Multiple SclerosisMS_EPOXINCT02509897
Normobaric Hypoxic Training and Multiple Sclerosis
A study testing Hypoxic training and Normoxic training in people with Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Hypoxic training and Normoxic training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- stable immunomodulatory therapy
- expanded disability status scale score < 4.5
- body mass index 18.5 - 29.9 kg/m2
Who cannot join
- clinically relevant heart, lung, liver, and kidney diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiorespiratory, Metabolic and Immunoregulatory Response to Hypoxia in Multiple Sclerosis Patients: A Pilot Study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Hypoxic training, Normoxic training
- Keywords
- Hypoxia training, Activity energy expenditure, Immunoregulation, Energy Metabolism, Exercise
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxic trainingOther
Hypoxic training 3 times per week four four weeks
Normoxic trainingOther
Normoxic training 3 times per week four four weeks
| Study group | Role | What they receive |
|---|---|---|
| Hypoxic training | Active comparator | Endurance training Receives: Other: Hypoxic training |
| Normoxic training | Placebo comparator | Endurance training Receives: Other: Normoxic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity energy expenditure measured by indirect calorimetry (respiratory chamber)
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Maehler, Charite University, Berlin, Germany
- Investigators
- Friedemann Paul, Prof., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509897
- Sponsor's protocol ID
- EpoxiMet
- Acronym
- MS_EPOXI
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2015
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30555484
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorespiratory, Metabolic and Immunoregulatory Response to Hypoxia in Multiple Sclerosis Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT02509897
- Acronym / sponsor ID
- MS_EPOXI / EpoxiMet
- Conditions
- Multiple Sclerosis
- Keywords
- Hypoxia training, Activity energy expenditure, Immunoregulation, Energy Metabolism, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoxic training | Active comparator | Other: Hypoxic trainingEndurance training |
| Normoxic training | Placebo comparator | Other: Normoxic trainingEndurance training |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- stable immunomodulatory therapy
- expanded disability status scale score < 4.5
- body mass index 18.5 - 29.9 kg/m2
Key exclusion criteria (1 listed)
- clinically relevant heart, lung, liver, and kidney diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxic trainingHypoxic training 3 times per week four four weeks | Other | Hypoxic training |
| Normoxic trainingNormoxic training 3 times per week four four weeks | Other | Normoxic training |
Primary outcome
Activity energy expenditure measured by indirect calorimetry (respiratory chamber)
Time frame: Change from baseline at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Results publication: PubMed 30555484Mahler 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 publicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedemann Paul, Prof. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxic training and Normoxic training in people with Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity energy expenditure measured by indirect calorimetry (respiratory chamber) (time frame: Change from baseline at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02509897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.