Trial document




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  DRKS00017091

Trial Description

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Title

Functional training for persons with multiple sclerosis

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Trial Acronym

FunTraiMS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Initial studies indicate that people with multiple sclerosis (MS) benefit particularly from intensive forms of exercise (including improvement in symptoms of motor skills, cognition, depression, fatigue). In addition, recent findings suggest that exercise interventions in the early stages of MS can delay the progression of the disease. Therefore, the earliest possible exercise is increasingly described as a "promising intervention period".

Based on that, the aim of the current study is to investigate the influence of a 12-week (3x/ week a 60 min.) intensive strength and endurance training in groups on physical, cognitive and psychological well-being as well as on biological factors associated with the disease.
For the participants of this study the aspect of sustainability is important, since the reference to daily life (training in a gym), is given.

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Brief Summary in Scientific Language

Initial studies indicate that individuals with multiple sclerosis (MS) also benefit from intensive training. Both clinical (e.g. motor skills, cognition) and molecular (e.g., anti-inflammatory, blood-brain barrier) effects are described. Particularly, it has been shown that high intensity interval training can lead to a reduction of matrix metalloproteinase-2 in patients with MS, which is in turn associated with a better function of the blood-brain barrier.
However, not much research has been conducted on the effectiveness of regular combined functional training regimens in a non-stationary setting for persons with MS. Thus, the key innovation in our study is to gain new insights into the effectiveness of this training regimen for persons with MS in an early disease stage by investigating changes in the concentration of matrix metalloproteinases in the blood as well as physical and cognitive performance, fatigue, depression, sleeping quality, quality of life, immune function and further MS-related biomarkers.
As part of the planned randomized-controlled trial (RCT), individuals with relapsing remitting MS will be randomized to an intervention and control group (IG, KG). The IG trains for 12 weeks, 3x/week for 60 minutes in a commercial gym. The supervised training program includes intensive strength and endurance components and takes place in groups of max. 10 participants. In order to assess alterations on disease related characteristics, assessments take place before the intervention (t0), six weeks after the start of the intervention, (t1) and immediately after the cessation of the intervention (t2). To investigate acute effects of one single bout of exercise on immunological parameters, blood panels will be drawn immediatley before and after one training session in the 6th week of intervention period. Following the intervention period, subjects of the KG will be offered the same training program.

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Organizational Data

  •   DRKS00017091
  •   2019/04/05
  •   [---]*
  •   yes
  •   Approved
  •   109/2018, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

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Health Condition or Problem studied

  •   G35 -  Multiple sclerosis
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Interventions/Observational Groups

  •   Intervention group:
    The participants will conduct three times a week over 12 weeks in a non-stationary and community-based setting with regular combined functional endurance and resistance training regimens. Each training session will take 60 minutes and will be in groups of 10 (maximum).
  •   Passive control group: Following the investigation period, the passive control group will also be offered the same program of exercises over 12-weeks.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

matrix-metalloproteinases in the Serum (t0, t1, t2)

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Secondary Outcome

Number and proportions of further circulating immune markers associated with MS and exercise (t0, t1, t2):
metabolites of the Tryptophan-Kynurenine pathway and enzymes, cytokines, lipid markers and T-cells

Strength (t0, t2):
Hypothetical One Repetition Maximum strength in relevant muscle groups

Endurance capacity (t0, t2):
Peak oxygen uptake (VO2peak) reflecting their cardiorespiratory fitness measured during a maximal incremental exercise test on a cycle ergometer.

Further secondary outcomes: actigraphic data (t0, t1, t2); body composition (BIA) (t0, t2)
cognitive Performance (t0, t2), i.e. information processing speed, verbal memory and visual memory; questionnaires to measure fatigue (t0, t2), depression (t0, t2), sleeping quality (t0, t2) and quality of life (t0, t2)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/08/05
  •   72
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

Relapsing remitting multiple sclerosis; EDSS-Scale (Expanded Disability Status Scale): 0-4

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Exclusion Criteria

Acute episode or exacerbation of multiple sclerosis symptoms during intervention,
cardiac preload,
concomitant disease state (internistic or neurological) affecting study end points (e.g. tumor diseases),
orthopaedic diseases excluding from the exercise program,
pregnancy or breast feeding

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Addresses

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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin
    • Am Sportpark Müngersdorf 6
    • 50933   Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und SportmedizinAbteilung molekulare und zelluläre Sportmedizin
    • Mr.  Dr. Dr.  Philipp  Zimmer 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und SportmedizinAbteilung molekulare und zelluläre Sportmedizin
    • Mr.  Dr. Dr.  Philipp  Zimmer 
    • Am Sportpark Müngersdorf 6
    • 50933   Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.