Functional Electrical Stimulation Cycling for Managing Mobility Disability in People with Multiple Sclerosis

NCT03949387 | Completed

• 1 other identifier: OHSN-REB 20180731-01H
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Mobility impairment is one of the most common, poorly managed, and life altering consequences of MS. Current therapies for managing MS do not prevent the long-term accumulation of mobility impairment, highlighting the need for alternative strategies that prevent or slow progressive mobility disability. The proposed trial will test the efficacy and lasting effects of functional electrical stimulation (FES) cycling as an exercise-based rehabilitation strategy for managing mobility impairment and associated consequences in MS.

Conditions

Multiple Sclerosis

Keywords

exercise; multiple sclerosis; mobility

Outcome Measures

Primary Outcomes (1)

• Change in Walking Speed

  Walking speed will be assessed using the timed 25-foot walk (T25FW) test. Participants will walk as quickly and safely as possible across a 25-foot distance (2 trials; average reported in m/s).

  Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

Secondary Outcomes (11)

• Change in Walking Endurance

  Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

• Change in Agility

  Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

• Change in Patient-rated Mobility Impairment

  Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

• Change in Cognitive Performance: Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery

  Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

• Change in Cognitive Performance: Paced Auditory Serial Addition Test (PASAT)

  Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

Other Outcomes (4)

• Change in Cardiorespiratory Fitness

  Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

• Change in Muscular Fitness

  Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

• Change in Body Composition

  Baseline and 24 weeks

Study Arms (2)

FES Cycling Exercise

EXPERIMENTAL

FES cycling will involve systematic, transcutaneous electrical stimulation of the leg muscles to produce leg-cycling movement. The intensity and duration of training will be prescribed based on guidelines for aerobic exercise training for persons with MS and from the American College of Sports Medicine, and will progressively increase across 24 weeks. Participants will be encouraged to actively cycle at a minimum cadence of \~40-50 rpm, at 40-60% VO2peak for between 10-50 minutes. The intensity of stimulation will be adjusted per leg muscle group based on sensory tolerance with the goal of maintaining pedaling action and target heart rate over the entire session. At each session, we will record the distance traveled, energy expended, power output, resistance, heart rate and rating of perceived exertion (RPE).

Other: FES Cycling Exercise

Passive Leg Cycling

PLACEBO COMPARATOR

Passive leg cycling will involve movement of the participant's legs by the cycle ergometer motor without electrical stimulation. The duration of training will follow the same schedule as the FES cycling condition and the same data will be recorded at each session. The passive cycling condition will include the same exposure with the training facility, the exercise equipment (i.e. RT300 cycles), and the research staff (i.e. social contact and attention) as with the FES cycling condition.

Other: Passive Leg Cycling

Interventions

FES Cycling Exercise OTHER

FES cycling will use self-adhering surface electrodes (Pals Platinum, Fallbrook, CA) placed over the quadriceps, hamstrings, and gluteal muscle groups to deliver stimulation to the leg muscles.

FES Cycling Exercise

Passive Leg Cycling OTHER

Passive leg cycling will not involve electrical stimulation

Passive Leg Cycling

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of multiple sclerosis
• relapse free in the past 30 days
• stable course of disease-modifying therapies over the past 6 months
• ability to communicate in English
• willing to come to the University of Ottawa to complete testing and training sessions
• EDSS score 5.0 - 7.0
• asymptomatic based on a physical activity pre-participation screening tool

You may not qualify if:

• presence of any contraindication to FES including epilepsy, a pacemaker, implanted defibrillator, unstable fracture, or pregnancy
• diagnosis of other neurological condition(s)
• participation in FES cycling exercise or other mobility-based exercise rehabilitation program within the past 6 months
• current use of dalfampridine within the past month

Sponsors & Collaborators

• University of Ottawa: lead
• The Ottawa Hospital: collaborator
• Multiple Sclerosis Society of Canada: collaborator

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Related Publications (3)

• Edwards T, Motl RW, Pilutti LA. Cardiorespiratory demand of acute voluntary cycling with functional electrical stimulation in individuals with multiple sclerosis with severe mobility impairment. Appl Physiol Nutr Metab. 2018 Jan;43(1):71-76. doi: 10.1139/apnm-2017-0397. Epub 2017 Sep 7.

  PMID: 28881147 BACKGROUND

• Pilutti LA, Motl RW, Edwards TA, Wilund KR. Rationale and design of a randomized controlled clinical trial of functional electrical stimulation cycling in persons with severe multiple sclerosis. Contemp Clin Trials Commun. 2016 May 15;3:147-152. doi: 10.1016/j.conctc.2016.05.005. eCollection 2016 Aug 15.

  PMID: 29736463 BACKGROUND

• Edwards T, Motl RW, Sebastiao E, Pilutti LA. Pilot randomized controlled trial of functional electrical stimulation cycling exercise in people with multiple sclerosis with mobility disability. Mult Scler Relat Disord. 2018 Nov;26:103-111. doi: 10.1016/j.msard.2018.08.020. Epub 2018 Sep 8.

  PMID: 30243234 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Lara Pilutti, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be collected objectively by researchers who are blinded to treatment allocation. Researchers who are involved with delivery of the intervention will be aware of treatment allocation, but will not be involved with data collection, entry or analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study will use a two-arm, parallel group, single-blinded placebo-controlled RCT design that examines the efficacy and lasting effects of 24-weeks of FES cycling exercise compared to passive leg cycling in persons with MS with mobility impairment.

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 14, 2019
• Study Start: October 16, 2019
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)