Multiple SclerosisNCT02408367
Intensity Depended Impacts on Cognitive Functions in Persons With Multiple Sclerosis - a Pilot Study
An observational study of Multiple Sclerosis, run by Jens Bansi at 1 site in Switzerland.
Trial summary
Multiple Sclerosis (MS) is a chronic autoimmune disease where lymphocytes inflict damage to the axons and myelin sheaths of the central nervous system. Persons with multiple sclerosis (pwMS) were long advised to avoid physical activity but the benefits of exercise to improve cardiovascular and cognitive functions in… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exercise and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to May 2015
- Phase
- Observational
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with multiple sclerosis holding an score of 1.5-6.0 on the Expanded Disability Staus Ccale (EDSS)
Who may be able to join
- Expanded Disability status scale (EDSS) score of 1.5 - 6.0
Who cannot join
- Persisted infections, acute psychotic disorders, cardiovascular and pulmonal diseases, neuropsychological disorders that serverly impact the assessment or were psychotropic medication within the last six week.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kliniken-Valens
Valens, Canton of St. Gallen, 7317
Jens Bansi, PhD, 004181303 ext. 1900, Jens.Bansi@kliniken-valens.ch
About this study
Official title: Intensity Depended Impact of a Single Exercise Bout on Cognitive Functions in Persons With Multiple Sclerosis - a Pilot Study
Multiple Sclerosis (MS) is a chronic autoimmune disease where lymphocytes inflict damage to the axons and myelin sheaths of the central nervous system. Persons with multiple sclerosis (pwMS) were long advised to avoid physical activity but the benefits of exercise to improve cardiovascular and cognitive functions in pwMS have become important aspects of standardized rehabilitation programs. Recent findings show that the achieved adaptations through exercise are associated with the intensity dependent lactate increases during exercise. This dose-response relationship between the mode and the exercise intensity implicates the relevance of the exercise protocol as higher exercise intensities seem to facilitate greater benefits, also in pwMS.
This pilot study evaluates the influences of acute bout of moderate physical exercise (cycling) and relaxation on cognitive functions at three time points.
Read more
Primary outcomes are the differences (at timepoint t2) of cognitive functions assessed via the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised (BVMT-R) T1-3 of the BICAMS battery.
Results should into a randomised controlled Trial that investigates the specific influences of a three-week training intervention on Brain-derived neurotrophic factors (BDNF), Insulin Growth Factor-1 (IGF-1) and Vascular Endothelial Growth Factor (VEGF) as central neurobiological parameters of neuroplasticity, cardiorespiratory Fitness and cognitive functions.
Read the detailed description
Objectives To determine responses of an acute moderate exercise bout on cognitive functions in pwMS.
Hypothesis
- Comparisons of different Training modes: exercise (overland cycling) versus relaxation
- Improvements of cognitive functionning (Memory, processing Speed) on the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised (BVMT-R) T1-3
- Correlations between the intensity-dependent lactate increases and cognitive functions
Experimental design Two-pronged, case controlled study. Randomization of 20 MS patients into a Group "Exercise" (n=10) - that perform 30 minutes cycling on an Ergometer - or "Relaxation (n=10) that perform relaxation in a comfortable and quiet environment. Both groups crossover at t2 into the respective Group. The study is set into the normal rehabilitation program and participants are given physician clearance, are informed about the study and give their written consent before the study starts.
Cognitive assessment is performed with the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised (BVMT-R) T1-3.
SDMT tests information of processing speed. The test consists of single digits paired with abstract symbols. Rows of the nine symbols are arranged pseudo-randomly. The participant must say the number that corresponds with each symbol. The SDMT can be completed within 5 min, including instructions, practice and testing. The good psychometric properties of the SDMT are well described.
BVMT-R T1-3 requires the the participant to inspect a 2 × 3 stimulus array of abstract geometric figures. There are three learning trials of 10 s. The array is removed and the patient is required to draw the array from memory, with the correct shapes in the correct position. The psychometric properties of the BVMT-R T1-3 are good. Cognitive functions are assessed at time points t1 and t2 after Exercise / Relaxation.
At baseline participants perform a progressive cardiopulmonary exercise test (CPET) on a cycle ergometer (Ergoline 800, Germany). Cardiopulmonary fitness level was monitored by direct and continuous measurements (breath by breath) of maximum oxygen consumption (VO2peak) by ergospirometer (PanGas, CPX, Germany).
The exercise protocol consisted of (a) first 3 minutes at rest (no pedalling) on the cycle ergometer; (b) 3 minutes of unloaded pedalling as a warm up; (c) testing phase until the participant reached a symptom limited maximum. Workload was continuously ramp type increased by 5-10 Watts every minute to ensure 8-12 minutes of testing; (d) the final 3 minutes were unloaded pedalling to cool down. Heart rate (Polar Electro, Kempele, Finland) and blood pressure (Riva Rocci) were monitored for the last 10 seconds every 2 minutes during the test. The 10-point BORG scale therapy short form assessed the rate of perceived exertion (RPE) at phases (c) and (d). Peak oxygen consumption (VO2peak) was defined as the highest VO2 value when the following criteria were attained: respiratory equivalent ratio (RER) > 1.10; peak heart rate (HRpeak) within 10 min-1 of age predicted maximum and rating of exertion (RPE > 8.5).
The exercise bout consists of 30 minutes physiologically defined heart rate controlled cycling at 50-60 rounds per minutes (rpm) at the lactate threshold (equal to 75% of HRpeak or 60% VO2max).
Relaxation consists of 30 minutes resting in a comfortable and quiet surrounding. Exercise and Relaxation are performed at timepoints t1 and t2.
- Conditions
- Multiple Sclerosis
- Being tested
- Exercise, Relaxation
- Keywords
- Training, Cognition, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
30 minutes endurance training at 75% of the Maximum heart rate
RelaxationBehavioural
30
| Study group | Role | What they receive |
|---|---|---|
| Exercise | 30 minutes of active training at 75% of the Maximum heart rate achieved in a cardiopulmonary exercise test Receives: Behavioral: Exercise; Behavioral: Relaxation | |
| Relaxation | 30 Minutes of passive relaxation Receives: Behavioral: Exercise; Behavioral: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief International Cognitive Assessment of Multiple Sclerosis (BICAMS)
Cognitive assessment battery consisting of Symbol Digit modality test (SDMT) and the Brief Visuospatial Memory Test Revised (BVMT-R) T1-3.
Measured: 3 months
Secondary outcomes (2)
Cardiorespiratory parameters
Resting and maximum heart rate achieved in cardiopulmonary exercise test
Measured: 3 months
Lactate
Lactate concentrations under rest, at the thresholds (lactate and respiratory compensation Point)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jens Bansi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Bansi, Klinik Valens
- Investigators
- Jürg Kesselring, Univ.Prof, Principal investigator, Kliniken-Valens, Rehabilitation-Clinic Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408367
- Sponsor's protocol ID
- KValens
- Status last verified
- Apr 2015
- First submitted
- 31 Mar 2015
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity Depended Impact of a Single Exercise Bout on Cognitive Functions in Persons With Multiple Sclerosis - a Pilot Study
- ClinicalTrials.gov ID
- NCT02408367
- Acronym / sponsor ID
- KValens
- Conditions
- Multiple Sclerosis
- Keywords
- Training, Cognition, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jens BansiUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 3 Apr 2015 (estimated)
- 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.
Multiple Sclerosis (MS) is a chronic autoimmune disease where lymphocytes inflict damage to the axons and myelin sheaths of the central nervous system. Persons with multiple sclerosis (pwMS) were long advised to avoid physical activity but the benefits of exercise to improve cardiovascular and cognitive functions in pwMS have become important aspects of standardized rehabilitation programs. Recent findings show that the achieved adaptations through exercise are associated with the intensity dependent lactate increases during exercise. This dose-response relationship between the mode and the exercise intensity implicates the relevance of the exercise protocol as higher exercise intensities seem to facilitate greater benefits, also in pwMS.
This pilot study evaluates the influences of acute bout of moderate physical exercise (cycling) and relaxation on cognitive functions at three time points.
Primary outcomes are the differences (at timepoint t2) of cognitive functions assessed via the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised (BVMT-R) T1-3 of the BICAMS battery.
Results should into a randomised controlled Trial that investigates the specific influences of a three-week training intervention on Brain-derived neurotrophic factors (BDNF), Insulin Growth Factor-1 (IGF-1) and Vascular Endothelial Growth Factor (VEGF) as central neurobiological parameters of neuroplasticity, cardiorespiratory Fitness and cognitive functions.
Detailed description
Objectives To determine responses of an acute moderate exercise bout on cognitive functions in pwMS.
Hypothesis
- Comparisons of different Training modes: exercise (overland cycling) versus relaxation
- Improvements of cognitive functionning (Memory, processing Speed) on the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised (BVMT-R) T1-3
- Correlations between the intensity-dependent lactate increases and cognitive functions
Experimental design Two-pronged, case controlled study. Randomization of 20 MS patients into a Group "Exercise" (n=10) - that perform 30 minutes cycling on an Ergometer - or "Relaxation (n=10) that perform relaxation in a comfortable and quiet environment. Both groups crossover at t2 into the respective Group. The study is set into the normal rehabilitation program and participants are given physician clearance, are informed about the study and give their written consent before the study starts.
Cognitive assessment is performed with the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised (BVMT-R) T1-3.
SDMT tests information of processing speed. The test consists of single digits paired with abstract symbols. Rows of the nine symbols are arranged pseudo-randomly. The participant must say the number that corresponds with each symbol. The SDMT can be completed within 5 min, including instructions, practice and testing. The good psychometric properties of the SDMT are well described.
BVMT-R T1-3 requires the the participant to inspect a 2 × 3 stimulus array of abstract geometric figures. There are three learning trials of 10 s. The array is removed and the patient is required to draw the array from memory, with the correct shapes in the correct position. The psychometric properties of the BVMT-R T1-3 are good. Cognitive functions are assessed at time points t1 and t2 after Exercise / Relaxation.
At baseline participants perform a progressive cardiopulmonary exercise test (CPET) on a cycle ergometer (Ergoline 800, Germany). Cardiopulmonary fitness level was monitored by direct and continuous measurements (breath by breath) of maximum oxygen consumption (VO2peak) by ergospirometer (PanGas, CPX, Germany).
The exercise protocol consisted of (a) first 3 minutes at rest (no pedalling) on the cycle ergometer; (b) 3 minutes of unloaded pedalling as a warm up; (c) testing phase until the participant reached a symptom limited maximum. Workload was continuously ramp type increased by 5-10 Watts every minute to ensure 8-12 minutes of testing; (d) the final 3 minutes were unloaded pedalling to cool down. Heart rate (Polar Electro, Kempele, Finland) and blood pressure (Riva Rocci) were monitored for the last 10 seconds every 2 minutes during the test. The 10-point BORG scale therapy short form assessed the rate of perceived exertion (RPE) at phases (c) and (d). Peak oxygen consumption (VO2peak) was defined as the highest VO2 value when the following criteria were attained: respiratory equivalent ratio (RER) > 1.10; peak heart rate (HRpeak) within 10 min-1 of age predicted maximum and rating of exertion (RPE > 8.5).
The exercise bout consists of 30 minutes physiologically defined heart rate controlled cycling at 50-60 rounds per minutes (rpm) at the lactate threshold (equal to 75% of HRpeak or 60% VO2max).
Relaxation consists of 30 minutes resting in a comfortable and quiet surrounding. Exercise and Relaxation are performed at timepoints t1 and t2.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | – | Behavioral: Exercise, Behavioral: Relaxation30 minutes of active training at 75% of the Maximum heart rate achieved in a cardiopulmonary exercise test |
| Relaxation | – | Behavioral: Exercise, Behavioral: Relaxation30 Minutes of passive relaxation |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with multiple sclerosis holding an score of 1.5-6.0 on the Expanded Disability Staus Ccale (EDSS)
Key inclusion criteria (1 listed)
- Expanded Disability status scale (EDSS) score of 1.5 - 6.0
Key exclusion criteria (1 listed)
- Persisted infections, acute psychotic disorders, cardiovascular and pulmonal diseases, neuropsychological disorders that serverly impact the assessment or were psychotropic medication within the last six week.
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 |
|---|---|---|
| Exercise30 minutes endurance training at 75% of the Maximum heart rate | Behavioural | Exercise, Relaxation |
| Relaxation30 | Behavioural | Exercise, Relaxation |
Primary outcome
Brief International Cognitive Assessment of Multiple Sclerosis (BICAMS)
Time frame: 3 months
Cognitive assessment battery consisting of Symbol Digit modality test (SDMT) and the Brief Visuospatial Memory Test Revised (BVMT-R) T1-3.
2 secondary outcomes
Cardiorespiratory parameters
Time frame: 3 months
Lactate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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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.
Jürg Kesselring, Univ.Prof principal investigator
Kliniken-Valens, Rehabilitation-Clinic Valens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Jens Bansi 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 1 inclusion and 1 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 21 Apr 2015. 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 (004181303 ext. 1900, 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?
Brief International Cognitive Assessment of Multiple Sclerosis (BICAMS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2015; AzTrials last refreshed its copy on 29 Oct 2026.