and 4-6 days after the last training session (12-wk).

Eligibility
Key inclusion criteria
Inclusion criteria: age 18-65 years; SCI longer than 6 months that led to complete or incomplete paraplegia or tetraplegia; level of injury between C2 and L5; AIS (American Spinal Cord Injury Association Impairment Scale) A, B, C or D; have medical permission to enrol in an intensive exercise program; and able to participate in the program over a 14-week period.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute phase of injury (less than 6 months from injury); ventilator dependent, other associated neurological disease; and complications such as severe urinary infection, pressure ulcers, previous lower-limb fractures or any other health condition that may constrain the participation in an exercise program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Wilcoxon non-parametric tests were used to compare changes in control and experimental periods (-1, 0 and 12-weeks) in peak twitch torque (tau-tw,p), evoked tetanic torque (tau-t,40mA), cross-sectional area (CSA), body composition, biochemical measures for lipid profile and CRP, symptoms of spasticity and QoL outcomes. Reliability of the outcome measures between the control period (-1-wk) and 0-wk was assessed using the intra-class correlation coefficient (ICC). Statistical significance was set at an alpha level of equals or less than 0.05 and values are reported as mean and SD.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
15/03/2016
Date of last data collection
Anticipated
Actual
1/08/2016
Sample size
Target
10
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 298209 0
University
Name [1] 298209 0
Edith Cowan University
Country [1] 298209 0
Australia
Primary sponsor type
Individual
Name
Vanesa Bochkezanian
Address
Central Queensland University. Bruce Highway, North Rockhampton, Queensland, Australia (4702)
Country
Australia
Secondary sponsor category [1] 297308 0
Charities/Societies/Foundations
Name [1] 297308 0
Spinal Cord Injuries Australia
Address [1] 297308 0
1 Jennifer St, Little Bay, NSW, Australia (2036).
Country [1] 297308 0
Australia
Secondary sponsor category [2] 297311 0
Individual
Name [2] 297311 0
Anthony J Blazevich
Address [2] 297311 0
Edith Cowan University, 270 Joondalup drive, Joondalup, Western Australia (6027).
Country [2] 297311 0
Australia
Secondary sponsor category [3] 297312 0
Individual
Name [3] 297312 0
Robert U Newton
Address [3] 297312 0
Edith Cowan University, 270 Joondalup drive, Joondalup, Western Australia (6027).
Country [3] 297312 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299216 0
Edith Cowan University Research Ethics Commitee
Ethics committee address [1] 299216 0
Ethics committee country [1] 299216 0
Australia
Date submitted for ethics approval [1] 299216 0
14/01/2015
Approval date [1] 299216 0
27/01/2015
Ethics approval number [1] 299216 0
11623

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2263 2263 0 0
/AnzctrAttachments/374158-March Information letter S4 VB.docx (Participant information/consent)

Contacts
Principal investigator
Name 79690 0
Dr Vanesa Bochkezanian
Address 79690 0
Central Queensland University. Bruce Highway. North Rockhampton. QLD. Australia (4702)
Country 79690 0
Australia
Phone 79690 0
+61 7 49306453
Fax 79690 0
Email 79690 0
v.bochkezanian@cqu.edu.au
Contact person for public queries
Name 79691 0
Vanesa Bochkezanian
Address 79691 0
Central Queensland University. Bruce Highway. North Rockhampton. QLD. Australia (4702)
Country 79691 0
Australia
Phone 79691 0
+61 7 49306453
Fax 79691 0
Email 79691 0
v.bochkezanian@cqu.edu.au
Contact person for scientific queries
Name 79692 0
Anthony J Blazevich
Address 79692 0
Edith Cowan University, 270 Joondalup drive. Joondalup, Western Australia (6027).
Country 79692 0
Australia
Phone 79692 0
+61 8 63045472
Fax 79692 0
Email 79692 0
a.blazevich@ecu.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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