TREating FAtigue in Multiple Sclerosis: Energy conservation management
| ISRCTN | ISRCTN82353628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82353628 |
| Secondary identifying numbers | ZonMw 60-61300-98-024; CCMO NL33451.029.10 |
- Submission date
- 13/07/2011
- Registration date
- 19/07/2011
- Last edited
- 11/03/2015
- 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 of protocol
Not provided at time of registration
Contact information
Dr Heleen Beckerman
Scientific
Scientific
Dept Rehabilitation Medicine
VU University Medical Center
PO Box 7057
Amsterdam
1007 MB
Netherlands
Study information
| Study design | Randomized clinical 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 | Disabling fatigue in multiple sclerosis occurs frequently: how should it be treated? A randomized clinical trial |
| Study acronym | TREFAMS-E |
| Study objectives | What is the effect of Energy Conservation Management (ECM) advices on fatigue and participation in patients with Multiple Sclerosis? Can this effect be attributed to the use of ergonomic advices given or adhering to altered time-schedules? |
| Ethics approval(s) | 1. The Medical Ethics Committee of the VU University Medical Center (2010/289), 05/04/2011 2. The Board of the Erasmus Medical Center Rotterdam, 27/06/2011 |
| Health condition(s) or problem(s) studied | Multiple Sclerosis |
| Intervention | 1. Energy Conservation Management consists of 12 individual therapist-supervised 45-minute sessions, in which energy-management and ergonomic advices are given, in a period of 4 months; in the first 8 weeks one occupational therapist-supervised session will be given per week, in the subsequent 8 weeks one therapist-supervised session will be given every other week. In addition, individualized home-assignments are given. 2. 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. In week 6 and 16, 45-minute appointments with the MS nurse will be scheduled in order to ask questions about the information package. This control treatment covers two important aspects that we want to control for: 2.1. Good information about MS related fatigue, and 2.2. Attention of a professional who has experience in MS in order to reassure the patient that his concerns or questions will be taken seriously. The MS nurses will receive instructions on how to provide the information without additional therapeutic interventions or specific personal advises |
| Intervention type | Other |
| Primary outcome measure | 1. Fatigue: Checklist Individual Strength (CIS) subscale fatigue 2. Participation: Impact on Participation and Autonomy (IPA) The 6 time points are: week-1, week 0, week 8, week 16, week 26 and week 52 |
| 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 5. Modified Fatigue Impact Scale (MFIS) The 6 time points are: week -1, week 0, week 8, week 16, week 26 and week 52 |
| Overall study start date | 15/09/2011 |
| Completion 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 |
| Key inclusion criteria | Ambulatory multiple sclerosis (MS) patients fulfulling the following enrollment criteria: 1. Age between 18-70 years 2. Diagnosis of MS according to the criteria of McDonald 3. Able to walk with no more than one unilateral walking aid i.e. able to walk with no more than one unilateral walking aid 4. Suffering from fatigue, defined as a score higher than 35 on the subscale fatigue of the Checklist Individual Strength (CIS) |
| Key exclusion criteria | 1. Patients using in the last three months prior to inclusion amantadine, modafinil, Ritalin® or pemoline for their fatigue 2. Major depression |
| Date of first enrolment | 15/09/2011 |
| Date of final enrolment | 01/04/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
VU University Medical Center (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Dept Rehabilitation Medicine
PO Box 7057
Amsterdam
1007 MB
Netherlands
| Website | http://www.vumc.com/patientcare/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Government
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ZonMw 60-61300-98-024)
No information available
Fonds NutsOhra (Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- NutsOhra Foundation, NutsOhra Fund, Stichting Nuts Ohra
- Location
- Netherlands
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/08/2013 | Yes | No | |
| Results article | results | 01/01/2015 | Yes | No |
