Multiple Sclerosis-related Fatigue
Conditions
Interventions
Group 1: The deep breathing group (verum), which would perform deep breathing exercises. We will instruct the deep-breathing group to inhale for 5 seconds and exhale for 5 seconds in the supine positi
Sponsors
Department für Psychologie an der Universität Oldenburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is subjective state fatigue, which will be assessed using a visual analogue scale (VAS) 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. 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
| Measure | Time frame |
|---|---|
| The secondary outcome is the cardiovagal reflex. We will measure cardiogaval reflex with heart rate variability (HRV) analysis, which is an objective and non-invasive quantitative autonomic testing tool for testing cardiovagal autonomic dysfunction, in tracking the natural fluctuations of autonomic function within minutes (Novak, 2011), and in predicting fatigue severity (Crosswell, Lockwood, Ganz & Bower, 2014). Participants' cardiovagal reflex will be assessed in the first session of the study. We will measure cardiovagal reflex through heart rate variability in conjunction with deep breathing (DB), with the Blood Volume Pulse Head Sensor of the NeXus 4 Biofeedback-System of Hasomed (Inc. MM. Nexus 4), which evaluates changes in the instant heart rate that is provoked by DB at 6 breaths/min. Because heart responses to DB are mediated by the vagal nerve, the test is also referred to as cardiovagal testing. We will record a 5 minutes baseline before proceeding with the DB test. HRV analysis offers the important advantage that it can track dynamic changes of cardiac autonomic function within minutes and it is a reliable and sensitive clinical test for early detection of cardiovagal dysfunction in a wide range of autonomic disorders. We will repeat these recordings after the PMR and DB biofeedback training sessions. | — |
Countries
Germany
Contacts
Public ContactGuadalupe Garis
Department für Psychologie an der Universität Oldenburg
Outcome results
None listed