Role of Individualized Versus Traditional Exercise in Combating Fatigue

Multiple Sclerosis Clinical Trial

— REEN-SEP  

Official title:

Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04796272
• Other study ID #: 20CH032
• Secondary ID: 2020-A00841-38
• Status: Terminated
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 30, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Adapted and individualized physical training program
Physical training program adapted and individualized according to each patient in this group
• traditional training program
Same training program for all patients in this group

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 3
Secondary	cardiorespiratory fitness	evaluated by measuring the maximum oxygen consumption (VO2max) during an incremental exercise on a cycloergometer.	Month 3
Secondary	Hematological parameters	red blood cell and hemoglobin levels measured by spectrophotometry.	Month 3
Secondary	Inflammatory parameters	c-reactive protein	Month 3
Secondary	quality of sleep	actigraphy measurements and sleep diary records	Month 3
Secondary	cortical activation level	transcranial magnetic stimulation	Month 3
Secondary	cortico-spinal excitability	transcranial magnetic stimulation	Month 3
Secondary	neuromuscular fatigue of peripheral function	electrical nerve stimulation	Month 3
Secondary	Analysis overall quality of life : Fatigue questionnaire	Fatigue questionnaire by Modified Fatigue Impact Scale (MFIS) results	Month 3
Secondary	Analysis overall quality of life :Quality of Life	Quality of Life Questionnaire by SEP-59 results	Month 3
Secondary	Analysis overall quality of life :Depression	Depression Questionnaire by Center for Epidemiologic Studies Depression (CES-D) results	Month 3
Secondary	Analysis overall quality of life : Sleep Quality	Sleep Quality Questionnaire by Pittsburgh Sleep Quality Index (PSQ-I) results	Month 3
Secondary	Analysis overall quality of life : Physical Activity	Physical Activity Questionnaire by Godin Leisure-Time Exercise Questionnaire (GLTEQ) results	Month 3