Effects of a Personalized Physical Training to Reduce Fatigue

Not Applicable

Recruiting

• Conditions: Fatigue Syndrome, Chronic
• Interventions: Other: Exercise protocol

• Registration Number: NCT05899595
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-12
• Status Verified: 2023-08
• Study Start: 2023-09-27
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13
• Primary Completion: 2027-11-08
• Study Completion: 2027-11-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized training group with the fatigue status (PERSO)	Exercise protocol	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.
Traditional training group following the recommendations (RECO)	Exercise protocol	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.

Primary Outcome Measures

Name	Time	Method
The primary outcome is the change in the FACIT-F score obtained before and after the exercise procedure.	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.

Trial Locations

Locations (1)

Centre Hospitalier de Saint-Etienne; 🇫🇷 Saint-Etienne, France