Trial document





This trial has been registered retrospectively.
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  DRKS00006307

Trial Description

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Title

Effects of Endurance Training under Normobaric, Hypoxic Conditions on Fatigue in
Patients with Multiple Sclerosis: Results of a Randomized, Prospective Pilot Study.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Background:
Fatigue (unusual tiredness), spasticity (unusual stiffness of muscel) and reduced walking ability are the most common and
severe symptoms of multiple sclerosis (MS), but therapy options, especially in Fatigue,
are limited. However, there are indications that physical activity
in form of endurance training, for example, has the potential to improve fatigue and spasticity.
In various studies examining training programs either under altitude conditions (= hypoxic conditions) or normal conditions it has been shown that training under hypoxic conditions leads to an stronger increase of endurance capacity.
This randomized, controlled pilot study investigated for the first time the feasibility and the influence of endurance training in a hypoxic chamber on fatigue, spasticity, and endurance capacity of MS patients.
Methods:
MS patients with fatigue and sustained walking ability were assigned to one of three therapy groups. All patients received a individualized inpatient rehabilitation-programm (e.g. ergo- and physiotherapy). Two of the groups participated in endurance training on a bicycle
ergometer, six days a week for two weeks, either under mean sea level- (21 vol. % O2) or hypoxic conditions (high altitude chamber, 2500m above
sea level/15.5% vol.% O2). The Control group received rehabilitation program only.
Fatigue (questionnaire), walking ability (6-Minute Walk Test (6MinWT) and spasticity (questionnaire) were recorded at the beginning and the end of the study.
The studie showed, that combination of endurance training and hypoxia exposure is practicable in MS patients with sustained walking ability. It increases endurance capacity compared to endurance training at sea level and has the potential to further
increase the positive effects of endurance training on fatigue.

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Brief Summary in Scientific Language

Fatigue, spasticity and reduced walking ability are the most common and
severe symptoms of multiple sclerosis (MS), but therapy options, especially in Fatigue,
are limited.
This randomized, controlled pilot study investigated the feasibility and the
influence of endurance training under normobaric, hypoxic conditions on fatigue,
spasticity, and endurance capacity of MS patients.
MS patients with fatigue and sustained walking ability were
randomized to one of three therapy groups. All patients received symptom-specific inpatient
rehabilitation. Two of the groups participated in endurance training on a bicycle
ergometer, six days a week for two weeks, either under mean sea level- (ergometer
group (EG)) or hypoxic conditions (high altitude chamber group (HCG)) (2500m above
sea level/15.5% vol.% O2). The Control group received rehabilitation program only.
Fatigue (Würzburg Fatigue Inventory in MS (WEIMuS)), walking ability (6-Minute Walk
Test (6MinWT) and spasticity (Multiple Sclerosis Spasticity Scale (MSSS-88)) were
recorded at baseline, 7th and 14th day of the study. Intention- to- treat- (ITT) and perprotocol-
analysis (PPA) where performed.
Data of 32 patients were analyzed (PPA). In both training groups (EG n:8,
HCG n:13) a significant improvement was seen in fatigue (p≤ 0.01) and spasticity
(HCG p≤ 0.01, EG p≤ 0.05). The earliest significant improvement in fatigue was seen
in the HCG (7th day: p≤ 0.01). Walking distance (6MinWT) was only significantly
increased in the HCG (p≤ 0.01).
Combination of endurance training and hypoxia exposure is practicable
in MS patients with sustained walking ability. It increases endurance capacity (6-
MinWT) compared to endurance training at sea level and has the potential to further
increase the positive effects of endurance training on fatigue.

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Organizational Data

  •   DRKS00006307
  •   2014/07/17
  •   [---]*
  •   yes
  •   Approved
  •   2007-123-F, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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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

  •   therapy group: endurance training in normobaric hypoxia.
    symptom-specific inpatient
    rehabilitation (period of 14 days)
    +
    12x 45 min endurance training on a bicycle
    ergometer, six days a week for two weeks, either under hypoxic conditions (high altitude chamber (2500m above
    sea level/15.5% vol.% O2)
  •   therapy group: endurance training in normal conditions.
    symptom-specific inpatient
    rehabilitation (period of 14 days)
    +
    12 x 45 min endurance training on a bicycle
    ergometer, six days a week for two weeks, either under sea level conditions
  •   control group
    symptom-specific inpatient
    rehabilitation over a period of 14 days.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

fatigue: questionnaire: Würzburger Erschöpfungsinventar Multiple Sklerose (WEIMuS). Baseline, 7th and 14th day after baseline.

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Secondary Outcome

Endurance capacity: 6 minute walk test recorded at baseline and 14th day after baseline.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2008/07/14
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients over 18 years of age
MS according to the McDonald
criteria [19] chronic progressive or relapsing-remitting MS with walking ability
(EDSS ≤ 6) and self-reported fatigue
Written informed
consent

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Exclusion Criteria

Patients with severe cardiopulmonary disease
glucocorticosteroid therapy within the previous 30 days,
serious functional limitations (i.e. high spasticity of the legs) limiting the ability to use the
cycle ergometer as well as severe cognitive deficits that would have made it impossible
to understand directions

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Neurologisches Rehabilitationszentrum Quellenhof Bad Wildbad
    • Mr.  Prof. Dr.  Peter  Flachenecker 
    • Kuranlagenallee 2
    • 75323  Bad Wildbad
    • Germany
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    • Medizinische Fakultät der Universität Rostock, Gehlsheimer Str. 20, 18147 Rostock
    • Mr.  Prof. Dr.   Uwe Klaus  Zettl 
    • Gehlsheimer Str. 20
    • 18147  Rostock
    • Germany
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    • Neurologisches Rehabilitationszentrum Quellenhof Bad Wildbad
    • Mr.  Prof. Dr.  Peter  Flachenecker 
    • Kuranlagenallee 2
    • 75323  Bad Wildbad
    • Germany
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Sources of Monetary or Material Support

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    • Neurologisches Rehabilitationszentrum Quellenhof Bad Wildbad
    • Mr.  Prof. Dr.  Peter  Flachenecker 
    • Kuranlagenallee 2
    • 75323  Bad Wildbad
    • Germany
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    • Klinik und Poliklinik für Neurologie Universität Rostock
    • Mr.  Prof. Dr.  Uwe Klaus  Zettl 
    • Gehlsheimer Str. 20
    • 18147  Rostock
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2008/09/30
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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.