OFF2HEALTH: Effects of a Personalized Physical Training to Reduce Fatigue

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05899595

Collaborator

Laboratoire Interuniversitaire de Biologie de la Motricité (Other)

130

Enrollment

Location

Arms

52.3

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue Syndrome, Chronic	Other: Exercise protocol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Nov 8, 2027

Anticipated Study Completion Date :

Nov 8, 2027

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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