Effects of a Personalized Physical Training to Reduce Fatigue

Study Overview
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Brief Summary
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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.

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

Conditions
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Fatigue Syndrome, Chronic

Intervention / Treatment
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* Other: Exercise protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized training group with the fatigue status (PERSO)<br>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: Exercise protocol<br>* 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.<br>|
| Active Comparator: Traditional training group following the recommendations (RECO)<br>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. | Other: Exercise protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Neuromuscular function, Personalized training, Physical capacity, Fatigue status