None listed
Conditions
Brief summary
This research seeks to improve the exercise options available to people with multiple sclerosis (MS). As MS worsens, the ability to perform aerobic exercise becomes difficult due to leg and/or arm paresis and the possible effects of MS related fatigue. The main purpose of the study will be to assess whether the technology of functional electrical stimulation can assist people with moderate MS to exercise at a higher intensity than they might otherwise be able to do. The results will increase the understanding around when voluntary cycling can be of benefit and when the addition of functional electrical stimulation might be beneficial in assisting persons with MS to exercise more effectively.
Interventions
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 appl
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.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
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)
Outcome results
None listed