Clinical trial NCT03949387: Functional Electrical Stimulation Cycling for Managing Mobility Disability in People with Multiple Sclerosis
Official title: Functional Electrical Stimulation Cycling for Managing Mobility Disability in People with Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: exercise
multiple sclerosis
mobility
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
name: Multiple Sclerosis Society of Canada
First posted: 2019-05-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The study is an assessor-blinded RCT for examining the efficacy and lasting effects of 24 weeks of supervised FES cycling exercise compared to passive leg cycling on mobility and secondary outcomes in people with MS with mobility impairment. Participants who meet the eligibility criteria will undergo the informed consent process and baseline assessment. Participants will then be randomized to either the FES or passive leg cycling program. Following baseline assessment, participants will complete a 24-week leg cycling program, with a mid-point assessment at 12 weeks. At 24 weeks, participants will undergo a post-intervention assessment. Following a 12-week follow-up period, participants will undergo a final assessment. Each participant will be involved in the study for approximately 10 months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Walking Speed
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Secondary outcomes:
measure: Change in Walking Endurance
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Agility
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Patient-rated Mobility Impairment
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Cognitive Performance: Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Cognitive Performance: Paced Auditory Serial Addition Test (PASAT)
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Fatigue Impact
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Fatigue Severity
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Pain
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Symptoms of Anxiety and Depression
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Health-related Quality of Life
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Activities of Daily Living
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Other outcomes:
measure: Change in Cardiorespiratory Fitness
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Muscular Fitness
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
measure: Change in Body Composition
timeFrame: Baseline and 24 weeks
measure: Change in Optical Coherence Tomography Measures
timeFrame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Lara Pilutti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.