Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intensity Depended Impacts on Cognitive Functions in Persons With Multiple Sclerosis - a Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02408367
Recruitment Status : Unknown
Verified April 2015 by Jens Bansi, Klinik Valens.
Recruitment status was:  Recruiting
First Posted : April 3, 2015
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Jens Bansi, Klinik Valens

Brief 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 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.


Condition or disease Intervention/treatment
Multiple Sclerosis Behavioral: Exercise Behavioral: Relaxation

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Intensity Depended Impact of a Single Exercise Bout on Cognitive Functions in Persons With Multiple Sclerosis - a Pilot Study
Study Start Date : February 2015
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Exercise
30 minutes of active training at 75% of the Maximum heart rate achieved in a cardiopulmonary exercise test
Behavioral: Exercise
30 minutes endurance training at 75% of the Maximum heart rate

Behavioral: Relaxation
30

Relaxation
30 Minutes of passive relaxation
Behavioral: Exercise
30 minutes endurance training at 75% of the Maximum heart rate

Behavioral: Relaxation
30




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cardiorespiratory parameters [ Time Frame: 3 months ]
    Resting and maximum heart rate achieved in cardiopulmonary exercise test

  2. Lactate [ Time Frame: 3 months ]
    Lactate concentrations under rest, at the thresholds (lactate and respiratory compensation Point)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Persons with multiple sclerosis holding an score of 1.5-6.0 on the Expanded Disability Staus Ccale (EDSS)
Criteria

Inclusion Criteria:

  • Expanded Disability status scale (EDSS) score of 1.5 - 6.0

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408367


Contacts
Layout table for location contacts
Contact: Jens Bansi, PhD 004181303 ext 1900 Jens.Bansi@kliniken-valens.ch

Locations
Layout table for location information
Switzerland
Kliniken-Valens Recruiting
Valens, Sankt Gallen, Switzerland, 7317
Contact: Jens Bansi, PhD    004181303 ext 1900    Jens.Bansi@kliniken-valens.ch   
Sponsors and Collaborators
Jens Bansi
Investigators
Layout table for investigator information
Principal Investigator: Jürg Kesselring, Univ.Prof Kliniken-Valens, Rehabilitation-Clinic Valens

Layout table for additonal information
Responsible Party: Jens Bansi, Dr Jens Bansi, Klinik Valens
ClinicalTrials.gov Identifier: NCT02408367     History of Changes
Other Study ID Numbers: KValens
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by Jens Bansi, Klinik Valens:
Training
Cognition
Multiple Sclerosis

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases