Multiple SclerosisREEN-SEPNCT04796272
Role of Individualized Versus Traditional Exercise in Combating Fatigue
A study testing Adapted and individualized physical training program and traditional training program in people with Multiple Sclerosis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Adapted and individualized physical training program and traditional training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2021to 30 Jun 2022
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years old
- Male or female
- With relapsing-remitting multiple sclerosis (RRMS) as defined by McDonald's 2010 criteria.
- Between 2 and 25 years from the onset of multiple sclerosis
- With a high level of fatigue, corresponding to a score of Fatigue Severity Scale> 4 and Fatigue questionnaire > 38.
- Expanded Disability Status Scale Score 5
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- Testing ≥ 4 in all leg muscles.
- Ability to walk for 10 minutes without stopping (self-reported)
- Affiliates or beneficiaries of a social security scheme
- Having freely given their written consent after having been informed of the purpose, course of action and potential risks involved
Who cannot join
- Severe cerebellar spasticity or ataxia in either leg.
- Abnormal range of motion of the toes and/or ankle.
- Musculoskeletal injury that interferes with pedaling.
- High resting heart rate (>90 beats per minute).
- Blood pressure > 144/94 mmHg.
- Onset of a multiple sclerosis attack within 90 days prior to the study.
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- Recent adjustment of any medication or drugs that may impact on fatigue, or taking stimulants for fatigue (e.g. Modafinil).
- Taking of neuro-active substances that may impair cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) throughout the study period.
- Contraindication to the application of a magnetic field
- History of co-morbid disease or conditions that would compromise the subject's safety during the study.
- Participation at the same time in another medical intervention study or having participated in such a study within 30 days prior to this study.
- Pregnant and Nursing Women
- Women of childbearing age without effective contraception
- Patient unable to understand the purpose and conditions of the study, incapable of giving consent
- Patient deprived of liberty or patient under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients
The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.
Read the detailed description
Chronic fatigue is a very common symptom reported (80%) by patients with multiple sclerosis (MS), regardless of the type of MS and level of disability. Despite the clinical importance of MS-related fatigue, pharmacological treatments remain quite ineffective in preventing or treating chronic fatigue.
Recently, physical activity has proven to be an effective therapy with benefits on chronic fatigue as well as on different functions (muscular, cardiorespiratory, cognitive, etc.). Nevertheless, the effects of physical exercise may vary between MS patients, as MS is a heterogeneous disease and does not affect each individual in the same way. The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Adapted and individualized physical training program, traditional training program
- Keywords
- multiple sclerosis, individual exercise, fatigue, traditional exercise
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted and individualized physical training programOther
Physical training program adapted and individualized according to each patient in this group
traditional training programOther
Same training program for all patients in this group
| Study group | Role | What they receive |
|---|---|---|
| Traditional exercise | Active comparator | fatigued multiple sclerosis patients with a traditional training program Receives: Other: traditional training program |
| Individual exercise | Experimental | tired multiple sclerosis patients with an adapted and individualized training program Receives: Other: Adapted and individualized physical training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic fatigue score
assessed using the Fatigue Severity Scale (FSS) questionnaire before and after an individualized re-training program compared to a traditional re-training program in MS patients.
Measured: Month 3
Secondary outcomes (12)
cardiorespiratory fitness
evaluated by measuring the maximum oxygen consumption (VO2max) during an incremental exercise on a cycloergometer.
Measured: Month 3
Hematological parameters
red blood cell and hemoglobin levels measured by spectrophotometry.
Measured: Month 3
Inflammatory parameters
c-reactive protein
Measured: Month 3
quality of sleep
actigraphy measurements and sleep diary records
Measured: Month 3
cortical activation level
transcranial magnetic stimulation
Measured: Month 3
cortico-spinal excitability
transcranial magnetic stimulation
Measured: Month 3
neuromuscular fatigue of peripheral function
electrical nerve stimulation
Measured: Month 3
Analysis overall quality of life : Fatigue questionnaire
Fatigue questionnaire by Modified Fatigue Impact Scale (MFIS) results
Measured: Month 3
Analysis overall quality of life :Quality of Life
Quality of Life Questionnaire by SEP-59 results
Measured: Month 3
Analysis overall quality of life :Depression
Depression Questionnaire by Center for Epidemiologic Studies Depression (CES-D) results
Measured: Month 3
Analysis overall quality of life : Sleep Quality
Sleep Quality Questionnaire by Pittsburgh Sleep Quality Index (PSQ-I) results
Measured: Month 3
Analysis overall quality of life : Physical Activity
Physical Activity Questionnaire by Godin Leisure-Time Exercise Questionnaire (GLTEQ) results
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start2 Apr 2021
- Primary completion23 Feb 2022
- Study completion30 Jun 2022
Why it stopped: low inclusion rates
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 Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Philippe CAMDESSANCHE, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796272
- Sponsor's protocol ID
- 20CH032
- Other IDs
- 2020-A00841-38
- Acronym
- REEN-SEP
- Status last verified
- Oct 2023
- First submitted
- 15 Jan 2021
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04796272
- Acronym / sponsor ID
- REEN-SEP / 20CH032
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, individual exercise, fatigue, traditional exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low inclusion rates
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Mar 2021 (actual)
- 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.
The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.
Detailed description
Chronic fatigue is a very common symptom reported (80%) by patients with multiple sclerosis (MS), regardless of the type of MS and level of disability. Despite the clinical importance of MS-related fatigue, pharmacological treatments remain quite ineffective in preventing or treating chronic fatigue.
Recently, physical activity has proven to be an effective therapy with benefits on chronic fatigue as well as on different functions (muscular, cardiorespiratory, cognitive, etc.). Nevertheless, the effects of physical exercise may vary between MS patients, as MS is a heterogeneous disease and does not affect each individual in the same way. The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional exercise | Active comparator | Other: traditional training programfatigued multiple sclerosis patients with a traditional training program |
| Individual exercise | Experimental | Other: Adapted and individualized physical training programtired multiple sclerosis patients with an adapted and individualized training program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 to 70 years old
- Male or female
- With relapsing-remitting multiple sclerosis (RRMS) as defined by McDonald's 2010 criteria.
- Between 2 and 25 years from the onset of multiple sclerosis
- With a high level of fatigue, corresponding to a score of Fatigue Severity Scale> 4 and Fatigue questionnaire > 38.
Key exclusion criteria (15 listed)
- Severe cerebellar spasticity or ataxia in either leg.
- Abnormal range of motion of the toes and/or ankle.
- Musculoskeletal injury that interferes with pedaling.
- High resting heart rate (>90 beats per minute).
- Blood pressure > 144/94 mmHg.
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 |
|---|---|---|
| Adapted and individualized physical training programPhysical training program adapted and individualized according to each patient in this group | Other | Individual exercise |
| traditional training programSame training program for all patients in this group | Other | Traditional exercise |
Primary outcome
Chronic fatigue score
Time frame: Month 3
assessed using the Fatigue Severity Scale (FSS) questionnaire before and after an individualized re-training program compared to a traditional re-training program in MS patients.
12 secondary outcomes
cardiorespiratory fitness
Time frame: Month 3
Hematological parameters
Time frame: Month 3
Inflammatory parameters
Time frame: Month 3
quality of sleep
Time frame: Month 3
cortical activation level
Time frame: Month 3
cortico-spinal excitability
Time frame: Month 3
neuromuscular fatigue of peripheral function
Time frame: Month 3
Analysis overall quality of life : Fatigue questionnaire
Time frame: Month 3
Analysis overall quality of life :Quality of Life
Time frame: Month 3
Analysis overall quality of life :Depression
Time frame: Month 3
Analysis overall quality of life : Sleep Quality
Time frame: Month 3
Analysis overall quality of life : Physical Activity
Time frame: Month 3
Results and safety
The study was stopped early (reason given: low inclusion rates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- 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.
Jean Philippe CAMDESSANCHE, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted and individualized physical training program and traditional training program in people with Multiple Sclerosis, run by Centre Hospitalier Universitaire de Saint Etienne 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 10 inclusion and 15 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: stopped early, as of the sponsor's last update on 2 Nov 2023. 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 was stopped early (reason given: low inclusion rates). Results are not available in the source record.
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?
Chronic fatigue score (time frame: Month 3). 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 2 Nov 2023.