Effects of a Personalized Physical Training to Reduce Fatigue

NCT ID: NCT05899595

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-27
• Study Completion Date: 2027-11-08

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.

Conditions

Fatigue Syndrome, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise protocol

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Exercise protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire Interuniversitaire de Biologie de la Motricité

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David HUPIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Centre Hospitalier de Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David HUPIN, MD

Role: CONTACT

david.hupin@chu-st-etienne.fr

(0)477127985 ext. +33

Arnauld GARCIN, CRA

Role: CONTACT

Arnauld.Garcin@chu-st-etienne.fr

(0)477128286 ext. +33

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

23CH091

Identifier Type: -

Identifier Source: org_study_id