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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 25 November 2019
Main ID:  NCT03652519
Date of registration: 14/08/2018
Prospective Registration: Yes
Primary sponsor: Klinik Valens
Public title: High-intensity Training and Its Effects on Neuroplasticity TRAINUVIMAB
Scientific title: Influence of Different Rehabilitative Aerobic Exercise Programs on (Anti-) Inflammatory Immune Signalling, Cognitive Performance and Processing Skills in Persons With MS - A Randomized Controlled Trial
Date of first enrolment: November 21, 2018
Target sample size: 72
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03652519
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Switzerland
Contacts
Name:     Jens Bansi, PhD
Address: 
Telephone:
Email:
Affiliation:  Klinik Valens
Key inclusion & exclusion criteria

Inclusion Criteria:

- Definite diagnosis of MS (according to the revised McDonald criteria 2010)

- Expanded Disability Status Scale 3.0 - 6.0

- Age > 21

- Relapsing remitting or secondary progressive MS

- Informed Consent as documented by signature

Exclusion Criteria:

- Contraindications to the class of drugs under study, e.g. known hypersensitivity or
allergy to class of drugs or the investigational product,

- Define drugs not allowed during the study or for specific periods of time prior to the
administration of the test dose,

- Women who are pregnant or breast feeding,

- Intention to become pregnant during the course of the study,

- Lack of safe contraception, defined as: Female participants of childbearing potential,
not using and not willing to continue using a medically reliable method of
contraception for the entire study duration, such as oral, injectable, or implantable
contraceptives, or intrauterine contraceptive devices, or who are not using any other
method considered sufficiently reliable by the investigator in individual cases.

- Female participants who are surgically sterilised / hysterectomised or post-menopausal
for longer than 2 years are not considered as being of child bearing potential.

- Other clinically significant concomitant disease states (e.g., renal failure, hepatic
dysfunction, cardiovascular disease, etc.),

- Known or suspected non-compliance, drug or alcohol abuse,

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant,

- Participation in another study with investigational drug within the 30 days preceding
and during the present study,

- Previous enrolment into the current study,

- Enrolment of the investigator, his/her family members, employees and other dependent
persons



Age minimum: 21 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Behavioral: Exercise Training
Primary Outcome(s)
Tregs [Time Frame: Three weeks (day 0 to day 21)]
Secondary Outcome(s)
Assessment of Motor and Processing Skills (AMPS) [Time Frame: Three weeks (day 0 to day 21)]
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) [Time Frame: Three weeks (day 0 to day 21)]
Endurance capacity [Time Frame: Three weeks (day 0 to day 21)]
Fatigue Scale of Motor and cognitive function (FSMC) [Time Frame: Three weeks (day 0 to day 21)]
Hospital Anxiety and Depression Scale (HADS) [Time Frame: Three weeks (day 0 to day 21]
Immune status [Time Frame: Three weeks (day 0 to day 21)]
Migratory Potential of peripheral mononuclear cells (PBMC) [Time Frame: Three weeks (day 0 to day 21)]
Patient-Reported Outcome Measurement Information System (PROMIS) [Time Frame: Three weeks (day 0 to day 21)]
Soluble factors (cytokines, tryptophan metabolites, blood brain barrier markers) [Time Frame: Change from baseline (day 0) to directly after and 3-hours after the first exercise session (on day 0) and over 3-weeks (day 0 to day 21)]
Test battery of attention (TAP) [Time Frame: Three weeks (day 0 to day 21)]
Secondary ID(s)
BansiJ
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
German Sport University, Cologne
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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