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Exploring the potential of Hybrid Electrical Stimulation Cycling for aerobic exercise in Persons with Advanced Multiple Sclerosis

Effect of hybrid functional electrical stimulation cycling on aerobic exercise response in persons with advanced multiple sclerosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000415303
Enrollment
8
Registered
2017-03-23
Start date
2018-02-01
Completion date
2019-08-01
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

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.

Sponsors

Dr Che Fornusek
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026