Does deep breathing significantly reduce fatigue in multiple sclerosis patients? A randomized, single-blind, controlled trial
Phase 3
- Conditions
- Multiple Sclerosis-related Fatigue
- Registration Number
- DRKS00024358
- Lead Sponsor
- Department für Psychologie an der Universität Oldenburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
a clinically diagnosed MS and;
- being at least 18 years old;
- suffering from at least weak fatigue (defined by the Multiple Sclerosis Functional Composite (MSFC)
Exclusion Criteria
- An MS-independent psychiatric illness;
- Psychoactive medication (noradrenergic antidepressants, Modafinil or Amantadine);
- Methylprednisolone relapse therapy in the past 4 weeks (immune-suppressant medicine);
- Insufficient success while practicing the vigilance test e.g. as a result of a severe reduction in vision, etc.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is subjective state fatigue, which will be assessed using a visual analogue scale (VAS)<br><br>We expect that the participants in the deep breathing group will recover more from subjective fatigue after the fatigue-inducing alertness task than the participants in the progressive muscle relaxation group of distal body parts.<br><br>Participants' fatigue will be assessed thrice in the second sessions of the study, the first time before an alertness test, the second time after the alertness test and the last time after one of the biofeedback exercises (either deep breathing or progressive muscle relaxation of distal body parts).
- Secondary Outcome Measures
Name Time Method