Multiple SclerosisRE-SEPNCT02848976
Re-training to Effort (RE) According to the Severity of Multiple Sclerosis: Preliminary Assessments Based on Fatigue and Quality of Life
An observational study of Multiple Sclerosis, run by Nantes University Hospital at 1 site in France.
Trial summary
Regular physical activity promotes physical and mental well-being in the general population. Patients with multiple sclerosis (MS patients) tend them, to limit their physical activity or because of deficiencies related to the disease, or even on the advice of their caregivers in order to save their functional… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Re-training to effort (RE)
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to May 2010
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Due to the double question about the expected benefits of our CR program, the inclusion of patients was conducted in two distinct periods, from specialized MS consultations in the services of Neurology and Physical Medicine and Rehabilitation ( MPR) of the University Hospital of Nantes (France). The first period (I) would lead to compare patients with EDSS less than 6 performing an exercise training (retrained group = IA) and patients with similar levels of EDSS not engaged in physical training (not retrained group = IB). The second period (II) compared to patients EDSS between 6 and 8 (EDSS group high = IIA) and patients with lower EDSS (EDSS group IIB = low), the two groups were following a RE program.
Who may be able to join
- Patients necessarily declare fatigue perceived as annoying in everyday life.
- Basic electrocardiogram should be absolutely normal.
- Patients should subject themselves to regular participation in the RE program
Who cannot join
- In the previous month the inclusion or during the RE, the MS patients should not have presented thrust nor undergone intravenous chemotherapy, or have been in care center.
- Free of cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Regular physical activity promotes physical and mental well-being in the general population. Patients with multiple sclerosis (MS patients) tend them, to limit their physical activity or because of deficiencies related to the disease, or even on the advice of their caregivers in order to save their functional abilities. Time for leisure activity could be almost 20% lower in MS patients compared to healthy controls, and this situation is likely to aggravate the functional symptoms of multiple sclerosis.
The literature described the benefit of physical activity for MS patients according to protocols and varied assessments. Evaluations were indeed concern very analytical elements of metabolic functioning, nervous, muscular, cardiopulmonary etc ... or take into account the performance of components or fatigue and quality of life. Due to the multiplicity of RE protocols, sometimes on the verge of pragmatic goals of functional rehabilitation, the double issue was the profit earned by an RE program and of this benefit by level of severity of MS. The main objective of our study was an evaluation of the effects on fatigue and quality of life of a retraining program to effort suitable for levels of impairment and patients with MS activity limitations. The secondary objective was checking a performance improvement of the patients in this adapted program.
- Conditions
- Multiple Sclerosis
- Being tested
- Re-training to effort (RE)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-training to effort (RE)Other
The RE program includes three weekly sessions, supervised individually by a teacher in adapted physical activity, during 1:30, for four weeks, for a total of 12 sessions
| Study group | Role | What they receive |
|---|---|---|
| IA group | EDSS (Expanded Disability Status Scale) below 6 with RE Receives: Other: Re-training to effort (RE) | |
| IB group | EDSS (Expanded Disability Status Scale) below 6 with no RE | |
| IIA group | EDSS (Expanded Disability Status Scale) betwin 6 and 8 with RE Receives: Other: Re-training to effort (RE) | |
| IIB group | EDSS (Expanded Disability Status Scale) below 6 with RE Receives: Other: Re-training to effort (RE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEP-59 questionnaire in MS
The first main criteria was established by the link between the quality of life (SEP-59 self-questionnaire scores) and the specific numerical data of multiple sclerosis
Measured: 1 month
Scale impact of fatigue in MS (EMIF-SEP)
The second main criteria was established by the link between the fatigue (scale impact of fatigue in MS (EMIF-SEP), self-questionnaire scores) and the specific numerical data of multiple sclerosis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJan 2009
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc LE FORT, Doctor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848976
- Sponsor's protocol ID
- RC13_0296
- Acronym
- RE-SEP
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-training to Effort (RE) According to the Severity of Multiple Sclerosis: Preliminary Assessments Based on Fatigue and Quality of Life
- ClinicalTrials.gov ID
- NCT02848976
- Acronym / sponsor ID
- RE-SEP / RC13_0296
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regular physical activity promotes physical and mental well-being in the general population. Patients with multiple sclerosis (MS patients) tend them, to limit their physical activity or because of deficiencies related to the disease, or even on the advice of their caregivers in order to save their functional abilities. Time for leisure activity could be almost 20% lower in MS patients compared to healthy controls, and this situation is likely to aggravate the functional symptoms of multiple sclerosis.
The literature described the benefit of physical activity for MS patients according to protocols and varied assessments. Evaluations were indeed concern very analytical elements of metabolic functioning, nervous, muscular, cardiopulmonary etc ... or take into account the performance of components or fatigue and quality of life. Due to the multiplicity of RE protocols, sometimes on the verge of pragmatic goals of functional rehabilitation, the double issue was the profit earned by an RE program and of this benefit by level of severity of MS. The main objective of our study was an evaluation of the effects on fatigue and quality of life of a retraining program to effort suitable for levels of impairment and patients with MS activity limitations. The secondary objective was checking a performance improvement of the patients in this adapted program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IA group | – | Other: Re-training to effort (RE)EDSS (Expanded Disability Status Scale) below 6 with RE |
| IB group | – | –EDSS (Expanded Disability Status Scale) below 6 with no RE |
| IIA group | – | Other: Re-training to effort (RE)EDSS (Expanded Disability Status Scale) betwin 6 and 8 with RE |
| IIB group | – | Other: Re-training to effort (RE)EDSS (Expanded Disability Status Scale) below 6 with RE |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Due to the double question about the expected benefits of our CR program, the inclusion of patients was conducted in two distinct periods, from specialized MS consultations in the services of Neurology and Physical Medicine and Rehabilitation ( MPR) of the University Hospital of Nantes (France). The first period (I) would lead to compare patients with EDSS less than 6 performing an exercise training (retrained group = IA) and patients with similar levels of EDSS not engaged in physical training (not retrained group = IB). The second period (II) compared to patients EDSS between 6 and 8 (EDSS group high = IIA) and patients with lower EDSS (EDSS group IIB = low), the two groups were following a RE program.
Key inclusion criteria (3 listed)
- Patients necessarily declare fatigue perceived as annoying in everyday life.
- Basic electrocardiogram should be absolutely normal.
- Patients should subject themselves to regular participation in the RE program
Key exclusion criteria (2 listed)
- In the previous month the inclusion or during the RE, the MS patients should not have presented thrust nor undergone intravenous chemotherapy, or have been in care center.
- Free of cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-training to effort (RE)The RE program includes three weekly sessions, supervised individually by a teacher in adapted physical activity, during 1:30, for four weeks, for a total of 12 sessions | Other | IA group, IIA group, IIB group |
Primary outcome
SEP-59 questionnaire in MS
Time frame: 1 month
The first main criteria was established by the link between the quality of life (SEP-59 self-questionnaire scores) and the specific numerical data of multiple sclerosis
Scale impact of fatigue in MS (EMIF-SEP)
Time frame: 1 month
The second main criteria was established by the link between the fatigue (scale impact of fatigue in MS (EMIF-SEP), self-questionnaire scores) and the specific numerical data of multiple sclerosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc LE FORT, Doctor principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SEP-59 questionnaire in MS (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.