The Therapeutic Effects of Forced Aerobic Exercise in Multiple Sclerosis

NCT04906057 | Completed Results

• 1 other identifier: 19-1003
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

This project will investigate the feasibility and initial efficacy of two aerobic exercise training approaches, forced and voluntary, to improve motor function in persons with multiple sclerosis (MS). We hypothesize that intensive aerobic exercise training elicits a neurorepairative and neurorestorative response on the central nervous system, which may improve motor function as it relates to gait and mobility. Should aerobic cycling, forced or voluntary, improve gait and functional mobility in persons with MS, it would serve as a new model to restoring function, rather than current models that focus on compensation.

Conditions

Multiple Sclerosis

Keywords

aerobic exercise; gait

Outcome Measures

Primary Outcomes (9)

• Exercise Duration

  Average exercise duration

  collected during each exercise session (twice per week for 12 weeks)

• Aerobic Intensity

  average percent max heart rate

  Collected during each exercise session (twice per week for 12 weeks)

• Exercise Cadence

  Average Exercise Cadence (cycling rate)

  collected during each exercise session (twice per week for 12 weeks)

• Six Minute Walk Test

  The distance walked over 6 minutes is measured on an oval walking track

  Week 0 (baseline), Week 13 (post exercise sessions)

• Gait Velocity

  Spatio-temporal and kinematic parameters of gait will be obtained using 3-D motion capture and an instrumented walkway.

  Week 0 (baseline), Week 13 (post exercise sessions)

• PROMIS-29

  The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in the general population and with individuals living with chronic conditions. Raw scores were converted to T-scores (using an adult referent population) ranging from 0-100 with a mean of 50 and standard deviation (SD) of 10 in the referent population. For the PROMIS-29 symptom-related domains (anxiety, depression, fatigue, sleep disturbance, and pain interference), higher scores represent greater symptom burden (worse function). For the physical and participation domains, higher scores represent greater levels of function. Pain intensity is scored separately using a 0-10 scaler with higher scores representing greater pain.

  Week 0 (baseline), Week 13 (post exercise sessions)

• Modified Fatigue Impact Scale (MFIS)

  The MFIS is a 21-item self-reported measure of how fatigue impacts the lives of persons with multiple sclerosis. This instrument provides an assessment of the effects of fatigue as it relates to physical, cognitive, and psychosocial functioning. Participants rate on a 5-point Likert scale, with 0 = 'Never' to 4 = 'Almost always' their agreement with 21 statements. Total score (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8). Higher numbers indicate greater fatigue in all domains.

  Week 0 (baseline), Week 13 (post exercise sessions)

• Multiple Sclerosis Manual Dexterity Test

  Assessment examining cognitive and hand function for persons with MS

  Week 0 (baseline), Week 13 (post exercise sessions)

• Processing Speed Test

  Assessment examining processing speed using an tablet-based measure developed to closely resemble the symbol digit modalities test. Participants match symbols to digits over a 2-minute trial. The number of correct matches represents the score, with higher correct matches indicative of better processing speed performance. The low range of possible scoring is 0 with no upper range limit. In a study by Rao and colleagues (2017), persons with MS scored and average of 51.1 (+/- 11.9) on the first trial and 52.8 (+/- 2.0) on the second trial. One trial was conducted in this study.

  Week 0 (baseline), Week 13 (post exercise sessions)

Secondary Outcomes (1)

• To Investigate the Role of Klotho in Promoting Neuroprotection.

  Week 1 (exercise session 1), Week 12 (exercise session 24)

Study Arms (2)

Forced Aerobic Exercise (FE)

EXPERIMENTAL

The FE group (N=10) will complete 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's). The VE group (N=10) will exercise on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance.

Behavioral: Forced Aerobic Exercise (FE)

Voluntary Aerobic Exercise (VE)

ACTIVE COMPARATOR

The VE group (N=10) will exercise on an identical semi-recumbent cycle ergometer for 45 minutes at their self-selected cadence without assistance.

Behavioral: Voluntary Aerobic Exercise (VE)

Interventions

Forced Aerobic Exercise (FE) BEHAVIORAL

High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer

Forced Aerobic Exercise (FE)

Voluntary Aerobic Exercise (VE) BEHAVIORAL

Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer

Voluntary Aerobic Exercise (VE)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Participants identifying as male or female are eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of RRMS with Expanded Disability Status Scale (EDSS) score between 1.5 and 6.5,
• years of age,
• Deemed minimal risk for cardiovascular event using American College of Sports Medicine Exercise Pre-participation Criteria

You may not qualify if:

• hospitalization for myocardial infarction, heart failure or heart surgery within 3 months,
• serious cardiac arrhythmia,
• hypertrophic cardiomyopathy,
• severe aortic stenosis,
• pulmonary embolus,
• significant contractures,
• dysphagia resulting in inability to sufficiently hydrate, and
• other contraindication to exercise.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Donayja Harris
• Organization: Cleveland Clinic

harrisD47@ccf.org

2164454125

Study Officials

• Susan M Linder, DPT

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Group allocation will be concealed to the individual obtaining all outcomes of interest
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Staff, Physical Medicine and Rehabilitation

Model Details: rater-blind, prospective randomized trial

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 28, 2021
• Study Start: July 6, 2021
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: March 6, 2025
• Results First Posted: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)