Role of Individualized Versus Traditional Exercise in Combating Fatigue

NCT04796272 | Terminated

• 2 other identifiers: 20CH0322020-A00841-38
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; individual exercise; fatigue; traditional exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• cardiorespiratory fitness

  Month 3

• Hematological parameters

  Month 3

• Inflammatory parameters

  Month 3

• quality of sleep

  Month 3

• cortical activation level

  Month 3

Study Arms (2)

Traditional exercise

ACTIVE COMPARATOR

fatigued multiple sclerosis patients with a traditional training program

Other: traditional training program

Individual exercise

EXPERIMENTAL

tired multiple sclerosis patients with an adapted and individualized training program

Other: Adapted and individualized physical training program

Interventions

Adapted and individualized physical training program OTHER

Physical training program adapted and individualized according to each patient in this group

Individual exercise

traditional training program OTHER

Same training program for all patients in this group

Traditional exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Study Officials

• Jean Philippe CAMDESSANCHE, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: March 12, 2021
• Study Start: April 2, 2021
• Primary Completion: February 23, 2022
• Study Completion: June 30, 2022
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)