Fatigue Syndrome, ChronicOFF2HEALTHNCT05899595
Effects of a Personalized Physical Training to Reduce Fatigue
A study testing Exercise protocol in people with Fatigue Syndrome, Chronic, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Chronic fatigue (CF) is a pathological fatigue over at least 6 months, without improvement after rest or sleep. In primary care, it is the major complaint in 5 to 10% of the consultations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue Syndrome, Chronic
- What is being tested?
- Exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2023to 10 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18
- Men or women
- FACIT-F score ≤ 34
- Ability to walk during 10 minutes without stopping
- Ability to receive the Myocene® stimulation protocol
- Have given written consent
- Members or beneficiaries of a social security program
Who cannot join
- Contraindication to experimental procedures
- Important health issues that would compromise the participant security during the study
- Persistent atrial fibrillation or 2nd or 3rd degree atrioventricular block
- Currently participating in an other interventional study or having so in the past thirty days
- Patient is pregnant
- Patient is unable to give an informed consent
- Patient is deprived of liberty or under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Personalized Physical Training to Reduce Fatigue in Chronic Fatigue Patients: a Randomized Controlled Trial.
Chronic fatigue (CF) is a pathological fatigue over at least 6 months, without improvement after rest or sleep. In primary care, it is the major complaint in 5 to 10% of the consultations. Physical activity is an efficient therapy to help reducing this fatigue in addition to the improvement of muscular and cardiorespiratory functions. However, it remains little exploited. Yet the studies focus mainly on precise chronic pathologies with general trainings, without considering the fatigue status and reveal a large heterogeneity. Personalizing the physical training appears to be the next step in order to improve chronic fatigue patients care.
The objective of this study will be to investigate the relevance and the effects of a personalized physical training to reduce fatigue in chronic fatigue patients.
- Conditions
- Fatigue Syndrome, Chronic
- Being tested
- Exercise protocol
- Keywords
- Fatigue, Neuromuscular function, Personalized training, Physical capacity, Fatigue status
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise protocolOther
Patients will be randomly assigned to the PERSO or the RECO group. Each week, fatigue status of the patients will be assessed with four evaluations:
- Subjective fatigue (Rate of Fatigue scale)
- Heart rate variability with a holter ECG
- Muscle pain with a visual analogue scale
- Muscle fatigue with muscular electrical stimulations with the Myocene® The two first correspond to an aerobic fatigue score and the two latter to a muscle fatigue score.
The RECO group will perform aerobic and resistance exercises to reach the recommendations for patients with chronic pathologies, with a moderate intensity and an increasing volume.
The PERSO group will perform similar exercises as the RECO group but the training load will be adapted by changing the intensity (with the same volume as RECO) depending on the fatigue scores of the week. The aerobic fatigue score will set the load for the aerobic exercises and the muscle fatigue score for the resistance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Personalized training group with the fatigue status (PERSO) | Experimental | The PERSO group will perform similar exercises as the RECO group but the training load will be adapted by changing the intensity (with the same volume as RECO) depending on the fatigue scores of the week. The aerobic fatigue score will set the load for the aerobic exercises and the muscle fatigue score for the resistance exercises. Receives: Other: Exercise protocol |
| Traditional training group following the recommendations (RECO) | Active comparator | The RECO group will perform aerobic and resistance exercises to reach the recommendations for patients with chronic pathologies, with a moderate intensity and an increasing volume. Receives: Other: Exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in the FACIT-F score obtained before and after the exercise procedure.
The FACIT-F (Functional Assessment of Chronic Illness Therapy) is a short questionnaire consisting of 13 questions which the patient answers on a scale of 0 to 4. The scores are simply added together, inverting the scale for negative sentences, to give a result out of 52 points. The lower the score, the greater the fatigue.
Measured: Month 1, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start27 Sep 2023
- Primary completion17 Dec 2025
- Study completion10 Apr 2026
Why it stopped: end of thesis funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Syndrome, ChronicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Interuniversitaire de Biologie de la Motricité
- Responsible party
- Sponsor
- Investigators
- David HUPIN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899595
- Sponsor's protocol ID
- 23CH091
- Other IDs
- ANSM
- Acronym
- OFF2HEALTH
- Status last verified
- May 2026
- First submitted
- 2 Jun 2023
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Personalized Physical Training to Reduce Fatigue in Chronic Fatigue Patients: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05899595
- Acronym / sponsor ID
- OFF2HEALTH / 23CH091
- Conditions
- Fatigue Syndrome, Chronic
- Keywords
- Fatigue, Neuromuscular function, Personalized training, Physical capacity, Fatigue status
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of thesis funding
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Laboratoire Interuniversitaire de Biologie de la Motricité
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 12 Jun 2023 (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.
Chronic fatigue (CF) is a pathological fatigue over at least 6 months, without improvement after rest or sleep. In primary care, it is the major complaint in 5 to 10% of the consultations. Physical activity is an efficient therapy to help reducing this fatigue in addition to the improvement of muscular and cardiorespiratory functions. However, it remains little exploited. Yet the studies focus mainly on precise chronic pathologies with general trainings, without considering the fatigue status and reveal a large heterogeneity. Personalizing the physical training appears to be the next step in order to improve chronic fatigue patients care.
The objective of this study will be to investigate the relevance and the effects of a personalized physical training to reduce fatigue in chronic fatigue patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized training group with the fatigue status (PERSO) | Experimental | Other: Exercise protocolThe PERSO group will perform similar exercises as the RECO group but the training load will be adapted by changing the intensity (with the same volume as RECO) depending on the fatigue scores of the week. The aerobic fatigue score will set the load for the aerobic exercises and the muscle fatigue score for the resistance exercises. |
| Traditional training group following the recommendations (RECO) | Active comparator | Other: Exercise protocolThe RECO group will perform aerobic and resistance exercises to reach the recommendations for patients with chronic pathologies, with a moderate intensity and an increasing volume. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥ 18
- Men or women
- FACIT-F score ≤ 34
- Ability to walk during 10 minutes without stopping
- Ability to receive the Myocene® stimulation protocol
Key exclusion criteria (7 listed)
- Contraindication to experimental procedures
- Important health issues that would compromise the participant security during the study
- Persistent atrial fibrillation or 2nd or 3rd degree atrioventricular block
- Currently participating in an other interventional study or having so in the past thirty days
- Patient is pregnant
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 |
|---|---|---|
| Exercise protocolPatients will be randomly assigned to the PERSO or the RECO group. Each week, fatigue status of the patients will be assessed with four evaluations: * Subjective fatigue (Rate of Fatigue scale) * Heart rate variability with a holter ECG * Muscle pain with a visual analogue scale * Muscle fatigue with muscular electrical stimulations with the Myocene® The two first correspond to an aerobic fatigue score and the two latter to a muscle fatigue score. The RECO group will perform aerobic and resistance exercises to reach the recommendations for patients with chronic pathologies, with a moderate intensity and an increasing volume. The PERSO group will perform similar exercises as the RECO group but the training load will be adapted by changing the intensity (with the same volume as RECO) depending on the fatigue scores of the week. The aerobic fatigue score will set the load for the aerobic exercises and the muscle fatigue score for the resistance exercises. | Other | Personalized training group with the fatigue status (PERSO), Traditional training group following the recommendations (RECO) |
Primary outcome
The primary outcome is the change in the FACIT-F score obtained before and after the exercise procedure.
Time frame: Month 1, 4
The FACIT-F (Functional Assessment of Chronic Illness Therapy) is a short questionnaire consisting of 13 questions which the patient answers on a scale of 0 to 4. The scores are simply added together, inverting the scale for negative sentences, to give a result out of 52 points. The lower the score, the greater the fatigue.
Results and safety
The study was stopped early (reason given: end of thesis funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- 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.
David HUPIN, MD 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 Exercise protocol in people with Fatigue Syndrome, Chronic, 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 7 inclusion and 7 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 8 May 2026. 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: end of thesis funding). 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?
The primary outcome is the change in the FACIT-F score obtained before and after the exercise procedure. (time frame: Month 1, 4). 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 8 May 2026.