NCT04276324

Brief Summary

Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. Strength training has been shown to improve strength and mobility in persons with MS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

February 17, 2020

Last Update Submit

October 22, 2020

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (8)

  • Maximal Voluntary Isometric Contraction of Knee Extension

    Before the program training

  • Maximal Voluntary Isometric Contraction of Knee Extension

    After 10 weeks

  • Rate of Force Development

    Before the program training

  • Rate of Force Development

    After 10 weeks

  • Central Activation Ratio

    Before the program training

  • Central Activation Ratio

    After 10 weeks

  • Spasticity

    Pendulum test

    Before the program training

  • Spasticity

    Pendulum test

    After 10 weeks

Secondary Outcomes (10)

  • Walking speed

    Before the program training

  • Walking speed

    After 10 weeks

  • Static balance

    Before the program training

  • Static balance

    After 10 weeks

  • Functional capacity

    Before the program training

  • +5 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Only testing sessions

Other: Testing sessions

Resistance training group

EXPERIMENTAL

Ten weeks of resistance training

Other: Resistance trainingOther: Testing sessions

Interventions

Resistance trainingOTHER

Ten weeks of resistance training

Resistance training group
Testing sessionsOTHER

Testing sessions

Control GroupResistance training group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • mild or moderate disability with clinical mild spastic-ataxic gait disorder.
  • stable phase of the disease.

You may not qualify if:

  • Expanded Disability Status Scale (EDSS) \< 6.
  • relapsing disease within the preceding 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica San Antonio

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jacobo Á Rubio-Arias, Dr

    Universidad Católica San Antonio de Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

March 10, 2020

Primary Completion

June 15, 2020

Study Completion

October 15, 2020

Last Updated

October 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

The data will be published in a journal

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After the completion of the study

Locations

ES(1)