Treatment Of chronic Fatigue in patients with multiple sclerosis by paramedical disciplines
| ISRCTN | ISRCTN05017507 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05017507 |
| Protocol serial number | 04-553 MS |
| Sponsor | Stichting MS Research (Netherlands) |
| Funder | Stichting MS Research (Netherlands) (project number 04-553 MS) |
- Submission date
- 10/07/2013
- Registration date
- 05/08/2013
- Last edited
- 19/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Fatigue is a common and disabling symptom in people with multiple sclerosis (MS), and is considered to be one of the main causes of reduced daily activities and quality of life. Due to the multidimensional character of fatigue in MS it seems obvious to manage fatigue in a tailored, multidisciplinary way. To optimize the management of chronic fatigue in MS, a paramedical multidisciplinary rehabilitation program has been developed. The study's findings should help to optimize the management of fatigue in people with MS.
Who can participate?
The study aims to recruit 48 patients diagnosed with MS and suffering from chronic fatigue.
What does the study involve?
The patients will be randomly allocated to either receive multidisciplinary rehabilitation or a consultation with the MS nurse. Multidisciplinary rehabilitation consists of occupational therapy, physical therapy or social work or any combination of these treatments. Participants who are allocated to the MS nurse consultation are offered the opportunity to receive multidisciplinary rehabilitation once the study is completed.
What are the possible benefits and risks of participating?
Both interventions may have a positive effect on dealing with fatigue in MS, of which the effect of multidisciplinary rehabilitation is expected to be larger. Information obtained from this study may be beneficial for future fatigue management of people with MS suffering from fatigue. No harmful effects are expected for either treatment.
Where is the study run from?
The study was set up by the multidisciplinary care team of the MS centre Amsterdam, VU University Medical Centre Amsterdam.
When is the study starting and how long is it expected to run for?
Patient were recruited between February 2006 and November 2010.
Who is funding the study?
Stichting MS Research, Netherlands.
Who is the main contact?
Dr M. Rietberg, m.rietberg@vumc.nl
Professor Dr. G. Kwakkel
Contact information
Scientific
Department of Rehabilitation Medicine
VU University Medical Center
Amsterdam
1081 HV
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre single blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of multidisciplinary paramedic rehabilitation on chronic fatigue in multiple sclerosis: A randomised controlled trial |
| Study acronym | TOF |
| Study objectives | It is hypothesized that individually tailored, multidisciplinary outpatient rehabilitation by paramedical disciplines is more effective in reducing MS related chronic fatigue than consultation by an MS-nurse alone. |
| Ethics approval(s) | The RCT was approved by the ethics committee of the VU University Medical Centre, Amsterdam (METc VUmc). Registration number 2005/72. date 12-05-2005 |
| Health condition(s) or problem(s) studied | Multiple sclerosis, fatigue |
| Intervention | Multidisciplinary paramedical rehabilitation. Patients assigned to multidisciplinary rehabilitation receive either occupational therapy, physical therapy or social work or any combination of these treatments. The participating disciplines treat MS-related fatigue according to specific treatment programmes. MS-Nurse consultation Patients allocated to the control group receive MSnurse consultation based on the Nursing Intervention Classification (NIC) Double baseline assessment at week -1 and week 0, one assessment post intervention at 12 weeks and a follow-up assessment at 24 weeks. |
| Intervention type | Other |
| Primary outcome measure(s) |
Fatigue assessed using the self report questionnaire Checklist individual strength (CIS-20R): 20 statements for which the participant has to indicate on a 7 point scale ranging from Yes, that is true to No, that is not true to what extent the particular statement applies to him or her, at baseline, 12 weeks and 24 weeks. |
| Key secondary outcome measure(s) |
1. Modified Fatigue Impact Scale (MFIS): assesses the perceived impact of fatigue on the subscales physical, cognitive and psychosocial functioning during the past 4 weeks. Participants rate on a 5-point Likert scale, ranging from Never to Almost always, their agreement with 21 statements. |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 48 |
| Key inclusion criteria | 1. Age > 18 years, either sex 2. Diagnosed with MS according to the criteria of McDonald [Mc Donald 2001] and 3. Suffering from chronic fatigue. Chronic fatigue was defined as being present for any amount of time on at least 50 percent of the days, for more than 6 weeks as agreed on by the Multiple Sclerosis Council for Clinical Practice Guidelines. |
| Key exclusion criteria | Patients were excluded in case of: 1. Current MS relapse 2. Pregnancy 3. Current inflammation (cystitis) 4. Alcohol or substance abuse 5. Physical conditions like muscle spasm or pain, or 6. Depressive symptomatology importantly contributing to fatigue |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1081 HV
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/09/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |