TREating FAtigue in Multiple Sclerosis: Aerobic training

ISRCTN	ISRCTN69520623
DOI	https://doi.org/10.1186/ISRCTN69520623
Secondary identifying numbers	ZonMw 60-61300-98-024; CCMO NL33451.029.10

Submission date: 13/07/2011
Registration date: 19/07/2011
Last edited: 10/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Heleen Beckerman
Scientific

Dept Rehabilitation Medicine
VU University Medical Center
PO BOX 7057
Amsterdam
1007 MB
Netherlands

Study information

Study design	Randomized two armed trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomized clinical trial looking at disabling fatigue in multiple sclerosis occurs frequently. How should it be treated? A randomized clinical trial
Study acronym	TREFAMS-A
Study hypothesis	What is the effect of regular Aerobic Training (AT) on fatigue and participation in patients with Multiple Sclerosis on fatigue and participation in patients with Multiple Sclerosis? Can this effect be attributed to an increase in fitness parameters?
Ethics approval(s)	The Medical Ethics Committee of the VU University Medical Center, 5 April 2011 Ref: 2010/289
Condition	Multiple Sclerosis
Intervention	1. Aerobic Training consists of 12 individual therapist-supervised 45-minute physical exercise sessions with an intensity of at least 60%VO2max in a period of 4 months 2. In the first 8 weeks one physiotherapist-supervised session will be given per week, in the subsequent 8 weeks one therapist-supervised session will be given every other week 3. The sessions include a warming-up and cooling down 4. In addition, patients will perform two aerobic training sessions per week at home of the same duration and at the same intensity as measured by heart rate 5. Control treatment for each RCT of the TREFAMS-ACE research programme consists of currently available standardized written patient information and will be provided in a standardized manner by an MS nurse. Patients receive this information package personally in the first week 6. In week 6 and 16, 45-minute appointments with the MS nurse will be scheduled in order to ask questions about the information package 7. This control treatment covers two important aspects that we want to control for 7.1. Good information about MS related fatigue, and 7.2. Attention of a professional who has experience in MS in order to reassure the patient that his concerns or questions will be taken seriously 7.3. The MS nurses will receive instructions on how to provide the information without additional therapeutic interventions or specific personal advises 8. It is a two-arm trial
Intervention type	Other
Primary outcome measure	1. Fatigue: checklist individual strength (CIS) subscale fatigue 2. Participation: impact on participation and autonomy (IPA)
Secondary outcome measures	1. Medical outcome study short form 36 (SF36) 2. Rehabilitation activities profile (RAP) 3. Fatigue severity scale (FSS) 4. Checklist individual strength (CIS) subscales motivation, concentration, activity modified fatigue impact scale (MFIS)
Overall study start date	15/09/2011
Overall study end date	01/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	Both
Target number of participants	90
Participant 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
Participant exclusion criteria	1. Patients using in the last three months prior to inclusion Amantadine, Modafinil, Ritalin or Pemoline for their fatigue 2. Major depression
Recruitment start date	15/09/2011
Recruitment end date	01/04/2014

Locations

Countries of recruitment

Netherlands

Study participating centre

Dept Rehabilitation Medicine

Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Center (Netherlands)
University/education

Department Rehabilitation Medicine
PO Box 7057
Amsterdam
1007 MB
Netherlands

Website	http://www.vumc.com/patientcare/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

The Netherlands Organization for Health Research and Development Rehabilitation Research Program II, Fonds NutsOhra (ZonMw 60-61300-98-024)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	12/08/2013		Yes	No
Results article	results	01/07/2014		Yes	No
Results article	results	19/03/2015		Yes	No
Results article	results	11/09/2015	24/01/2019	Yes	No
Results article	results	01/10/2017	24/01/2019	Yes	No
Results article	results	01/11/2016	24/01/2019	Yes	No
Results article	results	01/07/2014	24/01/2019	Yes	No
Results article	results	01/08/2014	24/01/2019	Yes	No
Results article	results	01/02/2016	24/01/2019	Yes	No
Results article	results	19/03/2015	24/01/2019	Yes	No
Results article	Secondary analysis	28/12/2022	10/01/2023	Yes	No

Editorial Notes

10/01/2023: Publication reference added.
24/01/2019: Publication references added.