Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000415303
Ethics application status
Approved
Date submitted
10/03/2017
Date registered
23/03/2017
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the potential of Hybrid Electrical Stimulation Cycling for aerobic exercise in Persons with Advanced Multiple Sclerosis
Scientific title
Effect of hybrid functional electrical stimulation cycling on aerobic exercise response in persons with advanced multiple sclerosis
Secondary ID [1] 291168 0
None
Universal Trial Number (UTN)
U1111-1192-9588
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 302048 0
Condition category
Condition code
Neurological 301680 301680 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 301681 301681 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research will investigate the cardiopulmonary response elicited from persons with advanced multiple sclerosis during three different modes of aerobic exercise. The three modes are voluntary arm cranking, functional electrical stimulation (FES) cycling and hybrid FES cycling which is a combination of FES cycling and arm cranking. Each mode of exercise will be investigated with a separate exercise trial (i.e. trial A, B, C). Measurement trial will be separated by between two days to a week. Prior to the 3 trials, participants will perform a maximum arm cranking exercise test trial to determine their arm cranking capacity. Throughout each trial the aerobic exercise response will be monitored through routine non-invasive measures of cardiorespiratory metabolism, e.g. oxygen consumption and heart rate. Oxygen consumption and other cardiorespiratory metabolism will be measured by a metabolic cart. Heart rate will be monitored with a standard chest strap heart rate monitor. At the end of each exercise trial participants will be asked how hard the exercise felt and how fatigued they feel on a visual analogue scale.

FES cycling equipment:
Functional electrical stimulation will be performed on the iFES-LCE developed at the University of Sydney which has been specifically modified to suit persons with multiple sclerosis. The iFES-LCE comprised a motorized cycle ergometer (MOTOmed Viva 1), a chair with passive leg restraints, a portable computer and a muscle stimulator. Stimulation is delivered by gel backed surface electrodes (Empi) which will be placed on the quadriceps, hamstrings, and gluteal muscles of each leg. Using instantaneous pedal crank position data, the computer program directs the muscle stimulator to provide stimulation to six muscle groups (left and right gluteals, hamstrings, and quadriceps muscles) at the appropriate times to elicit a smooth cycling pattern. The participants will not contribute voluntarily to the cycling which will be at cadence of 10rpm.

FES cycling familiarisation sessions:
Prior to performing the exercise trials, each participant will perform up to 6 familiarization sessions with FES cycling. Each familiarization session will be 45min duration and will be performed on the iFES-LCE ergometer. Initially the stimulation amplitude will be set at 30 mA, frequency will be 35 Hz and pulse width 300 microseconds. The stimulation will be slowly increased during by the control software over the session until the peak muscle stimulation intensity that can be comfortably tolerated by the participant is reached. The peak stimulation found in these familiarization sessions will be used to set the stimulation intensities for trials A and C.

Maximal arm crank exercise test trial:
Participants will perform an incremental maximum arm crank test on the Monark 881E Arm Ergometer where they will be required to maintain the cranking at 50 rpm. The power output required to turn the cranks will be increased by 5 watts every 2 minutes until the participant cannot maintain the cadence. The maximum power output will be used to set the arm workloads in trials B and C.

Exercise Trials:
Each trial will involve approximately 40 minutes of exercise. Cardiorespiratory metabolism will be measured throughout each trial. The test trials will be conducted by exercise physiology honours students. An experienced exercise scientist will supervise the trials and will have the skills, training, and experience to recognize the expected response elicited during the exercise trials.

Trial A - Functional electrical stimulation cycling. Functional electrical stimulation will be performed on the iFES-LCE ergometer for 40min. The electrical stimulation levels determined during the familiarization sessions will be the maximum stimulation applied during this trial (e.g. defined as 100% stimulation). The FES intensity will be increased gradually in four steps during the session to reach maximum stimulation at 35min. For each step, FES intensity will be slowly increased for five minutes, then held constant for five minutes. This procedure will be repeated 3 more times to reach maximum stimulation.

Trial B - Arm cranking - Participants will warm up at 20% of their assessed maximal arm crank power, then arm crank for four minutes at 40%, 60%, 80%, and 100% of the maximal power achieved in the maximal arm crank trial. There will be 6 minutes rest between each arm cranking workload. Excluding warmup, this test will comprise a total of 16 min arm cranking exercise.

Trial C - Hybrid FES exercise (arm crank & FES cycling). The final trial will involve the superimposed arm cranking trial and the FES leg cycling trial. Cardiorespiratory measurements will be monitored as in trial A (FES cycling) and B (arm cranking). In total this trial will is comprised of 24min FES cycling and 16min of hybrid exercise where arm cranking and FES cycling will be performed simultaneously.

Intervention adherence or fidelity are not be assessed for these brief research trials.. Participants will be rescheduled if they are unable to attend a research session. Participants are able to withdraw from the trials at any time.
Intervention code [1] 297537 0
Treatment: Devices
Intervention code [2] 297574 0
Lifestyle
Comparator / control treatment
The standard comparator for this repeated measured comparison is trial A, i.e. the arm cranking exercise trial. Arm cranking is readily available in the community as opposed to FES cycling or Hybrid which involves specialized knowledge and expensive technology.
Control group
Active

Outcomes
Primary outcome [1] 301079 0
Peak oxygen consumption during each exercise trial. Measured by breath by breath analysis using a metabolic cart.
Timepoint [1] 301079 0
Measured continuously throughout each trial
Secondary outcome [1] 331679 0
Maximum heart rate during each exercise trial. Measured by Polar watch and electrode strap
Timepoint [1] 331679 0
measured continuously throughout each trial
Secondary outcome [2] 331680 0
perception of fatigue (Likert scale)
Timepoint [2] 331680 0
Immediately Post trial A, B, & C
Secondary outcome [3] 332642 0
Perception of effort fatigue (modified Borg 10-point scale)
Timepoint [3] 332642 0
Immediately Post Trial A, B, & C

Eligibility
Key inclusion criteria
Diagnosis of advanced multiple sclerosis - EDSS 6.0-8.5 inclusive
Not able to walk 25m without the assistance of a cane
Ability to perform arm cranking exercise
Aged 18-65 years
Male or female
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if their doctor believes there is any reason they cannot safely participate in this study due to other conditions or absolute contradictions to exercise.
People who have contraindications to functional electrical stimulation cycling exercise which include:
i. having an a demand-type implanted cardiac pacemaker or defibrillator or deep brain stimulator
ii. people who reacts very negatively to the experience or to the sensation of stimulation.
iii. people with undiagnosed pain.
iv. people who cannot provide adequate feedback concerning the level of stimulation
v. people who have a serious cognitive impairment.
vi. people who have had a multiple sclerosis exacerbation in the last three months.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Safety/efficacy
Statistical methods / analysis
Ten sedentary persons with advanced MS will undertake the trials in this research. There is no data on this for persons with advanced MS, so statistical calculations cannot be performed. It is thought that 10 subjects should be enough to show a significant difference based on prior data from persons with spinal cord injury (SCI). It is believed that in MS the relative magnitude of the aerobic response to arm cranking and FES cycling will be similar to that seen in SCI. In SCI arm cranking exercise gives a superior aerobic workout to FES cycling and prior research that performed by the principal investigator in persons with SCI has demonstrated that 10 participants should provide meaningful data. The results will be relevant not only with respect to statistical power but also of clinical relevance.

Descriptive statistics will be used to describe the maximum and average responses elicited for each mode of exercise and the cardiorespiratory measures recorded. Statistical analysis using ANOVA will determine if the mode of exercise has a significant effect on each measure. When significant main effects are found paired t-tests will be used to explore differences between exercise modes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
1/02/2018
Date of last participant enrolment
Anticipated
1/08/2019
Actual
Date of last data collection
Anticipated
1/09/2019
Actual
Sample size
Target
10
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295611 0
University
Name [1] 295611 0
The Univeristy of Sydney
Country [1] 295611 0
Australia
Primary sponsor type
Individual
Name
Dr Che Fornusek
Address
C103
Faculty of Health Sciences
The University of Sydney
75 East St
Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 294446 0
None
Name [1] 294446 0
Address [1] 294446 0
Country [1] 294446 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296929 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 296929 0
THE UNIVERSITY OF SYDNEY
Level 2 Margaret Telfer Building (K07)
The University of Sydney
NSW 2006
Ethics committee country [1] 296929 0
Australia
Date submitted for ethics approval [1] 296929 0
07/10/2016
Approval date [1] 296929 0
08/02/2017
Ethics approval number [1] 296929 0
2016/845

Summary
Brief summary
Aims: The objective of this project is to advance knowledge on the aerobic exercise options that are available for persons with advanced MS. Currently persons with advanced MS have severely reduced exercise options and little is known about the benefits of those exercises. Much of the information available is anecdotal and persons with MS and practitioners are in need of clearer guidelines and information. The specific aim of this research project is to explore the potential of electrical stimulation exercise to expand the aerobic exercise options available for persons with advanced MS. In this project we will investigate the relative benefits and drawbacks of arm cranking, FES cycling, and hybrid FES exercise in persons with advanced MS. We will measure the cardiorespiratory and cardiovascular responses, the fatigue levels induced, and the effort required.

Intervention: Ten persons with advanced multiple sclerosis will participate in three exercise trials using different modes of aerobic exercise. The trials will be performed at the Faculty of Health Sciences, University of Sydney. Prior to the exercise trials participants will complete 1-6 practice sessions to become familiarized with FES cycling and a maximum arm crank test. The three trials are an arm cranking trial, an FES cycling trial and a Hybrid FES cycling trial (which involves simultaneous voluntary arms and FES leg cycling exercise). Each trial will be separated by between 2 days to a week. During each trial routine non-invasive measures of cardiorespiratory metabolism will be performed. Oxygen consumption and other cardiorespiratory metabolism will be measured by a metabolic cart. Heart rate will be monitored with a standard chest strap heart rate monitor. At the end of each exercise trial participants will be asked how hard the exercise felt and how fatigued they feel on a visual analogue scale.

Hypothesis: It is predicted that hybrid FES exercise will result in the greatest aerobic exercise response of the three exercise modes. Therefore, the primary hypothesis tested during this project is that: “Hybrid FES exercise elicits greater oxygen consumption than either arm cranking exercise or FES cycling exercise.” We will also examine if there is a difference in the heart rate, tolerance, perceived exertion, and the fatigue response between the three different exercise modes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72462 0
Dr Che Fornusek
Address 72462 0
C103, Faculty of Health Science, University of Sydney 75 East Street Lidcombe, NSW 2141
Country 72462 0
Australia
Phone 72462 0
+61293519200
Fax 72462 0
+61293519204
Email 72462 0
Che.Fornusek@sydney.edu.au
Contact person for public queries
Name 72463 0
Dr Che Fornusek
Address 72463 0
C103, Faculty of Health Science, University of Sydney 75 East Street Lidcombe, NSW 2141
Country 72463 0
Australia
Phone 72463 0
+61293519200
Fax 72463 0
+61293519204
Email 72463 0
Che.Fornusek@sydney.edu.au
Contact person for scientific queries
Name 72464 0
Dr Che Fornusek
Address 72464 0
C103, Faculty of Health Science, University of Sydney 75 East Street Lidcombe, NSW 2141
Country 72464 0
Australia
Phone 72464 0
+61293519200
Fax 72464 0
+61293519204
Email 72464 0
Che.Fornusek@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We did not ask for Ethical clearance for this release of data from participants


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2209Ethical approval    372351-(Uploaded-29-05-2019-11-25-32)-Study-related document.pdf



Results publications and other study-related documents

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