Fatigue Syndrome, Chronic Clinical Trial
— OFF2HEALTHOfficial 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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | November 8, 2027 |
Est. primary completion date | November 8, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier de Saint-Etienne | Saint-Etienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Laboratoire Interuniversitaire de Biologie de la Motricité |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Month 1, 4 |
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