Normobaric Hypoxic Training and Multiple Sclerosis | NCT02509897

Studies
Normobaric Hypoxic Training and Multiple Sclerosis

NCT02509897

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 11, 2022Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Multiple Sclerosis

Interventions

Hypoxic training
Normoxic training

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Dec 2017Actual

Completion Date

Jul 2018Actual

First Submitted Date

Jul 24, 2015

First Submission Date that Met QC Criteria

Jul 27, 2015

First Posted Date

Jul 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2022

Last Update Posted Date

Jul 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anja Maehler, Principal Investigator, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypoxic training	Active Comparator	Endurance training	Other: Hypoxic training
Normoxic training	Placebo Comparator	Endurance training	Other: Normoxic training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypoxic training	Other	Hypoxic training 3 times per week four four weeks	Hypoxic training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Activity energy expenditure measured by indirect calorimetry (respiratory chamber)		Change from baseline at 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Friedemann Paul, Prof.	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Experimental & Clinical Research Center		Berlin		13125	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30555484	Result	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.

ID	Term
D009103	Multiple Sclerosis
D009043	Motor Activity

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases