NCT02408367

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

March 31, 2015

Last Update Submit

April 20, 2015

Conditions

Multiple Sclerosis

Keywords

TrainingCognitionMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (2)

  • Cardiorespiratory parameters

    3 months

  • Lactate

    3 months

Study Arms (2)

Exercise

30 minutes of active training at 75% of the Maximum heart rate achieved in a cardiopulmonary exercise test

Behavioral: ExerciseBehavioral: Relaxation

Relaxation

30 Minutes of passive relaxation

Behavioral: ExerciseBehavioral: Relaxation

Interventions

ExerciseBEHAVIORAL

30 minutes endurance training at 75% of the Maximum heart rate

ExerciseRelaxation
RelaxationBEHAVIORAL

30

ExerciseRelaxation

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Persons with multiple sclerosis holding an score of 1.5-6.0 on the Expanded Disability Staus Ccale (EDSS)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kliniken-Valens

Valens, Canton of St. Gallen, 7317, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jürg Kesselring, Univ.Prof

    Kliniken-Valens, Rehabilitation-Clinic Valens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Bansi, PhD

CONTACT

004181303Jens.Bansi@kliniken-valens.ch

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Jens Bansi

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

CH(1)