Effects of Individualized, Home-based, Mobile App-guided Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis: a Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 96
- Locations
- 2
- Primary Endpoint
- Fatigue Severity Scale (FSS)
Study Overview
Brief Summary
Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms. Chronic fatigue is the most reported symptom in MS patients (80%). Current pharmacological treatments for MS patients reduce the number of relapses and their severity but do not improve symptoms such as fatigue. Physical activity is a therapy that helps reduce this fatigue, in addition to improving muscular and cardiorespiratory functions. However, the results are not optimal because MS patients remain less active than the general population. The improvement of the benefits of exercise therapy could therefore be based on three approaches: personalization of the training program, home practice and early initiation.
Detailed Description
The objective of this study will be to investigate the effects of individualized home-training, guided by a mobile application, to reduce fatigue in patients with newly (N) and advanced (A) diagnosed MS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Fatigue Severity Scale (FSS)
Time Frame: Week 15
Change in the chronic fatigue score assessed using the FSS questionnaire before and after the training programme. From 1 to 7. The higher the score, the greater the fatigue
Secondary Outcomes
- C-reactive protein (CRP) (mg/l)(Week 15)
- Maximal voluntary contraction (MVC) of the hand grip measurement(Week 16)
- Quality of life questionnaire (SEP-59)(Week 15)
- Maximal oxygen uptake (VO2max) (ml/min)(Week 15)
- Muscle enzymatic activity (UI)(Week 17)
- Percentage of voluntary activation (%)(Week 16)
- Maximal voluntary contraction (MVC) of the knee extensor muscle measurement(Week 16)
- Epworth score(Week 15)
- cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies(Week 17)
- Balance test (s)(Week 16)
- Pittsburgh Sleep Quality Index (PSQI)(Week 15)
- Hospital Anxiety and Depression scale (HAD)(Week 15)