Multiple Sclerosis Clinical Trial
Official title:
Intensity-dependent Impacts of Training on Growth Factors BDNF and Cognitive Functions in Persons With Multiple Sclerosis - a Single-center Randomized Controlled Trial
Verified date | August 2016 |
Source | Klinik Valens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system,
accompanied by varying inflammatory manifestations, demyelinization and axonal loss. With
chronic progressive or relapsing-remitting disease onsets persons with MS (pwMS)
progressively develop impaired functional capacity and show reduced physical activity and
cognitive decline compared to healthy controls. The primary aims of rehabilitation in pwMS
are therefore to increase levels of activity and participation leading to increase
independence of the participants. In general exercise ranges from passive physiotherapy-based
interventions to submaximal endurance training sessions. Current recommendations advise pwMS
that exercise should be matched with the individual performance capacities. Exercise training
in pwMS then has the potential to target and improve many components outlined in the
ICF-model.
Cytokines and neurotrophic factors have received increased attention in MS research and
addressed the brain-derived neurotrophic factor (BDNF) as an important mediator of neuronal
regeneration linking the effects of exercise with MS pathogenesis. Data show positive
connections between elevated neurotrophin concentrations, induction of neuroplasticity,
recovery of the motor and cognitive functions and the applied training intensities.
Similarly, intensive and progressive exercise bouts seem to have greater benefits on
cardiorespiratory fitness and maximum voluntary strength in elderly and seniors with
dementia. Therefore, specific exercise prescriptions may be necessary for targeting the
specific impairments also in pwMS.
This study aims to evaluate two different training modalities (intensive versus normal) in
pwMS. It is expected that both modalities will improve cardiorespiratory fitness and
cognitive functions in pwMS. Based on the findings that higher training intensities
facilitate greater benefits, it is expected that pwMS will tolerate the intensive training
intensities and show positive connections to elevated neurotrophin concentrations.
The results will to help to clearer understand the benefits of each type of exercise conveyed
for pwMS and will assist in the development of patient-specific exercise prescriptions.
Status | Completed |
Enrollment | 65 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: Key inclusion criteria for the participants' eligibility are a definite MS diagnosis (McDonald criteria). Participants fulfilling the key inclusion and the following criteria are eligible for this study - EDSS 1.0 - 6.0 - Age 19 - 75 years The presence of any one of the following exclusion criteria will lead to exclusion of the participant: - Persistent infections - Severe cardiovascular and pulmonal diseases (renal failure, hepatic dysfunction, cardiovascular disease) - Severe cardiovascular exacerbations (RR > 240/120, HR above the age predicted maximum of 220-Age) during training - Immunosuppressive therapy the day of CPET - Life style factors and / or persistent addictions (drug or alcohol abuse) - Inability to follow the study procedures (due to psychological disorders or dementia) - Insufficient knowledge of the project language (German) - 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. - 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, - Specific exclusions for the disease under study, - Specific concomitant therapy washout requirements prior to and/or during study participation, - Dietary restrictions Exclusion Criteria: Criteria in which the participant withdraws from this study may be the following: - Inability to comply with the daily schedule - Strong symptom exacerbations - Withdrawal of informed consent - Non-compliance - Disease progression or relapse |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kliniken-Valens | Valens | Sankt Gallen |
Lead Sponsor | Collaborator |
---|---|
Klinik Valens | German Sport University, Cologne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurotrophic Factor BDNF | Short- and long-term changes (pg/ml) of serum levels of the neurotrophic factor BDNF (t1-->t2) | 3-weeks | |
Secondary | Maximum Oxygen consumption (VO2peak) | workload (W) achieved in the cardiopulmonary exercise test. | 3-weeks | |
Secondary | Maximum heart rate (HRmax) | Changes in beats min-1 over three weeks training | 3-weeks | |
Secondary | Maximum workload (Loadmax) | Changes in Watt over three weeks training | 3-weeks | |
Secondary | Fatigue | Changes over three weeks Training of Motor and Cognitive fatigue (Cut-off for fatigue is set for the total score at 43 and for the motoric and cognitive subscores at 22). | 3-weeks | |
Secondary | Health-related Quality of life | Changes of anxiety and Depression over three weeks Training (Cut off for anxiety and Depression are set at 4 Points | 3-weeks | |
Secondary | Cognitive Functions | Cognitive functions will be the changes on the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) and the Trail-Making-Pencil-Test versions A/B (TMT-A/B) both performed at baseline (t1) and repeated at t2 | 3-weeks |
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