Primary Progressive Multiple SclerosisCYPRONCT05229861
The Influence of HIIT Versus MCT on Cardiorespiratory Fitness in PPMS
A study testing HIIT and MCT in people with Primary Progressive Multiple Sclerosis and Exercise, run by Klinik Valens at 1 site in Switzerland.
Trial summary
Endurance training revealed to be an effective means to increase cardiorespiratory fitness in persons with Multiple Sclerosis (MS), considered relevant to health-related quality of life in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Progressive Multiple Sclerosis, Exercise, Cardiorespiratory Fitness
- 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
- 61 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 May 2022to 29 Feb 2024
- 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
- disease course: PPMS according to the 2013 revised Lublin criteria
- disease severity: Expanded Disability Status Scale (EDSS) score ≤ 6.0
- Informed Consent as documented by signature of participants and PI
Who cannot join
- Persons suffering from 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 their ability to participate.
- Persons regularly performing HIIT (2-3 times per week)
- Inability to follow the procedures of the study due to language problems (i.e., participant not fluent in oral and written German language)
- Changes in disease-modifying drugs (≤ 6 weeks)
- Immunosuppressive therapy (i.e., corticosteroids) (≤ 4 weeks)
- Stem cell treatment (≤ 6 months)
Show all 13Show fewer
- Pregnant or breast-feeding women
- Intention to become pregnant during the course of the study
- Suspected non-compliance
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees, and other dependent persons
- occurrence of severe pulmonary or cardiovascular decompensations (i.e., blood pressure (Riva Rocci) > 240/120, HR ≥ HRmax (220-years of age) (e.g. due to renal failure, hepatic dysfunction, cardiovascular disease)
- abnormalities in electrocardiography (ECG), pulse oximetry, or spirometry during initial CPET
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
Jens Bansi, PhD
About this study
Official title: The Influence of High-Intensity Interval Training Compared to Moderate Continuous Training on Cardiorespiratory Fitness, Symptom Improvement, and Disease-specific Biomarkers in Primary Progressive Multiple Sclerosis
Endurance training revealed to be an effective means to increase cardiorespiratory fitness in persons with Multiple Sclerosis (MS), considered relevant to health-related quality of life in this population. Moreover, endurance training improves MS-related symptoms, such as reduced walking capacity, fatigue, depression, and cognitive impairment. Owing to these benefits, endurance training has evolved as an integral part of MS rehabilitation, anchored in current treatment guidelines.
In recent years, High-Intensity Interval training (HIIT) evolved as a time-efficient and safe alternative to standard care in MS rehabilitation that is Moderate Continuous Training (MCT). Indeed, HIIT has already been proven superior to MCT in improving cardiorespiratory fitness, MS-related symptoms (e.g. cognitive impairment) and, beyond, seems to elicit disease-modifying effects on MS-pathophysiology (i.e. alleviated neuroinflammation and neurodegeneration).
Read more
However, current evidence is restricted to clinical trials that include samples with mixed MS disease courses, in which persons with primary progressive MS (PPMS) are underrepresented due to comparatively low prevalence rates.
Distinct pathophysiological mechanisms and symptom constellations prohibit the generalisation of previous findings to persons with PPMS. In this population, however, evidence-based rehabilitative strategies are urgently needed, as disability progression in PPMS is poorly responsive to pharmacotherapy.
This study, aims to validate previous findings on the superior effect of HIIT compared to MCT on improving cardiorespiratory fitness, MS-related symptoms and MS pathophysiology in persons with PPMS, contributing to the development of specific recommendations to maximize the effects of exercise as a potent non-pharmacological treatment adjuvant.
- Being tested
- HIIT, MCT
- Keywords
- Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Exercise, High-intensity Interval Exercise, Rehabilitation, Cardiorespiratory Fitness, Cognition, Mobility limitation, Quality of Life, Fatigue, Depression, Immune signalling, Inflammation, Kynurenine pathway
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Motor Activity, Multiple Sclerosis, Mobility Limitation, Fatigue, Depression, Inflammation
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 achieved maximum heart rate (HRmax) assessed during the initial Cardiopulmonary Exercise Testing. Participants will perform five high-intensity intervals (95% HRpeak) at high pedalling rates of 80-100 rpm for 90 seconds each. Intervals are interspersed by active breaks of unloaded pedalling (20W, 60-70rpm) aimed to return to 60% HRpeak (approximately 1-1.5 min). The duration of a HIIT sessions is approximately 25 minutes.
MCTBehavioural
Exercise intensity will be regulated and heart rate controlled based on the achieved maximum heart rate (HRmax) assessed during the initial Cardiopulmonary Exercise Testing. Participants perform continuous bicycle ergometry at moderate intensity (60% HRpeak) and 60-70 rpm for the duration of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity Interval Training (HIIT) | Experimental | Participants will complete seven HR-controlled HIIT sessions within their 3-week inpatient stay, corresponding to 3 exercise bouts per week. Receives: Behavioral: HIIT |
| Moderate Continuous Training (MCT) | Active comparator | MCT represents the standard treatment at Valens rehabilitation clinic. Participants will complete seven HR-controlled MCT sessions within their 3-week inpatient stay, corresponding to 3 exercise bouts per week. Receives: Behavioral: MCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness (peak oxygen consumption, VO2peak)
Cardiorespiratory fitness will be measured by peak oxygen consumption achieved in the cardiopulmonary exercise test (CPET). Higher values indicate better cardiorespiratory fitness.
Measured: Three weeks (day 0 to day 21)
Secondary outcomes (10)
Peak power output (PPO)
PPO is assessed during CPET and represents the maximum wattage achieved until exhaustion. Higher values reflect higher PPO.
Measured: Three weeks (day 0 to day 21)
Cognitive performance
Cognitive performance is assessed with the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS). This test battery involves three tests to assess the main cognitive domains vulnerable to MS: information processing speed, verbal and visual memory. The battery includes the Symbol Digit modalities Test (SDMT), Californian Verbal Learning Test-II (CVLT-II) and the Brief Visuospatial Memory Test revised (BVMT-R). Processing speed is the most relevant test and is assessed by the SDMT where the patients have 90s to voice numbers as rapidly as possible that were associated with target symbols within a grid printed at the top of a Stimulus page. The final score is the correct number of substitutions in 90 s, and scores ranges between 0 and 110. Higher scores indicating better cognition.
Measured: Three weeks (day 0 to day 21)
Cognitive impairment at baseline
Screening of cognitive impairment is performed using the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point paper-pencil test that can be easily completed within 10 minutes. Items of the MoCA query short-term memory recall, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place, all of which are summed up to a total score. A MoCa total score of < 26 is a sensitive measure of cognitive impairment in otherwise healthy subjects and in persons with MS.
Measured: Baseline (day 0)
Walking capacity
Walking capacity is assessed via the six-minute walk test (6-MWT). The 6-MWT is used to determine the total distance in meters covered within six minutes when walking back and forth on a 30 metres hallway, as a measure of endurance walking capacity. Longer distance covered in metres reflects higher walking capacity.
Measured: Three weeks (day 0 to day 21)
Physical and psychological Impairment
Physical and psychological Impairment is queried using the Multiple Sclerosis Impact Scale-29 (MSIS-29).The MSIS-29 contains a total of 29 items, split into two subscales, that adress physical impairment (20 items) and psychological impairment (9 items). Each item is ranked on a 5-point Likert scale with higher scores indicating higher physical and psychological impairment.
Measured: Three weeks (day 0 to day 21)
Fatigue
Fatigue is assessed by means of the Fatigue Motor and Cognitive Scale (FSMC), that allows separate rating of motor and cognitive fatigue, based on a 5-point Likert scale (range 1-5). Scores range from 20-100 for the total, and from 10-50 for each subscale. Higher scores indicate a higher level of fatigue.
Measured: Three weeks (day 0 to day 21)
Anxiety and depressive symptoms
Anxiety and depressive symptoms are assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS was created as a 14-item scale for adults with physical ailments. On a 4-point Likert scale (range 0-3), patients rate anxiety (7 items) and depressive symptoms (7 items), respectively. Higher scores indicate a higher level of anxiety or depressive symptoms.
Measured: Three weeks (day 0 to day 21)
Kynurenine pathway (KP) metabolites
Changes in KP metabolites are assessed to investigate the biological mechanisms that may underpin clinical improvement in persons with PPMS. The KP is dysregulated in persons with MS and is sensitive to exercise-related changes.
KP metabolites include tryptophan, kynurenine, kynurenic acid, quinolinic acid, indolamine 2,3-dioxygenase, and tryptophan 2,3-dioxygenase. Higher levels of kynurenic acid and tryptophan, and lower levels of kynurenine, kynurenic acid, quinolinic acid, indolamine 2,3-dioxygenase, and tryptophan 2,3-dioxygenase indicate a beneficial effect of KP regulation.
KP metabolites are analyzed via targeted metabolomics (HPLC MS/MS).
Measured: Three weeks (day 0 to day 21)
Immune status (blood cells)
Numbers and proportions of circulating immune cells associated with MS and exercise (Th17 cell, cytotoxic T-cells, naïve T-cells, memory T-cells, NK-cells, Monocytes) are assessed, with higher values indicating higher levels of inflammation. Number and proportion of circulating regulatory T cells with higher values indicating lower levels of inflammation.
Numbers of proportions of these circulating immune cells are determined by flow cytometric characterization of Th17 cell, cytotoxic T-cells, naïve T-cells, memory T-cells, NK-cells, and Monocytes.
Measured: Time Frame: Three weeks (day 0 to day 21)
Immune status (pro-inflammatory cytokines)
The pro-inflammatory cytokines IL-6, IFN-γ, TNF-α are known to be produced or secreted in response to chronic exercise and modify immune homeostasis. Higher values indicate higher levels of inflammation.
Serum concentrations of IL-6, IFN-γ, and TNF-α are determined using commercial enzyme-linked immunosorbent assays (ELISAs) according to the manufacturer's instructions.
Measured: Time Frame: Three weeks (day 0 to day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start10 May 2022
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Primary Progressive Multiple SclerosisStudies 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
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dortmund, Germany
- Responsible party
- Principal investigator, Jens Bansi, Klinik Valens
- Investigators
- Roman Gonzenbach, MD, Study director, Klinik ValensBansi Jens, PhD, Principal investigator, Klinik Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229861
- Sponsor's protocol ID
- CYPRO
- Acronym
- CYPRO
- Status last verified
- Jun 2022
- First submitted
- 14 Jan 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bansi 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 29224960Zimmer P, Bloch W, Schenk A, Oberste M, Riedel S, Kool J, Langdon D, Dalgas U, Kesselring J, Bansi J. High-intensity interval exercise improves cognitive performance and reduces matrix metalloproteinases-2 serum levels in persons with multiple sclerosis: A randomized controlled trial. Mult Scler. 2018 Oct;24(12):1635-1644. doi: 10.1177/1352458517728342. Epub 2017 Aug 21.
PubMed 28825348Joisten N, Proschinger S, Rademacher A, Schenk A, Bloch W, Warnke C, Gonzenbach R, Kool J, Bansi J, Zimmer P. High-intensity interval training reduces neutrophil-to-lymphocyte ratio in persons with multiple sclerosis during inpatient rehabilitation. Mult Scler. 2021 Jun;27(7):1136-1139. doi: 10.1177/1352458520951382. Epub 2020 Sep 3.
PubMed 32880214Joisten N, Rademacher A, Warnke C, Proschinger S, Schenk A, Walzik D, Knoop A, Thevis M, Steffen F, Bittner S, Gonzenbach R, Kool J, Bloch W, Bansi J, Zimmer P. Exercise Diminishes Plasma Neurofilament Light Chain and Reroutes the Kynurenine Pathway in Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2021 Mar 29;8(3):e982. doi: 10.1212/NXI.0000000000000982. Print 2021 May.
PubMed 33782190Lea Schlagheck M, Wucherer A, Rademacher A, Joisten N, Proschinger S, Walzik D, Bloch W, Kool J, Gonzenbach R, Bansi J, Zimmer P. VO2peak Response Heterogeneity in Persons with Multiple Sclerosis: To HIIT or Not to HIIT? Int J Sports Med. 2021 Dec;42(14):1319-1328. doi: 10.1055/a-1481-8639. Epub 2021 Jul 1.
PubMed 34198345Rademacher A, Joisten N, Proschinger S, Hebchen J, Schlagheck ML, Bloch W, Gonzenbach R, Kool J, Bansi J, Zimmer P. Do baseline cognitive status, participant specific characteristics and EDSS impact changes of cognitive performance following aerobic exercise intervention in multiple sclerosis? Mult Scler Relat Disord. 2021 Jun;51:102905. doi: 10.1016/j.msard.2021.102905. Epub 2021 Mar 18.
PubMed 33836459Rademacher A, Joisten N, Proschinger S, Bloch W, Gonzenbach R, Kool J, Langdon D, Bansi J, Zimmer P. Cognitive Impairment Impacts Exercise Effects on Cognition in Multiple Sclerosis. Front Neurol. 2021 Jan 28;11:619500. doi: 10.3389/fneur.2020.619500. eCollection 2020.
PubMed 33633658Kupjetz M, Joisten N, Rademacher A, Gonzenbach R, Bansi J, Zimmer P. Cycling in primary progressive multiple sclerosis (CYPRO): study protocol for a randomized controlled superiority trial evaluating the effects of high-intensity interval training in persons with primary progressive multiple sclerosis. BMC Neurol. 2023 Apr 22;23(1):162. doi: 10.1186/s12883-023-03187-6.
PubMed 37087424
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of High-Intensity Interval Training Compared to Moderate Continuous Training on Cardiorespiratory Fitness, Symptom Improvement, and Disease-specific Biomarkers in Primary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05229861
- Acronym / sponsor ID
- CYPRO / CYPRO
- Keywords
- Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Exercise, High-intensity Interval Exercise, Rehabilitation, Cardiorespiratory Fitness, Cognition, Mobility limitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Collaborators
- Technische Universität Dortmund, Germany
- Study start
- 10 May 2022 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 8 Feb 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 revealed to be an effective means to increase cardiorespiratory fitness in persons with Multiple Sclerosis (MS), considered relevant to health-related quality of life in this population. Moreover, endurance training improves MS-related symptoms, such as reduced walking capacity, fatigue, depression, and cognitive impairment. Owing to these benefits, endurance training has evolved as an integral part of MS rehabilitation, anchored in current treatment guidelines.
In recent years, High-Intensity Interval training (HIIT) evolved as a time-efficient and safe alternative to standard care in MS rehabilitation that is Moderate Continuous Training (MCT). Indeed, HIIT has already been proven superior to MCT in improving cardiorespiratory fitness, MS-related symptoms (e.g. cognitive impairment) and, beyond, seems to elicit disease-modifying effects on MS-pathophysiology (i.e. alleviated neuroinflammation and neurodegeneration).
However, current evidence is restricted to clinical trials that include samples with mixed MS disease courses, in which persons with primary progressive MS (PPMS) are underrepresented due to comparatively low prevalence rates.
Distinct pathophysiological mechanisms and symptom constellations prohibit the generalisation of previous findings to persons with PPMS. In this population, however, evidence-based rehabilitative strategies are urgently needed, as disability progression in PPMS is poorly responsive to pharmacotherapy.
This study, aims to validate previous findings on the superior effect of HIIT compared to MCT on improving cardiorespiratory fitness, MS-related symptoms and MS pathophysiology in persons with PPMS, contributing to the development of specific recommendations to maximize the effects of exercise as a potent non-pharmacological treatment adjuvant.
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 seven HR-controlled HIIT sessions within their 3-week inpatient stay, corresponding to 3 exercise bouts per week. |
| Moderate Continuous Training (MCT) | Active comparator | Behavioral: MCTMCT represents the standard treatment at Valens rehabilitation clinic. Participants will complete seven HR-controlled MCT sessions within their 3-week inpatient stay, corresponding to 3 exercise bouts per week. |
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
- disease course: PPMS according to the 2013 revised Lublin criteria
- disease severity: Expanded Disability Status Scale (EDSS) score ≤ 6.0
- Informed Consent as documented by signature of participants and PI
Key exclusion criteria (13 listed)
- Persons suffering from 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 their ability to participate.
- Persons regularly performing HIIT (2-3 times per week)
- Inability to follow the procedures of the study due to language problems (i.e., participant not fluent in oral and written German language)
- Changes in disease-modifying drugs (≤ 6 weeks)
- Immunosuppressive therapy (i.e., corticosteroids) (≤ 4 weeks)
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 achieved maximum heart rate (HRmax) assessed during the initial Cardiopulmonary Exercise Testing. Participants will perform five high-intensity intervals (95% HRpeak) at high pedalling rates of 80-100 rpm for 90 seconds each. Intervals are interspersed by active breaks of unloaded pedalling (20W, 60-70rpm) aimed to return to 60% HRpeak (approximately 1-1.5 min). The duration of a HIIT sessions is approximately 25 minutes. | Behavioural | High-intensity Interval Training (HIIT) |
| MCTExercise intensity will be regulated and heart rate controlled based on the achieved maximum heart rate (HRmax) assessed during the initial Cardiopulmonary Exercise Testing. Participants perform continuous bicycle ergometry at moderate intensity (60% HRpeak) and 60-70 rpm for the duration of 30 minutes. | Behavioural | Moderate Continuous Training (MCT) |
Primary outcome
Cardiorespiratory fitness (peak oxygen consumption, VO2peak)
Time frame: Three weeks (day 0 to day 21)
Cardiorespiratory fitness will be measured by peak oxygen consumption achieved in the cardiopulmonary exercise test (CPET). Higher values indicate better cardiorespiratory fitness.
10 secondary outcomes
Peak power output (PPO)
Time frame: Three weeks (day 0 to day 21)
Cognitive performance
Time frame: Three weeks (day 0 to day 21)
Cognitive impairment at baseline
Time frame: Baseline (day 0)
Walking capacity
Time frame: Three weeks (day 0 to day 21)
Physical and psychological Impairment
Time frame: Three weeks (day 0 to day 21)
Fatigue
Time frame: Three weeks (day 0 to day 21)
Anxiety and depressive symptoms
Time frame: Three weeks (day 0 to day 21)
Kynurenine pathway (KP) metabolites
Time frame: Three weeks (day 0 to day 21)
Immune status (blood cells)
Time frame: Time Frame: Three weeks (day 0 to day 21)
Immune status (pro-inflammatory cytokines)
Time frame: Time Frame: Three weeks (day 0 to day 21)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Results publication: 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.
- Results publication: PubMed 28825348Zimmer P, Bloch W, Schenk A, Oberste M, Riedel S, Kool J, Langdon D, Dalgas U, Kesselring J, Bansi J. High-intensity interval exercise improves cognitive performance and reduces matrix metalloproteinases-2 serum levels in persons with multiple sclerosis: A randomized controlled trial. Mult Scler. 2018 Oct;24(12):1635-1644. doi: 10.1177/1352458517728342. Epub 2017 Aug 21.
- Results publication: PubMed 32880214Joisten N, Proschinger S, Rademacher A, Schenk A, Bloch W, Warnke C, Gonzenbach R, Kool J, Bansi J, Zimmer P. High-intensity interval training reduces neutrophil-to-lymphocyte ratio in persons with multiple sclerosis during inpatient rehabilitation. Mult Scler. 2021 Jun;27(7):1136-1139. doi: 10.1177/1352458520951382. Epub 2020 Sep 3.
- Results publication: PubMed 33782190Joisten N, Rademacher A, Warnke C, Proschinger S, Schenk A, Walzik D, Knoop A, Thevis M, Steffen F, Bittner S, Gonzenbach R, Kool J, Bloch W, Bansi J, Zimmer P. Exercise Diminishes Plasma Neurofilament Light Chain and Reroutes the Kynurenine Pathway in Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2021 Mar 29;8(3):e982. doi: 10.1212/NXI.0000000000000982. Print 2021 May.
- Results publication: PubMed 34198345Lea Schlagheck M, Wucherer A, Rademacher A, Joisten N, Proschinger S, Walzik D, Bloch W, Kool J, Gonzenbach R, Bansi J, Zimmer P. VO2peak Response Heterogeneity in Persons with Multiple Sclerosis: To HIIT or Not to HIIT? Int J Sports Med. 2021 Dec;42(14):1319-1328. doi: 10.1055/a-1481-8639. Epub 2021 Jul 1.
- Results publication: PubMed 33836459Rademacher A, Joisten N, Proschinger S, Hebchen J, Schlagheck ML, Bloch W, Gonzenbach R, Kool J, Bansi J, Zimmer P. Do baseline cognitive status, participant specific characteristics and EDSS impact changes of cognitive performance following aerobic exercise intervention in multiple sclerosis? Mult Scler Relat Disord. 2021 Jun;51:102905. doi: 10.1016/j.msard.2021.102905. Epub 2021 Mar 18.
- Results publication: PubMed 33633658Rademacher A, Joisten N, Proschinger S, Bloch W, Gonzenbach R, Kool J, Langdon D, Bansi J, Zimmer P. Cognitive Impairment Impacts Exercise Effects on Cognition in Multiple Sclerosis. Front Neurol. 2021 Jan 28;11:619500. doi: 10.3389/fneur.2020.619500. eCollection 2020.
- Derived from this study: PubMed 37087424Kupjetz M, Joisten N, Rademacher A, Gonzenbach R, Bansi J, Zimmer P. Cycling in primary progressive multiple sclerosis (CYPRO): study protocol for a randomized controlled superiority trial evaluating the effects of high-intensity interval training in persons with primary progressive multiple sclerosis. BMC Neurol. 2023 Apr 22;23(1):162. doi: 10.1186/s12883-023-03187-6.
Related trials for Primary Progressive Multiple Sclerosis
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
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 study director
Klinik Valens
Bansi Jens, PhD principal investigator
Klinik 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 Primary Progressive Multiple Sclerosis and Exercise, 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 13 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 Jun 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 Marie Kupjetz, cand. PhD (+41813031900., Marie.Kupjetz@kliniken-valens.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (peak oxygen consumption, VO2peak) (time frame: Three weeks (day 0 to day 21)). 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 NCT05229861, which also lists 8 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 Jun 2022.