Effects of a Personalized Physical Training to Reduce Fatigue

NCT05899595 | Recruiting

• 2 other identifiers: 23CH091ANSM
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Personalized training group with the fatigue status (PERSO)

EXPERIMENTAL

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

Traditional training group following the recommendations (RECO)

ACTIVE COMPARATOR

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

Interventions

Exercise protocol 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.

Personalized training group with the fatigue status (PERSO); Traditional training group following the recommendations (RECO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Laboratoire Interuniversitaire de Biologie de la Motricité: collaborator

Study Sites (1)

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Fatigue

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• David HUPIN, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David HUPIN, MD

CONTACT

(0)477127985; david.hupin@chu-st-etienne.fr

Arnauld GARCIN, CRA

CONTACT

(0)477128286; Arnauld.Garcin@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): November 8, 2027
• Study Completion (Estimated): November 8, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)