Transient and Immediate Motor Effects of Exercise in Progressive Multiple Sclerosis (TIME)

October 12, 2022 updated by: Jens Bansi, Klinik Valens

Transient and Immediate Motor Effects of Exercise in Progressive Multiple Sclerosis: A Pilot Study.

Endurance training is a cornerstone of rehabilitation in Multiple Sclerosis (MS) due to its beneficial effects on multiple MS-related symptoms, such as health-related quality of life, aerobic capacity (VO2peak), functional mobility, gait, depressive symptoms, and fatigue.

Persons with progressive phenotypes of MS, namely primary progressive MS (PPMS) and secondary progressive (SPMS), represent a minor proportion of the total MS population, thus having been underrepresented in previous studies. The generalizability of existing evidence may be compromised by differences in symptom expression between MS phenotypes, with a dominance of motor symptoms (i.e., paraspasticity and/or paraparesis) in PPMS and SPMS.

Adding up to this, clinical experiences of neurologists and sports scientists reveal that the effects of endurance exercise are characterized by a distinct time course, firstly inducing a minor and transient deterioration of motor symptoms that is followed by motor symptom alleviation beyond baseline level. This phenomenon was mainly related to the performance of High-Intensity Interval training (HIIT), but not to moderate-intensity continuous training (MCT).

Therefore, this pilot study aims to systematically investigate the time course of acute motor effects on spasticity, functional mobility, gait, and dexterity in persons with PPMS and SPMS following two different endurance training protocols, that are HIIT and MCT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Sankt Gallen
      • Valens, Sankt Gallen, Switzerland, 7317
        • Recruiting
        • Klinik Valens, Valens rehabilitation clinic
        • Contact:
        • Sub-Investigator:
          • Marie Kupjetz, cand. PhD
        • Contact:
        • Sub-Investigator:
          • Ramona Sylvester, MSc.
        • Sub-Investigator:
          • Isa Slotboom, MSc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult age (≥ 18 years)
  • definite MS diagnosis according the 2017 revised McDonald criteria
  • PPMS/SPMS phenotype according to the 2013 revised Lublin criteria
  • Expanded Disability Status Scale (EDSS) score ≤ 6.0
  • Informed Consent as documented by signature of participants and PI

Exclusion Criteria:

  • severe lower extremity spasticity or severe concomitant disease states (i.e., orthopaedic, cardiovascular, metabolic, psychiatric (e.g., substance abuse), other neurological, other serious medical conditions) impairing the ability to participate
  • inability to follow study procedures (e.g., due to language barriers)
  • suspected non-compliance
  • previous enrolment into the current study
  • enrolment of the investigator, his/her family members, employees, and other dependent persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High-intensity Interval Training (HIIT)
Participants will complete one heart-rate-controlled HIIT bout within their 3-week inpatient stay.
Behavioral: HIIT

Exercise intensity will be regulated and heart rate controlled based on the age-predicted heart rate (HRmax), as calculated by the formula 220 minus age in years.

Participants will perform six high-intensity intervals (95% HRmax) at high pedalling rates of 80-100 rounds per minute (rpm) for 60-90 seconds each. Intervals are interspersed by active breaks of unloaded pedalling (20 watts, 60-80rpm) aimed to return to 60% HRmax (approximately 1.5-2 min). The duration of the HIIT bout is approximately 21 minutes.
ACTIVE_COMPARATOR: Moderate Continuous Training (MCT)
MCT represents the standard treatment at Valens rehabilitation clinic. Participants will complete one heart-rate-controlled MCT bout within their 3-week inpatient stay.
Behavioral: MCT

Exercise intensity will be regulated and heart rate controlled based on the age-predicted heart rate (HRmax), as calculated by the formula 220 minus age in years.

Participants will continuously train at 60% HRmax and pedal at 60-80 rounds per minute. The duration of the MCT bout is 26 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional mobility
Time Frame: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Functional mobility is assessed by the Timed-Up-and-Go Test (TUG). For the TUG, participants are asked to get up from a chair, walk a 3 metres distance, perform a 180° turn, return to the chair, and sit down again as fast as possible. Assessment takes place on a single day, before (T0), 5 minutes after (T1), 60 minutes after (T2), 180 minutes after (T3), 300 minutes (T4) after HIIT/MCT cycling bout.
Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spasticity (objective)
Time Frame: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Spasticity of the hip flexors, knee flexors, foot dorsiflexors and respective extensors will be evaluated using the Modified Ashworth Scale (MAS). The participant is placed on a bench in supine position. The outcome assessor performs a passive stretch on the respective muscle group and scores the muscle tone as normal or increased on a 6-category ordinal scale (0, 1, 1+, 2, 3, 4). Assessment takes place on a single day, before (T0), 5 minutes after (T1), 60 minutes after (T2), 180 minutes after (T3), 300 minutes (T4) after HIIT/MCT cycling bout.
Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Spasticity (subjective)
Time Frame: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Participants rate the extent of perceived spasticity on a Numeric Rating Scale for Spasticity (NRS-S), ranging from 0 ("no spasticity") to 10 ("worst possible spasticity"). Assessment takes place on a single day, before (T0), 5 minutes after (T1), 60 minutes after (T2), 180 minutes after (T3), 300 minutes (T4) after HIIT/MCT cycling bout.
Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Gait pattern
Time Frame: Change from baseline to directly after, 1-hour after, 3-hours after and 5-hours after the exercise bout
Spatiotemporal features of the gait pattern analysis are captured by the instrumented treadmill C-Mill for a duration of two minutes. Assessment takes place on a single day, before (T0), 5 minutes after (T1), 60 minutes after (T2), 180 minutes after (T3), 300 minutes (T4) after HIIT/MCT cycling bout.
Change from baseline to directly after, 1-hour after, 3-hours after and 5-hours after the exercise bout
Dexterity
Time Frame: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Dexterity is assessed by the Virtual Peg Insertion Test (VPIT). The VPIT is a virtual instrumented 3D object manipulation (pick-and-place) task. In seated position, participants are asked to transport virtual pegs into virtual holes as fast as possible. Participants perform four trials with their dominant hand. Spatiotemporal movement trajectories are recorded. Assessment takes place on a single day, before (T0), 5 minutes after (T1), 60 minutes after (T2), 180 minutes after (T3), 300 minutes (T4) after HIIT/MCT cycling bout.
Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinik Valens

Investigators

  • Principal Investigator: Roman Gonzenbach, MD, Kliniken Valens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2022

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (ACTUAL)

September 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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