Multiple Sclerosis Clinical Trial
— MS_EPOXIOfficial title:
Cardiorespiratory, Metabolic and Immunoregulatory Response to Hypoxia in Multiple Sclerosis Patients: A Pilot Study
| NCT number | NCT02509897 |
| Other study ID # | EpoxiMet |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2015 |
| Est. completion date | July 2018 |
| Verified date | July 2022 |
| Source | Charite University, Berlin, Germany |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | July 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 60 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Experimental & Clinical Research Center | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany |
Germany,
Mähler A, Balogh A, Csizmadia I, Klug L, Kleinewietfeld M, Steiniger J, Šušnjar U, Müller DN, Boschmann M, Paul F. Metabolic, Mental and Immunological Effects of Normoxic and Hypoxic Training in Multiple Sclerosis Patients: A Pilot Study. Front Immunol. 2 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Activity energy expenditure measured by indirect calorimetry (respiratory chamber) | Change from baseline at 4 weeks |
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