Status:
COMPLETED
Training and Energy Management Education to Improve Quality of Life in Persons With Multiple Sclerosis
Lead Sponsor:
Klinik Valens
Collaborating Sponsors:
German Sport University, Cologne
University of Applied Sciences and Arts of Southern Switzerland
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Persons with Multiple Sclerosis (PwMS) often suffer from impaired mobility and reduced aerobic capacity. Moreover, 65% of PwMS recognize fatigue as their most disabling symptom that quickly impacts pa...
Eligibility Criteria
Inclusion
- Definite MS diagnosis (revised McDonald criteria, 2018).
- Age \>18y
- Expanded Disability Status Scale (EDSS) score ≤ 6.5
- Fatigue Scale of Motor and Cognitive function (FSMC) total score \> 43
- Literacy and understanding German
- Informed Consent
Exclusion
- Women who are pregnant or breastfeeding / have the intention to become pregnant during the course of the study
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Cognitive impairment Mini-Mental State Examination (MMSE) \< 21
- Major Depression or Hospital Anxiety and Depression Scale (HADS) \>11 at baseline
- Stem cell treatment in the last 6 months
- Participation in a previous high-intensity interval training (HIIT) or inpatient energy management education (IEME) study
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04356248
Start Date
July 13 2020
End Date
May 11 2022
Last Update
June 10 2022
Active Locations (1)
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1
Kliniken-Valens
Valens, Canton of St. Gallen, Switzerland, 7317