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

Primary Purpose

Fatigue Syndrome, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exercise protocol
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue Syndrome, Chronic focused on measuring Fatigue, Neuromuscular function, Personalized training, Physical capacity, Fatigue status

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier de Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized training group with the fatigue status (PERSO)

Traditional training group following the recommendations (RECO)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2023
Last Updated
October 12, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Laboratoire Interuniversitaire de Biologie de la Motricité
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1. Study Identification

Unique Protocol Identification Number
NCT05899595
Brief Title
Effects of a Personalized Physical Training to Reduce Fatigue
Acronym
OFF2HEALTH
Official Title
Effects of a Personalized Physical Training to Reduce Fatigue in Chronic Fatigue Patients: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2023 (Actual)
Primary Completion Date
November 8, 2027 (Anticipated)
Study Completion Date
November 8, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Laboratoire Interuniversitaire de Biologie de la Motricité

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue Syndrome, Chronic
Keywords
Fatigue, Neuromuscular function, Personalized training, Physical capacity, Fatigue status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized training group with the fatigue status (PERSO)
Arm Type
Experimental
Arm Description
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 Title
Traditional training group following the recommendations (RECO)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome is the change in the FACIT-F score obtained before and after the exercise procedure.
Description
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.
Time Frame
Month 1, 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David HUPIN, MD
Phone
(0)477127985
Ext
+33
Email
david.hupin@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Arnauld GARCIN, CRA
Phone
(0)477128286
Ext
+33
Email
Arnauld.Garcin@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David HUPIN, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David HUPIN, MD
First Name & Middle Initial & Last Name & Degree
Léonard FEASSON, MD PhD
First Name & Middle Initial & Last Name & Degree
Clément FOSCHIA, MD
First Name & Middle Initial & Last Name & Degree
Philippe BOIRON, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Personalized Physical Training to Reduce Fatigue

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