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Trial registered on ANZCTR


Registration number
ACTRN12617000784314
Ethics application status
Approved
Date submitted
14/05/2017
Date registered
29/05/2017
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A hybrid functional electrical stimulation training program for persons with advanced multiple sclerosis
Scientific title
Exploring the efficacy of a hybrid functional electrical stimulation training program to improve maximum oxygen consumption in advanced multiple sclerosis
Secondary ID [1] 291439 0
Nil known
Universal Trial Number (UTN)
U1111-1194-2040
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 302501 0
Condition category
Condition code
Neurological 302057 302057 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 302385 302385 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study will investigate the possible improvements to aerobic fitness that can be elicited in persons with advanced multiple sclerosis from 12 weeks of hybrid Functional Electrical Stimulation (FES) exercise training. This involves a combination of FES cycling and arm cranking.

Prior to the 12 weeks of training, participants will undertake pre-testing, separated by between two days to a week. These will be repeated at the conclusion of the trial and at the midpoint (6 weeks) the incremental arm crank test will be conducted. Participants will be carefully monitored during all tests; the tests will be concluded immediately if the participants appear over fatigued, distressed, or ill. The tests 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 tests.

The testing will include:
Test A - maximum arm cranking - 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. This data will be used to determine their arm cranking capacity and prescribe the workloads for the proceeding tests and training.
Test 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.
Test C - Hybrid FES exercise (arm crank & FES cycling). The final trial will involve the superimposed arm cranking trial (B) on 40min of FES leg cycling. In total this trial will comprised of 40min FES cycling and 16min of hybrid exercise where arm cranking and FES cycling will be performed simultaneously. 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 over the session until the peak muscle stimulation intensity that can be comfortably tolerated by the participant is reached.

Throughout test B and C, 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.

Intervention - Hybrid exercise involves simultaneous voluntary arm cranking (Monark881E Arm Ergometer) and FES cycling (iFESLCE), which has been modified to suit persons with multiple sclerosis. The duration of exercise for each session will be 40 minutes and 2 sessions will take place per week for a total of 12 weeks. The hybrid exercise training program will take place at the University of Sydney, at the FitAbility rehabilitation Gym.
As part of the FES cycling, participants will be set up to ensure maximum extension is 15 degrees knee flexion, to ensure hyperextension does not occur. FES will be progressively increased over the first 20 minutes until at their maximum tolerable intensity, as previously determined during the pre-testing, then sustained for the remaining 20 minutes. Participants will be instructed not to voluntarily cycle with their legs during this time.
The arm crank cadence will be set at 50rpm. Intensity will be determined by power output, at a target of 60% of maxPO. After a short warm up, intermittent arm cranking exercise will begin when the muscle stimulation reaches its maximum (e.g. at 20min). As a supplementary measure of work intensity, rate of perceived exertion (RPE) will be taken every 5 minutes with an aim to maintain a rating of 14 (“somewhat hard”) on the 15-point BORG scale. Due to arm paresis and fatigue associated with MS, continuous arm cranking would not be plausible. Thus, while the lower limb exercise performs continuous involuntary exercise, the upper limb with engage in interval training. Participants will alternate between 30 seconds of arm cranking and a 30 second rest period, while continuing to cycle. The on/off periods will be modified in future sessions depending on the arm cranking ability and tolerance of the individuals.
Intervention adherence will be assessed for this training program and is defined as performing 75% or more of the intervention as it was prescribed by frequency of days/week exercise and total duration of exercise in minutes/week. Where possible participants will be rescheduled if they are unable to attend a training session. Participants are able to withdraw from the trials or training program at any time.

FES cycling equipment -
Functional electrical stimulation will be performed on the iFES-LCE developed at the University of Sydney which has been specically 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 cycling will be at cadence of 10rpm.
Intervention code [1] 297514 0
Treatment: Devices
Intervention code [2] 297802 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301481 0
The peak oxygen consumption achieved during the arm cranking exercise trials. Measured by breath by breath analysis using a metabolic cart.
Timepoint [1] 301481 0
During Baseline, mid-training (6 weeks) and post exercise intervention (12 weeks) tests..
Primary outcome [2] 301790 0
The peak oxygen consumption achieved during the Hybrid exercise trials. Measured by breath by breath analysis using a metabolic cart.
Timepoint [2] 301790 0
During Baseline and post exercise intervention (12 weeks) tests..
Secondary outcome [1] 333869 0
Fatigue levels of the participant. Determined by the Fatigue Impact Scale questionnaire.
Timepoint [1] 333869 0
At baseline (0 weeks), mid-training (6 weeks), and post the exercise intervention (12 weeks).
Secondary outcome [2] 333878 0
Fatigue rated by the Participant on a Likert scale (0-10).
Timepoint [2] 333878 0
Before and after each exercise session throughout the training program
Secondary outcome [3] 333879 0
The Heart rate during the hybrid cycling exercise. Measured by polar heart rate monitor strap and watch.
Timepoint [3] 333879 0
During Baseline and post exercise intervention (12 weeks) tests.
Secondary outcome [4] 333880 0
The Heart rate during the arm cranking exercise. Measured by polar heart rate monitor strap and watch.
Timepoint [4] 333880 0
During Baseline, mid-training (6 weeks) and post exercise intervention (12 weeks) tests.

Eligibility
Key inclusion criteria
Diagnosis of advanced multiple sclerosis
EDSS 6.0-8.5 inclusive
Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting
Ability to perform arm cranking exercise (with at least one arm) without arm/shoulder pain.
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 they are unfit to exercise due to an absolute contraindication to exercise, have unstable cardiovascular disease or arrhythmia, high blood pressure, pressure ulcers, history of bone fracture, abnormal bone formation limiting range of motion, upper or lower body injury, pregnancy, and laxation of the shoulder joint.
Additionally participants will be excluded if their physician believes they cannot safely participate in this study due to other conditions.
People who have a serious cognitive impairment.
People who have had a multiple sclerosis exacerbation in the last three months.
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. patients who reacts very negatively to the experience or to the sensation of stimulation.
iii. patients with undiagnosed pain.
iv .patients who cannot provide adequate feedback concerning the level of stimulation


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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
The data will be analysed to estimate any changes in aerobic fitness and whether these are statistically significant. Descriptive statistics will be used to describe the maximum and average responses elicited from the pre and post-tests. Statistical analysis using paired t-tests will determine if the hybrid exercise intervention has significantly improved fitness and fatigue. The findings will be used to calculate effect sizes for a larger study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/05/2017
Actual
1/02/2018
Date of last participant enrolment
Anticipated
8/01/2020
Actual
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
10
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295906 0
University
Name [1] 295906 0
The University of Sydney
Country [1] 295906 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] 294780 0
None
Name [1] 294780 0
Address [1] 294780 0
Country [1] 294780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297187 0
Human Research Ethics Committee
Ethics committee address [1] 297187 0
THE UNIVERSITY OF SYDNEY
Level 2 Margaret Telfer Building (K07) The University of Sydney
NSW 2006
Ethics committee country [1] 297187 0
Australia
Date submitted for ethics approval [1] 297187 0
03/02/2017
Approval date [1] 297187 0
11/12/2017
Ethics approval number [1] 297187 0
2017/089

Summary
Brief summary
Aim: To determine if hybrid exercise can improve fitness in persons with advanced MS. The primary outcome measures are the peak oxygen consumption achieved during the arm cranking and hybrid exercise trials. Secondary outcome measures will include the participant fatigue (Likert scale) and Fatigue Impact Scale, heart rate (Polar monitor) during arm cranking and hybrid exercise, Cardiopulmonary measures will be taken before exercise, during each workload, and after exercise.

Intervention: Ten persons with advanced multiple sclerosis will undertake 12 weeks (2 days/weeks) of aerobic hybrid exercise training at the Faculty of Health Science, University of Sydney. Prior to commencement, 3 exercises tests will be conducted and repeated at the conclusion of the intervention. An incremental arm crank test will be conducted at the midpoint (6 weeks). The exercises tests include a maximum arm crank, incremental arm crank and hybrid FES cycling tests. Each test will be separated by between 2 days to a week. During the incremental arm crank and hybrid FES cycling test 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. Training involves two sessions a week of hybrid FES cycling (total session duration including setup and debrief will be 60min). Arm cranking will be at 30:30 second intervals at 60% of maxPO and continuous FES cycling at maximum tolerable intensity (increased to this point over the first 20 minutes). During training perceived exertion will be taken every 5 minutes to ensure the participant is working at a rating of 14 (“somewhat hard”) on the 15-point BORG scale.

Hypothesis: It is predicted the 12 weeks of hybrid FES cycling will be sufficient to illicit improvements in aerobic fitness. Therefore, the primary hypothesis tested is that hybrid FES exercise training will enhance the peak aerobic capacity elicited during arm crank exercise testing. Additional hypotheses will test other health related variables to determine if a program of Hybrid FES cycling has made any other impact on aerobic fitness and life in persons with advanced MS. The additional hypotheses are that: 1) Hybrid FES exercise training enhances the VO2Peak that can be produced during hybrid FES exercise testing and 2) Hybrid FES exercise training reduces the daily fatigue experienced (as measured by the fatigue impact scale [FIS]).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73270 0
Dr Che Fornusek
Address 73270 0
C103, Faculty of Health Science, University of Sydney 75 East Street Lidcombe, NSW 2141
Country 73270 0
Australia
Phone 73270 0
+61293519200
Fax 73270 0
+61293519204
Email 73270 0
[email protected]
Contact person for public queries
Name 73271 0
Che Fornusek
Address 73271 0
C103, Faculty of Health Science, University of Sydney 75 East Street Lidcombe, NSW 2141
Country 73271 0
Australia
Phone 73271 0
+61293519200
Fax 73271 0
+61293519204
Email 73271 0
[email protected]
Contact person for scientific queries
Name 73272 0
Che Fornusek
Address 73272 0
C103, Faculty of Health Science, University of Sydney 75 East Street Lidcombe, NSW 2141
Country 73272 0
Australia
Phone 73272 0
+61293519200
Fax 73272 0
+61293519204
Email 73272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No, IPD will not be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6496Ethical approval    372553-(Uploaded-08-06-2019-13-43-10)-Study-related document.pdf



Results publications and other study-related documents

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