High-intensity Training and Its Effects on Neuroplasticity (TRAINUVIMAB)

Klinik Valens

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03652519

BansiJ

Details and patient eligibility

About

Regular physical activity is known to reduce the risk for some neurodegenerative disorders and their symptoms. Several studies have shown positive effects of therapeutic exercise interventions on motor- and cognitive function as well as psychosocial benefits in persons with multiple sclerosis (MS). To improve exercise recommendations, it is necessary to learn more about the underlying biological mechanisms. A reduction of inflammatory stress through physical exercise has been suspected as one key mechanism, mediating the positive effects of exercise in the context of MS (being a "classical" neuro-inflammatory disease). This randomized controlled trial aims to investigate the influence of two different rehabilitative endurance exercise programs (3x/week moderate vs. vigorous endurance exercise) on (1) (anti-)inflammatory immune signalling and (2) various aspects of participation.

Enrollment: 72 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

High-intensity Interval Training (HIIT)

Experimental group

Description:

Participants of the HIIT group will exercise three times per week over a period of three weeks (inpatient rehabilitation) on a cycle ergometer. Exercise intensity will be regulated and heart rate controlled based on the achieved maximum heart rate (HRmax) assessed during the initial Cardiopulmonary Exercise Testing. Each exercise session will last 30 minutes and will be started and finalized with three minutes at low intensity (50% HRmax, warm-up / cool-down). During each exercise session, participants of the HIIT group will perform 5x one-and-a-half Minute high-intensive exercise bouts at 95-100% of their HRmax followed by active breaks of unloaded pedalling over 2 minutes with the aim to achieve 60% HRmax.

Treatment:

Behavioral: Exercise Training

Moderate Continous Training (ST)

Active Comparator group

Description:

Participants of the ST group will exercise three times per week over a period of three weeks (inpatient rehabilitation) on a cycle ergometer. Exercise intensity will be regulated and heart rate controlled based on the achieved maximum heart rate (HRmax) assessed during the initial Cardiopulmonary Exercise Testing. Each exercise session will last 30 minutes and will be started and finalized with three minutes at low intensity (50% HRmax, warm-up / cool-down). During each exercise session, participants of the ST group will exercise 30 minutes continuously at 65% of HRmax. This moderate continous training program represents the standard care at the local rehabilitation clinic.

Treatment:

Behavioral: Exercise Training