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Normobaric Hypoxic Training and Multiple Sclerosis (MS_EPOXI)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hypoxic training
Normoxic training
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis focused on measuring Hypoxia training, Activity energy expenditure, Immunoregulation, Energy Metabolism, Exercise

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stable immunomodulatory therapy
  • expanded disability status scale score < 4.5
  • body mass index 18.5 - 29.9 kg/m2

Exclusion Criteria:

  • clinically relevant heart, lung, liver, and kidney diseases

Sites / Locations

  • Experimental & Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hypoxic training

Normoxic training

Arm Description

Endurance training

Endurance training

Outcomes

Primary Outcome Measures

Activity energy expenditure measured by indirect calorimetry (respiratory chamber)

Secondary Outcome Measures

Full Information

First Posted
July 24, 2015
Last Updated
July 7, 2022
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02509897
Brief Title
Normobaric Hypoxic Training and Multiple Sclerosis
Acronym
MS_EPOXI
Official Title
Cardiorespiratory, Metabolic and Immunoregulatory Response to Hypoxia in Multiple Sclerosis Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the effects of normobaric hypoxic training on cardiorespiratory fitness, resting, postprandial and exercise activity energy expenditure, immunoregulatory functions and serum erythropoietin levels in relapsing-remitting multiple sclerosis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Hypoxia training, Activity energy expenditure, Immunoregulation, Energy Metabolism, Exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypoxic training
Arm Type
Active Comparator
Arm Description
Endurance training
Arm Title
Normoxic training
Arm Type
Placebo Comparator
Arm Description
Endurance training
Intervention Type
Other
Intervention Name(s)
Hypoxic training
Intervention Description
Hypoxic training 3 times per week four four weeks
Intervention Type
Other
Intervention Name(s)
Normoxic training
Intervention Description
Normoxic training 3 times per week four four weeks
Primary Outcome Measure Information:
Title
Activity energy expenditure measured by indirect calorimetry (respiratory chamber)
Time Frame
Change from baseline at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stable immunomodulatory therapy expanded disability status scale score < 4.5 body mass index 18.5 - 29.9 kg/m2 Exclusion Criteria: clinically relevant heart, lung, liver, and kidney diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedemann Paul, Prof.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Experimental & Clinical Research Center
City
Berlin
ZIP/Postal Code
13125
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30555484
Citation
Mahler A, Balogh A, Csizmadia I, Klug L, Kleinewietfeld M, Steiniger J, Susnjar U, Muller DN, Boschmann M, Paul F. Metabolic, Mental and Immunological Effects of Normoxic and Hypoxic Training in Multiple Sclerosis Patients: A Pilot Study. Front Immunol. 2018 Nov 29;9:2819. doi: 10.3389/fimmu.2018.02819. eCollection 2018.
Results Reference
result
Links:
URL
http://www.frontiersin.org/articles/10.3389/fimmu.2018.02819/full
Description
Results publication

Learn more about this trial

Normobaric Hypoxic Training and Multiple Sclerosis

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