SclerosisMovelySEPNCT06201026
Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis
A study testing Traditional exercise and Individualized exercise in people with Sclerosis and Fatigue, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms. Chronic fatigue is the most reported symptom in MS patients (80%). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Traditional exercise and Individualized exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2023to 15 Sep 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Relapsing-remitting MS (RRMS) defined according to the criteria of McDonald
- MS diagnosed less than 2 years ago or whose first symptoms are estimated to be less than 5 years old OR MS diagnosed more than 2 years ago and whose first symptoms are estimated to be less than 5 years old
- With a high level of fatigue, corresponding to an FSS score > 4
- Expanded Disability Status Scale (EDSS) score < 4
- Medical Research Council (MRC) testing ≥ 4 in all leg muscles
- Ability to walk for 10 minutes without stopping (self-reported)
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- Have a mobile phone with internet access
- Affiliated with or benefiting from a social security scheme
- Have freely given their written consent after being informed of the aim, the procedure and the potential risks involved
Who cannot join
- Spasticity or severe cerebellar ataxia in either leg.
- Abnormal range of movement of the toes and/or ankle
- Musculoskeletal injury that impairs pedalling
- Appearance of a multiple sclerosis attack in the 90 days preceding the study
- Recent adjustment of any medication or drug that may have an impact on fatigue: treatment of neuropathic pain: anti-epileptic and/or taking stimulants for fatigue (e.g. modafinil, amantadine, fampridine...)
- History of comorbid illness or conditions that would compromise the subject's safety during the study
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- Participation at the same time in another medical intervention study or having participated in such a study in the 30 days prior to this study
- Pregnant and breast-feeding women
- Patients who are unable to understand the purpose of the study and the conditions under which it will be conducted, or who are unable to give their consent.
- Patients deprived of their liberty or under guardianship
Trial locations and contacts
1 site in 1 country.
Jean-Philippe CAMDESSANCHE, PHD contact
France1 site, 1 recruiting
- Recruiting
Chu de Saint-Etienne
Saint-Etienne, 42055
JEAN-PHILIPPE CAMDESSANCHE, PHD, (4)77120559, j.philippe.camdessanche@chu-st-etienne.fr
About this study
Official title: Effects of Individualized, Home-based, Mobile App-guided Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis: a Randomized Controlled Trial.
Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms. Chronic fatigue is the most reported symptom in MS patients (80%). Current pharmacological treatments for MS patients reduce the number of relapses and their severity but do not improve symptoms such as fatigue. Physical activity is a therapy that helps reduce this fatigue, in addition to improving muscular and cardiorespiratory functions. However, the results are not optimal because MS patients remain less active than the general population. The improvement of the benefits of exercise therapy could therefore be based on three approaches: personalization of the training program, home practice and early initiation.
Read the detailed description
The objective of this study will be to investigate the effects of individualized home-training, guided by a mobile application, to reduce fatigue in patients with newly (N) and advanced (A) diagnosed MS.
- Being tested
- Traditional exercise, Individualized exercise
- Keywords
- Fatigue, Neuromuscular function, Muscle characteristics, Physical capacity
- Medical subject headings
- Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional exerciseOther
Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home
Individualized exerciseOther
Patients will performed a mobile-app guided program at home designed to address identified individual disabilities such as loss of muscle strength or cardiorespiratory deconditioning.
| Study group | Role | What they receive |
|---|---|---|
| Traditional exercise group in newly diagnosed patients with MS (SEP-R-TEM) | Active comparator | Newly diagnosed patients with MS who will be part of the group doing traditional exercises Receives: Other: Traditional exercise |
| Individualized exercise group in newly diagnosed patients with MS (SEP-R-IND) | Experimental | Newly diagnosed patients with MS who will be part of the group doing individualized exercises Receives: Other: Individualized exercise |
| Traditional exercise group in advanced diagnosed patients with MS (SEP-A-TEM) | Active comparator | Advanced diagnosed patients with MS who will be part of the group doing traditional exercises Receives: Other: Traditional exercise |
| Individualized exercise group in advanced diagnosed patients with MS (SEP-A-IND) | Experimental | Advanced diagnosed patients with MS who will be part of the group doing individualized exercises. Receives: Other: Individualized exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale (FSS)
Change in the chronic fatigue score assessed using the FSS questionnaire before and after the training programme. From 1 to 7.
The higher the score, the greater the fatigue
Measured: Week 15
Secondary outcomes (12)
cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies
ONLY FOR MS-N PATIENTS
Measured: Week 17
Muscle enzymatic activity (UI)
ONLY FOR MS-N PATIENTS
The enzymatic activity is measured for the following enzymes :
- Phosphofructokinase (PFK)
- lactate dehydrogenase (LDH)
- citrate synthase (CS)
- cyclo-oxygenase (COx)
Enzymatic activity is measured in units international (UI) It indicates the rate of enzymatic reaction catalyzed by the enzyme, expressed in micromoles of substrate transformed (or product formed) per minute.
Measured: Week 17
Maximal oxygen uptake (VO2max) (ml/min)
Cardiac stress test
Measured: Week 15
Percentage of voluntary activation (%)
Voluntary Activation of the extensor muscles of the knee by peripheral nerve stimulation
Measured: Week 16
C-reactive protein (CRP) (mg/l)
Blood sample
Measured: Week 15
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle
Measured: Week 16
Maximal voluntary contraction (MVC) of the hand grip measurement
Measured: Week 16
Balance test (s)
This test, performed in unipedal support, consists of asking the subject to hold the unipedal position for as long as possible, on the lower limb of his choice.
Measured: Week 16
Quality of life questionnaire (SEP-59)
Scale from 0 (worst quality of life) to 100 (best quality of life)
Measured: Week 15
Epworth score
From 0 to 24
The higher the score, the greater the degree of drowsiness
Measured: Week 15
Pittsburgh Sleep Quality Index (PSQI)
From 0 to 21 The higher the score, the worse the quality of sleep
Measured: Week 15
Hospital Anxiety and Depression scale (HAD)
From 0 to 42 The higher the score, the greater the anxiety and depression
Measured: Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start12 Sep 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe CAMDESSANCHE, PHD, Principal investigator, CHU DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201026
- Sponsor's protocol ID
- 23CH024
- Other IDs
- ANSM
- Acronym
- MovelySEP
- Status last verified
- Oct 2024
- First submitted
- 12 Dec 2023
- Last updated
- 23 Oct 2024
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized, Home-based, Mobile App-guided Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06201026
- Acronym / sponsor ID
- MovelySEP / 23CH024
- Keywords
- Fatigue, Neuromuscular function, Muscle characteristics, Physical capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 11 Jan 2024 (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.
Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms. Chronic fatigue is the most reported symptom in MS patients (80%). Current pharmacological treatments for MS patients reduce the number of relapses and their severity but do not improve symptoms such as fatigue. Physical activity is a therapy that helps reduce this fatigue, in addition to improving muscular and cardiorespiratory functions. However, the results are not optimal because MS patients remain less active than the general population. The improvement of the benefits of exercise therapy could therefore be based on three approaches: personalization of the training program, home practice and early initiation.
Detailed description
The objective of this study will be to investigate the effects of individualized home-training, guided by a mobile application, to reduce fatigue in patients with newly (N) and advanced (A) diagnosed MS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traditional exercise group in newly diagnosed patients with MS (SEP-R-TEM) | Active comparator | Other: Traditional exerciseNewly diagnosed patients with MS who will be part of the group doing traditional exercises |
| Individualized exercise group in newly diagnosed patients with MS (SEP-R-IND) | Experimental | Other: Individualized exerciseNewly diagnosed patients with MS who will be part of the group doing individualized exercises |
| Traditional exercise group in advanced diagnosed patients with MS (SEP-A-TEM) | Active comparator | Other: Traditional exerciseAdvanced diagnosed patients with MS who will be part of the group doing traditional exercises |
| Individualized exercise group in advanced diagnosed patients with MS (SEP-A-IND) | Experimental | Other: Individualized exerciseAdvanced diagnosed patients with MS who will be part of the group doing individualized exercises. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Relapsing-remitting MS (RRMS) defined according to the criteria of McDonald
- MS diagnosed less than 2 years ago or whose first symptoms are estimated to be less than 5 years old OR MS diagnosed more than 2 years ago and whose first symptoms are estimated to be less than 5 years old
- With a high level of fatigue, corresponding to an FSS score > 4
- Expanded Disability Status Scale (EDSS) score < 4
- Medical Research Council (MRC) testing ≥ 4 in all leg muscles
Key exclusion criteria (10 listed)
- Spasticity or severe cerebellar ataxia in either leg.
- Abnormal range of movement of the toes and/or ankle
- Musculoskeletal injury that impairs pedalling
- Appearance of a multiple sclerosis attack in the 90 days preceding the study
- Recent adjustment of any medication or drug that may have an impact on fatigue: treatment of neuropathic pain: anti-epileptic and/or taking stimulants for fatigue (e.g. modafinil, amantadine, fampridine...)
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 |
|---|---|---|
| Traditional exercisePatients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home | Other | Traditional exercise group in advanced diagnosed patients with MS (SEP-A-TEM), Traditional exercise group in newly diagnosed patients with MS (SEP-R-TEM) |
| Individualized exercisePatients will performed a mobile-app guided program at home designed to address identified individual disabilities such as loss of muscle strength or cardiorespiratory deconditioning. | Other | Individualized exercise group in advanced diagnosed patients with MS (SEP-A-IND), Individualized exercise group in newly diagnosed patients with MS (SEP-R-IND) |
Primary outcome
Fatigue Severity Scale (FSS)
Time frame: Week 15
Change in the chronic fatigue score assessed using the FSS questionnaire before and after the training programme. From 1 to 7. The higher the score, the greater the fatigue
12 secondary outcomes
cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies
Time frame: Week 17
Muscle enzymatic activity (UI)
Time frame: Week 17
Maximal oxygen uptake (VO2max) (ml/min)
Time frame: Week 15
Percentage of voluntary activation (%)
Time frame: Week 16
C-reactive protein (CRP) (mg/l)
Time frame: Week 15
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement
Time frame: Week 16
Maximal voluntary contraction (MVC) of the hand grip measurement
Time frame: Week 16
Balance test (s)
Time frame: Week 16
Quality of life questionnaire (SEP-59)
Time frame: Week 15
Epworth score
Time frame: Week 15
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 15
Hospital Anxiety and Depression scale (HAD)
Time frame: Week 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- 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, PHD contact
Jean-Philippe CAMDESSANCHE, PHD principal investigator
CHU 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 Traditional exercise and Individualized exercise in people with Sclerosis and Fatigue, 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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Philippe CAMDESSANCHE, PHD ((4)77120559 ext. +33, j.phillippe.camdessanche@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (FSS) (time frame: Week 15). 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 23 Oct 2024.