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Trial registered on ANZCTR


Registration number
ACTRN12622001170718
Ethics application status
Approved
Date submitted
22/08/2022
Date registered
29/08/2022
Date last updated
29/08/2022
Date data sharing statement initially provided
29/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Multiple Sclerosis functional electrical stimulation cycling study
Scientific title
Cardiorespiratory response of functional electrical stimulation cycling versus voluntary cycling in people with moderate multiple sclerosis.
Secondary ID [1] 307777 0
None
Universal Trial Number (UTN)
U1111-1281-6061
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 327355 0
Condition category
Condition code
Neurological 324480 324480 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main purpose of the study will be to assess exercise capacity, cardiorespiratory and power outcomes on two modes of exercise during two different exercise protocols. The results will allow us to understand how to elicit higher intensities of exercise in people with moderate to advanced multiple sclerosis (MS).

Familiarization: Participants will perform six familiarization sessions with functional electrical simulation (FES) cycling and voluntary cycling). Electrical stimulation will be applied via gel electrodes on the front and back of the quadriceps, hamstring, and gluteal muscle groups to cause these muscles to contract and pedal the stationary cycle. Each familiarization session will be 1.5 hours in duration, including set up and exercise. These sessions will be performed prior to the exercise trials over a three to six week period and the final session will occur in the week before the first exercise trial. Stimulation amplitudes will initially be set at 20 mA or as tolerated by the participant and slowly increased over the first 10 minutes. The stimulation frequency will 35 Hz and pulse width 300 µs. Participants will then cycle voluntarily for 20 minutes with electrical stimulation at an RPE of 12 – 13. At a separate familiarization session, participants will also practice 20 minutes of voluntary cycling at an RPE of 12-13 without electrical stimulation.

For each exercise capacity test and exercise trial, the electrical stimulation will be increased over 10 minutes for the FES trials and will remain at 100% of the pre-determined maximum stimulation tolerated during familiarization. Each session will be supervised by an Exercise and Sports Science Australia Accredited Exercise Physiologist. Each trial will be separated by three days to one week.
Exercise capacity tests: Participants will perform two incremental exercise tests in a randomized order to determine peak VO2 and power. Exercise modes will include voluntary cycling and voluntary cycling combined with FES cycling.

Exercise trials: Participants will perform four exercise trials in a randomized order with cardiorespiratory measures (such as VO2, heart rate) and power as the main outcome measures. An average of the peak power data obtained in the voluntary cycling incremental test and voluntary combined FES cycling incremental test will be used to determine the percentage of peak arm crank Watts to be performed in trials.
1. FES cycling trial A: 10 mins of FES increase, then 20 minutes of FES cycling without any voluntary pedalling. FES at 100% tolerance
2. Voluntary cycling trial A: 20 minutes of voluntary cycling at 50% of peak cycling power (assessed in incremental test) at 12– 13 RPE
3. FES cycling trial B: 10 mins of FES increase, then 20 minutes of voluntary cycling in addition to FES. The power target will be 50% of peak cycling power plus the power generated in the FES cycling trial A at 13 – 14 RPE.
4. Voluntary cycling trial B: 20 minutes of voluntary cycling. The power target will be 50% of peak cycling power plus the power generated in the FES cycling trial A at 13 – 14 RPE.

Participants will be familiarized to FES cycling, voluntary cycling and RPE prior to the exercise trials. Participants will be instructed and encouraged to achieve target power and RPE outcomes during the exercise trials.
Intervention code [1] 324242 0
Lifestyle
Comparator / control treatment
Voluntary cycling. Cycling trials (2, 4) will serve as the comparator treatment.
Control group
Active

Outcomes
Primary outcome [1] 332314 0
Peak heart rate during each exercise trial. Measured by Polar OH1 optical heart rate monitor arm strap
Timepoint [1] 332314 0
Continuous measurement exercise capacity tests exercise trial 1 to 4.
Primary outcome [2] 332315 0
Peak oxygen consumption during each exercise trial. Measured by MGC Diagnostics Ultima Series metabolic cart
Timepoint [2] 332315 0
Continuous measurement during exercise capacity tests and exercise trials 1 - 4.
Secondary outcome [1] 412994 0
Voluntary cycling power output in Watts as recorded by the MOTOmed ergometer.
Timepoint [1] 412994 0
Continuous measurement during exercise capacity tests and exercise trials
Secondary outcome [2] 412995 0
FES cycling power output in Watts as recorded by the MOTOmed ergometer.
Timepoint [2] 412995 0
Continuous measurement during exercise capacity tests and exercise trials.
Secondary outcome [3] 412996 0
Feasibility: 7 Point Likert Scale
Timepoint [3] 412996 0
Participants will complete brief surveys to assess their perceptions. Participants will be asked how much they liked / disliked the exercise trial at the end of each trial.
Secondary outcome [4] 412997 0
Enjoyment: 7 Point Likert Scale
Timepoint [4] 412997 0
Participants will complete brief surveys to assess their perceptions. Participants will be asked how likely they might undertake the mode / intensity in an ongoing training program at the end of each trial.
Secondary outcome [5] 412998 0
Fatigue: 7 Point Likert Scale
Timepoint [5] 412998 0
Participants will be asked how fatigued they feel at the end of each trial (after 1 minute rest ad 5 minutes rest) and 24 hours after each trial. (7 point Likert scale).

Eligibility
Key inclusion criteria
Are aged between 18 and 70 years old
Have been given a diagnosis of multiple sclerosis with and EDSS of 4.0 to 6.5
Have not experienced an multiple sclerosis exacerbation in the past three months
Are medically stable and with no changes in medication used for MS in the past three months
Ability to perform voluntary cycling
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Absolute contraindications to exercise testing as defined by the American College of Sports Medicine, for example, unstable angina, uncontrolled cardiac arrhythmias, or severe heart failure.
Temporary contraindications may include uncontrolled hypertension, diabetes or recent heart attack, fracture, musculoskeletal injury or surgery, seizure or stroke, until stable.
Clinical evidence of any comorbid disease that may interfere with the ability to undertake the testing planned, including substance use disorder, psychosis, suicidality or significant cognitive impairment
Pregnant or are currently contemplating pregnancy
Contraindications to functional electrical stimulation such as cardiac demand pacemaker, or temporary exclusions until stable (e.g., healing fracture or chronic skin irritation)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The sequence in which each participant performs each trial will be individually randomized. There is no control group or intervention, therefore this is not a randomized controlled trial.
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
Statistical methods / analysis
The power calculations for this study are based on limited research comparing voluntary cycling with active FES cycling in people with MS and the exploratory nature of this study. Research involving people with advanced MS investigated differences in heart rate, VO2 and power whilst cycling voluntarily, cycling assisted by FES and FES cycling combined with voluntary cycling provides the basis for the effect size. This study compared the average heart rate between FES (79.1 ± 8.4) and FES cycling combined with voluntary cycling (84.7 ± 7.4) and showed an effect size of 0.95 when calculated using G*Power 3.1.9.4.

Heart rate has been chosen as the basis for the main hypothesis, and therefore power calculation, as it is readily measured in laboratory and clinical settings and can be used as an indicator of intensity during aerobic exercise. Moderate intensity exercise is required for gains in aerobic fitness.

On the basis of a power calculation an a of 0.05, a 1-ß of 0.80, and an effect size of 0.95 for one of the main outcome variables of detecting a difference in average HR between active FES cycling and voluntary cycling, 11 participants will be needed. We will aim to recruit 12 participants with an even spread in EDSS levels: four participants with EDSS 4.0 to 4.5, four participants with EDSS 5.0 to 5.5 and four participants with EDSS 6.0 and 6.5.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2022
Actual
Date of last participant enrolment
Anticipated
29/09/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312048 0
University
Name [1] 312048 0
The University of Sydney
Country [1] 312048 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
D18 - Susan Wakil Health Building
Western Avenue
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 313552 0
None
Name [1] 313552 0
Address [1] 313552 0
Country [1] 313552 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311461 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 311461 0
Ethics committee country [1] 311461 0
Australia
Date submitted for ethics approval [1] 311461 0
03/12/2020
Approval date [1] 311461 0
17/05/2021
Ethics approval number [1] 311461 0
2021/63

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121174 0
Dr Ché Fornusek
Address 121174 0
D18 - Susan Wakil Health Building
Western Avenue
The University of Sydney
NSW 2006
Country 121174 0
Australia
Phone 121174 0
+61 2 9351 9200
Fax 121174 0
Email 121174 0
che.fornusek@sydney.edu.au
Contact person for public queries
Name 121175 0
Ché Fornusek
Address 121175 0
D18 - Susan Wakil Health Building
Western Avenue
The University of Sydney
NSW 2006
Country 121175 0
Australia
Phone 121175 0
+61 2 9351 9200
Fax 121175 0
Email 121175 0
che.fornusek@sydney.edu.au
Contact person for scientific queries
Name 121176 0
Ché Fornusek
Address 121176 0
D18 - Susan Wakil Health Building
Western Avenue
The University of Sydney
NSW 2006
Country 121176 0
Australia
Phone 121176 0
+61 2 9351 9200
Fax 121176 0
Email 121176 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
Individual data will not be shared. Deidentified participant data will be aggregated and used in manuscripts for scientific journals.


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
No additional documents have been identified.