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Effects of a Personalized Physical Training to Reduce Fatigue

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05899595
Acronym
OFF2HEALTH
Enrollment
101
Registered
2023-06-12
Start date
2023-09-27
Completion date
2026-04-10
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue Syndrome, Chronic

Keywords

Fatigue, Neuromuscular function, Personalized training, Physical capacity, Fatigue status

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.

Interventions

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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER
Laboratoire Interuniversitaire de Biologie de la Motricité
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome is the change in the FACIT-F score obtained before and after the exercise procedure.Month 1, 4The 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORDavid HUPIN, MD

Centre Hospitalier Universitaire de Saint Etienne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026