Effects of a Personalized Physical Training to Reduce Fatigue

Fatigue Syndrome, Chronic Clinical Trial

— OFF2HEALTH  

Official title:

Effects of a Personalized Physical Training to Reduce Fatigue in Chronic Fatigue Patients: a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899595
• Other study ID #: 23CH091
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: November 8, 2027

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: David HUPIN, MD
• Phone: (0)477127985
• Email: david.hupin[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fatigue
• Fatigue Syndrome, Chronic

Intervention

Other:
• Exercise protocol
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.

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Laboratoire Interuniversitaire de Biologie de la Motricité

Country where clinical trial is conducted

France, 

Outcome

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