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Role of Individualized Versus Traditional Exercise in Combating Fatigue (REEN-SEP)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted and individualized physical training program
traditional training program
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Sclerosis focused on measuring multiple sclerosis, individual exercise, fatigue, traditional exercise

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 to 70 years old
  • Male or female
  • With relapsing-remitting multiple sclerosis (RRMS) as defined by McDonald's 2010 criteria.
  • Between 2 and 25 years from the onset of multiple sclerosis
  • With a high level of fatigue, corresponding to a score of Fatigue Severity Scale> 4 and Fatigue questionnaire > 38.
  • Expanded Disability Status Scale Score 5
  • Testing ≥ 4 in all leg muscles.
  • Ability to walk for 10 minutes without stopping (self-reported)
  • Affiliates or beneficiaries of a social security scheme
  • Having freely given their written consent after having been informed of the purpose, course of action and potential risks involved

Exclusion Criteria:

  • Severe cerebellar spasticity or ataxia in either leg.
  • Abnormal range of motion of the toes and/or ankle.
  • Musculoskeletal injury that interferes with pedaling.
  • High resting heart rate (>90 beats per minute).
  • Blood pressure > 144/94 mmHg.
  • Onset of a multiple sclerosis attack within 90 days prior to the study.
  • Recent adjustment of any medication or drugs that may impact on fatigue, or taking stimulants for fatigue (e.g. Modafinil).
  • Taking of neuro-active substances that may impair cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) throughout the study period.
  • Contraindication to the application of a magnetic field
  • History of co-morbid disease or conditions that would compromise the subject's safety during the study.
  • Participation at the same time in another medical intervention study or having participated in such a study within 30 days prior to this study.
  • Pregnant and Nursing Women
  • Women of childbearing age without effective contraception
  • Patient unable to understand the purpose and conditions of the study, incapable of giving consent
  • Patient deprived of liberty or patient under guardianship

Sites / Locations

  • CHU de Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional exercise

Individual exercise

Arm Description

fatigued multiple sclerosis patients with a traditional training program

tired multiple sclerosis patients with an adapted and individualized training program

Outcomes

Primary Outcome Measures

Chronic fatigue score
assessed using the Fatigue Severity Scale (FSS) questionnaire before and after an individualized re-training program compared to a traditional re-training program in MS patients.

Secondary Outcome Measures

cardiorespiratory fitness
evaluated by measuring the maximum oxygen consumption (VO2max) during an incremental exercise on a cycloergometer.
Hematological parameters
red blood cell and hemoglobin levels measured by spectrophotometry.
Inflammatory parameters
c-reactive protein
quality of sleep
actigraphy measurements and sleep diary records
cortical activation level
transcranial magnetic stimulation
cortico-spinal excitability
transcranial magnetic stimulation
neuromuscular fatigue of peripheral function
electrical nerve stimulation
Analysis overall quality of life : Fatigue questionnaire
Fatigue questionnaire by Modified Fatigue Impact Scale (MFIS) results
Analysis overall quality of life :Quality of Life
Quality of Life Questionnaire by SEP-59 results
Analysis overall quality of life :Depression
Depression Questionnaire by Center for Epidemiologic Studies Depression (CES-D) results
Analysis overall quality of life : Sleep Quality
Sleep Quality Questionnaire by Pittsburgh Sleep Quality Index (PSQ-I) results
Analysis overall quality of life : Physical Activity
Physical Activity Questionnaire by Godin Leisure-Time Exercise Questionnaire (GLTEQ) results

Full Information

First Posted
January 15, 2021
Last Updated
December 13, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT04796272
Brief Title
Role of Individualized Versus Traditional Exercise in Combating Fatigue
Acronym
REEN-SEP
Official Title
Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

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
The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.
Detailed Description
Chronic fatigue is a very common symptom reported (80%) by patients with multiple sclerosis (MS), regardless of the type of MS and level of disability. Despite the clinical importance of MS-related fatigue, pharmacological treatments remain quite ineffective in preventing or treating chronic fatigue. Recently, physical activity has proven to be an effective therapy with benefits on chronic fatigue as well as on different functions (muscular, cardiorespiratory, cognitive, etc.). Nevertheless, the effects of physical exercise may vary between MS patients, as MS is a heterogeneous disease and does not affect each individual in the same way. The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, individual exercise, fatigue, traditional exercise

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional exercise
Arm Type
Active Comparator
Arm Description
fatigued multiple sclerosis patients with a traditional training program
Arm Title
Individual exercise
Arm Type
Experimental
Arm Description
tired multiple sclerosis patients with an adapted and individualized training program
Intervention Type
Other
Intervention Name(s)
Adapted and individualized physical training program
Intervention Description
Physical training program adapted and individualized according to each patient in this group
Intervention Type
Other
Intervention Name(s)
traditional training program
Intervention Description
Same training program for all patients in this group
Primary Outcome Measure Information:
Title
Chronic fatigue score
Description
assessed using the Fatigue Severity Scale (FSS) questionnaire before and after an individualized re-training program compared to a traditional re-training program in MS patients.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
cardiorespiratory fitness
Description
evaluated by measuring the maximum oxygen consumption (VO2max) during an incremental exercise on a cycloergometer.
Time Frame
Month 3
Title
Hematological parameters
Description
red blood cell and hemoglobin levels measured by spectrophotometry.
Time Frame
Month 3
Title
Inflammatory parameters
Description
c-reactive protein
Time Frame
Month 3
Title
quality of sleep
Description
actigraphy measurements and sleep diary records
Time Frame
Month 3
Title
cortical activation level
Description
transcranial magnetic stimulation
Time Frame
Month 3
Title
cortico-spinal excitability
Description
transcranial magnetic stimulation
Time Frame
Month 3
Title
neuromuscular fatigue of peripheral function
Description
electrical nerve stimulation
Time Frame
Month 3
Title
Analysis overall quality of life : Fatigue questionnaire
Description
Fatigue questionnaire by Modified Fatigue Impact Scale (MFIS) results
Time Frame
Month 3
Title
Analysis overall quality of life :Quality of Life
Description
Quality of Life Questionnaire by SEP-59 results
Time Frame
Month 3
Title
Analysis overall quality of life :Depression
Description
Depression Questionnaire by Center for Epidemiologic Studies Depression (CES-D) results
Time Frame
Month 3
Title
Analysis overall quality of life : Sleep Quality
Description
Sleep Quality Questionnaire by Pittsburgh Sleep Quality Index (PSQ-I) results
Time Frame
Month 3
Title
Analysis overall quality of life : Physical Activity
Description
Physical Activity Questionnaire by Godin Leisure-Time Exercise Questionnaire (GLTEQ) results
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 to 70 years old Male or female With relapsing-remitting multiple sclerosis (RRMS) as defined by McDonald's 2010 criteria. Between 2 and 25 years from the onset of multiple sclerosis With a high level of fatigue, corresponding to a score of Fatigue Severity Scale> 4 and Fatigue questionnaire > 38. Expanded Disability Status Scale Score 5 Testing ≥ 4 in all leg muscles. Ability to walk for 10 minutes without stopping (self-reported) Affiliates or beneficiaries of a social security scheme Having freely given their written consent after having been informed of the purpose, course of action and potential risks involved Exclusion Criteria: Severe cerebellar spasticity or ataxia in either leg. Abnormal range of motion of the toes and/or ankle. Musculoskeletal injury that interferes with pedaling. High resting heart rate (>90 beats per minute). Blood pressure > 144/94 mmHg. Onset of a multiple sclerosis attack within 90 days prior to the study. Recent adjustment of any medication or drugs that may impact on fatigue, or taking stimulants for fatigue (e.g. Modafinil). Taking of neuro-active substances that may impair cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) throughout the study period. Contraindication to the application of a magnetic field History of co-morbid disease or conditions that would compromise the subject's safety during the study. Participation at the same time in another medical intervention study or having participated in such a study within 30 days prior to this study. Pregnant and Nursing Women Women of childbearing age without effective contraception Patient unable to understand the purpose and conditions of the study, incapable of giving consent Patient deprived of liberty or patient under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Philippe CAMDESSANCHE, MD PhD
Phone
(0)477820559
Ext
+33
Email
j.philippe.camdessanche@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine BAUDOT, CRA
Phone
(0)477829450
Ext
+33
Email
amandine.baudot@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Philippe CAMDESSANCHE, MD PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe CAMDESSANCHE, MD PhD
First Name & Middle Initial & Last Name & Degree
Florence ROBERT-VARVAT, MD
First Name & Middle Initial & Last Name & Degree
Arnaud LACOUR, MD
First Name & Middle Initial & Last Name & Degree
Laure MAZZOLA, MD
First Name & Middle Initial & Last Name & Degree
Mélanie FORESTIER, 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
David HUPIN, MD PhD
First Name & Middle Initial & Last Name & Degree
Marion RAVELOJOANA, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Individualized Versus Traditional Exercise in Combating Fatigue

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