TREating FAtigue in Multiple Sclerosis: Aerobic training

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Nervous System Diseases

• Registration Number: ISRCTN69520623
• Lead Sponsor: VU University Medical Center (Netherlands)

Brief Summary

2013 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/23938046 protocol 2014 Results article in https://pubmed.ncbi.nlm.nih.gov/24850225 results 2015 Results article in https://pubmed.ncbi.nlm.nih.gov/25789625 results 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26358158 results (added 24/01/2019) 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28528566 results (added 24/01/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27233157 results (added 24/01/2019) 2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24850225 results (added 24/01/2019) 2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24677255 results (added 24/01/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26014607 results (added 24/01/2019) 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/25789625 results (added 24/01/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36621163/ Secondary analysis (added 10/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-19
• Study Completion: 2014-04-01
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Diagnosis of MS according to the criteria of McDonald
2. Able to walk with no more than one unilateral walking aid i.e. able to walk with no more than one unilateral walking aid
3. Suffering from fatigue, defined as a score higher than 35 on the subscale fatigue of the Checklist Individual Strength (CIS)
4. Age between 18-70 years

Exclusion Criteria

1. Patients using in the last three months prior to inclusion Amantadine, Modafinil, Ritalin or Pemoline for their fatigue
2. Major depression

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Fatigue: checklist individual strength (CIS) subscale fatigue <br>2. Participation: impact on participation and autonomy (IPA)

Secondary Outcome Measures

Name	Time	Method
1. Medical outcome study short form 36 (SF36) <br>2. Rehabilitation activities profile (RAP) <br>3. Fatigue severity scale (FSS) <br>4. Checklist individual strength (CIS) subscales motivation, concentration, activity modified fatigue impact scale (MFIS)