NCT02509897

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

2.4 years

First QC Date

July 24, 2015

Last Update Submit

July 7, 2022

Conditions

Multiple Sclerosis

Keywords

Hypoxia trainingActivity energy expenditureImmunoregulationEnergy MetabolismExercise

Outcome Measures

Primary Outcomes (1)

  • Activity energy expenditure measured by indirect calorimetry (respiratory chamber)

    Change from baseline at 4 weeks

Study Arms (2)

Hypoxic training

ACTIVE COMPARATOR

Endurance training

Other: Hypoxic training

Normoxic training

PLACEBO COMPARATOR

Endurance training

Other: Normoxic training

Interventions

Hypoxic trainingOTHER

Hypoxic training 3 times per week four four weeks

Hypoxic training
Normoxic trainingOTHER

Normoxic training 3 times per week four four weeks

Normoxic training

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Experimental & Clinical Research Center

Berlin, 13125, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30555484RESULT

Related Links

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Friedemann Paul, Prof.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 28, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2017

Study Completion

July 1, 2018

Last Updated

July 11, 2022

Record last verified: 2022-07

Locations

DE(1)