NCT06505421

Brief Summary

The goal of this observational study is to compare the impact of eccentric resistance training to traditional resistance training on fatigue in persons with multiple sclerosis (MS). The primary question this study is asking is the following: is eccentric resistance training more fatiguing than traditional resistance training in persons with MS?. Participants will be asked to come for two sessions for two weeks. In the first week, subjects will undergo a bout of either traditional or eccentric resistance training. The next day they will return to assess their level of fatigue. The following week the subject will return and undergo whatever type of training they did not experience the first week, and it's effects on fatigue will again be assessed. The difference between the subjects level of fatigue for either condition will be compared.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jul 2024Dec 2026

Study Start

First participant enrolled

July 1, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

July 3, 2024

Last Update Submit

July 16, 2024

Conditions

Keywords

Exerciseresistance training

Outcome Measures

Primary Outcomes (1)

  • 6-Minute walk test

    Subject walks at best possible pace with or without assistive device for 6 minutes. Total distance walked as well as distance per minute is measured

    Pre-intervention and post intervention for each condition (eccentric and traditional strength training). There is a 36-48 hour period between the pre-intervention and post intervention for each condition

Secondary Outcomes (1)

  • Visual analog scale of fatigue

    Pre-intervention and post-intervention for each condition (eccentric vs traditional strength training). There is a 36-48 hour period between the pre-intervention and post intervention for each condition

Study Arms (1)

Persons with Multiple sclerosis

Eccentric resistance training , traditional resistance training

Behavioral: Resistance training

Interventions

Eccentric resistance training and tradional resistance training

Persons with Multiple sclerosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory persons with MS

You may qualify if:

  • Definitive diagnosis of Multiple Sclerosis.
  • Ability to walk for 6 minutes continuously with or without assistive device
  • Ability read, understand and sign and informed consent

You may not qualify if:

  • Evidence of recent exacerbation in the last 2 months prior to starting the study
  • Orthopedic, cardiopulmonary, or non -MS neurologic condition that could interfere with carrying out the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter College, Physical Therapy Department, City University of New York

New York, New York, 10010, United States

RECRUITING

Related Publications (3)

  • Patrocinio de Oliveira CE, Moreira OC, Carrion-Yagual ZM, Medina-Perez C, de Paz JA. Effects of Classic Progressive Resistance Training Versus Eccentric-Enhanced Resistance Training in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 May;99(5):819-825. doi: 10.1016/j.apmr.2017.10.021. Epub 2017 Nov 27.

    PMID: 29191417BACKGROUND
  • Wochatz M, Schraplau A, Engel T, Zecher MM, Sharon H, Alt Y, Mayer F, Kalron A. Application of eccentric training in various clinical populations: Protocol for a multi-centered pilot and feasibility study in people with low back pain and people with multiple sclerosis. PLoS One. 2022 Dec 22;17(12):e0270875. doi: 10.1371/journal.pone.0270875. eCollection 2022.

    PMID: 36548298BACKGROUND
  • Gauche E, Couturier A, Lepers R, Michaut A, Rabita G, Hausswirth C. Neuromuscular fatigue following high versus low-intensity eccentric exercise of biceps brachii muscle. J Electromyogr Kinesiol. 2009 Dec;19(6):e481-6. doi: 10.1016/j.jelekin.2009.01.006. Epub 2009 Feb 12.

    PMID: 19217311BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisFatigueMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Herbert Karpatkin, DSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 17, 2024

Study Start

July 1, 2024

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations