Multiple Sclerosis, Chronic ProgressiveTIMENCT05562414
Transient and Immediate Motor Effects of Exercise in Progressive Multiple Sclerosis
A study testing HIIT and MCT in people with Multiple Sclerosis, Chronic Progressive and High-Intensity Interval Training, run by Klinik Valens at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Chronic Progressive, High-Intensity Interval Training, Motor Symptoms
- What is being tested?
- HIIT and MCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Klinik Valens, Valens rehabilitation clinic
Valens, Canton of St. Gallen, 7317
Jens Bansi, PhD, +41813031900, Jens.Bansi@kliniken-valens.ch
Roman Gonzenbach, MD, +41813031408, Roman.Gonzenbach@kliniken-valens.ch
About this study
Official title: 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.
Read more
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.
- Being tested
- HIIT, MCT
- Keywords
- Multiple Sclerosis, Chronic Progressive, Physical Conditioning, Human, Paraparesis, Gait, Dexterity
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Motor Activity, Paraparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITBehavioural
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.
MCTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity Interval Training (HIIT) | Experimental | Participants will complete one heart-rate-controlled HIIT bout within their 3-week inpatient stay. Receives: Behavioral: HIIT |
| Moderate Continuous Training (MCT) | Active comparator | MCT represents the standard treatment at Valens rehabilitation clinic. Participants will complete one heart-rate-controlled MCT bout within their 3-week inpatient stay. Receives: Behavioral: MCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional mobility
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.
Measured: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Secondary outcomes (4)
Spasticity (objective)
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.
Measured: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Spasticity (subjective)
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.
Measured: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Gait pattern
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.
Measured: Change from baseline to directly after, 1-hour after, 3-hours after and 5-hours after the exercise bout
Dexterity
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.
Measured: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Chronic ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre Randomized Controlled Trial (RCT)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Bansi, Klinik Valens
- Investigators
- Roman Gonzenbach, MD, Principal investigator, Kliniken Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562414
- Sponsor's protocol ID
- TIME
- Acronym
- TIME
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heine M, van de Port I, Rietberg MB, van Wegen EE, Kwakkel G. Exercise therapy for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2015 Sep 11;2015(9):CD009956. doi: 10.1002/14651858.CD009956.pub2.
PubMed 26358158Ensari I, Motl RW, Pilutti LA. Exercise training improves depressive symptoms in people with multiple sclerosis: results of a meta-analysis. J Psychosom Res. 2014 Jun;76(6):465-71. doi: 10.1016/j.jpsychores.2014.03.014. Epub 2014 Mar 31.
PubMed 24840141Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.
PubMed 23669008Taul-Madsen L, Connolly L, Dennett R, Freeman J, Dalgas U, Hvid LG. Is Aerobic or Resistance Training the Most Effective Exercise Modality for Improving Lower Extremity Physical Function and Perceived Fatigue in People With Multiple Sclerosis? A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2021 Oct;102(10):2032-2048. doi: 10.1016/j.apmr.2021.03.026. Epub 2021 Apr 24.
PubMed 33901439Ward M, Goldman MD. Epidemiology and Pathophysiology of Multiple Sclerosis. Continuum (Minneap Minn). 2022 Aug 1;28(4):988-1005. doi: 10.1212/CON.0000000000001136.
PubMed 35938654Bansi J, Koliamitra C, Bloch W, Joisten N, Schenk A, Watson M, Kool J, Langdon D, Dalgas U, Kesselring J, Zimmer P. Persons with secondary progressive and relapsing remitting multiple sclerosis reveal different responses of tryptophan metabolism to acute endurance exercise and training. J Neuroimmunol. 2018 Jan 15;314:101-105. doi: 10.1016/j.jneuroim.2017.12.001. Epub 2017 Dec 6.
PubMed 29224960
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient and Immediate Motor Effects of Exercise in Progressive Multiple Sclerosis: A Pilot Study.
- ClinicalTrials.gov ID
- NCT05562414
- Acronym / sponsor ID
- TIME / TIME
- Keywords
- Multiple Sclerosis, Chronic Progressive, Physical Conditioning, Human, Paraparesis, Gait, Dexterity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre Randomized Controlled Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| High-intensity Interval Training (HIIT) | Experimental | Behavioral: HIITParticipants will complete one heart-rate-controlled HIIT bout within their 3-week inpatient stay. |
| Moderate Continuous Training (MCT) | Active comparator | Behavioral: MCTMCT represents the standard treatment at Valens rehabilitation clinic. Participants will complete one heart-rate-controlled MCT bout within their 3-week inpatient stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIITExercise 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. | Behavioural | High-intensity Interval Training (HIIT) |
| MCTExercise 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. | Behavioural | Moderate Continuous Training (MCT) |
Primary outcome
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.
4 secondary outcomes
Spasticity (objective)
Time frame: 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
Gait pattern
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Background: PubMed 26358158Heine M, van de Port I, Rietberg MB, van Wegen EE, Kwakkel G. Exercise therapy for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2015 Sep 11;2015(9):CD009956. doi: 10.1002/14651858.CD009956.pub2.
- Background: PubMed 24840141Ensari I, Motl RW, Pilutti LA. Exercise training improves depressive symptoms in people with multiple sclerosis: results of a meta-analysis. J Psychosom Res. 2014 Jun;76(6):465-71. doi: 10.1016/j.jpsychores.2014.03.014. Epub 2014 Mar 31.
- Background: PubMed 23669008Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.
- Background: PubMed 33901439Taul-Madsen L, Connolly L, Dennett R, Freeman J, Dalgas U, Hvid LG. Is Aerobic or Resistance Training the Most Effective Exercise Modality for Improving Lower Extremity Physical Function and Perceived Fatigue in People With Multiple Sclerosis? A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2021 Oct;102(10):2032-2048. doi: 10.1016/j.apmr.2021.03.026. Epub 2021 Apr 24.
- Background: PubMed 35938654Ward M, Goldman MD. Epidemiology and Pathophysiology of Multiple Sclerosis. Continuum (Minneap Minn). 2022 Aug 1;28(4):988-1005. doi: 10.1212/CON.0000000000001136.
- Background: PubMed 29224960Bansi J, Koliamitra C, Bloch W, Joisten N, Schenk A, Watson M, Kool J, Langdon D, Dalgas U, Kesselring J, Zimmer P. Persons with secondary progressive and relapsing remitting multiple sclerosis reveal different responses of tryptophan metabolism to acute endurance exercise and training. J Neuroimmunol. 2018 Jan 15;314:101-105. doi: 10.1016/j.jneuroim.2017.12.001. Epub 2017 Dec 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Gonzenbach, MD principal investigator
Kliniken Valens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and MCT in people with Multiple Sclerosis, Chronic Progressive and High-Intensity Interval Training, run by Klinik Valens at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Bansi, PhD (+41813031403, jens.bansi@kliniken-valens.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional mobility (time frame: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562414, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.