Effects of a Personalized Physical Training to Reduce Fatigue (OFF2HEALTH)

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.

Study Overview

• Status: Recruiting
• Conditions: Fatigue Syndrome, Chronic
• Intervention / Treatment: Other: Exercise protocol

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David HUPIN, MD; Phone Number: +33 (0)477127985; Email: david.hupin@chu-st-etienne.fr
• Study Contact Backup: Name: Arnauld GARCIN, CRA; Phone Number: +33 (0)477128286; Email: Arnauld.Garcin@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Recruiting
    • Centre Hospitalier de Saint-Etienne
    • Principal Investigator: David HUPIN, MD
    • Sub-Investigator: Léonard FEASSON, MD PhD
    • Sub-Investigator: Clément Foschia, MD
    • Sub-Investigator: Philippe BOIRON, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized training group with the fatigue status (PERSO); 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; 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.
Active Comparator: Traditional training group following the recommendations (RECO); 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Laboratoire Interuniversitaire de Biologie de la Motricité
• Investigators: Principal Investigator: David HUPIN, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): November 8, 2027
• Study Completion (Estimated): November 8, 2027

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Fatigue; Physical capacity; Neuromuscular function; Personalized training; Fatigue status
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: 23CH091; ANSM (Other Identifier: 2024-A00286-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No