NCT03856801

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. Moderate intensity strength training has been shown to improve strength and mobility in persons with MS. It was suggested that whole-body vibration training (WBVT) is effective to improve muscle strength, such as resistance training, resulting from both neural and structural adaptations. On the other hand, traditional strength training in hypoxia has garnered much attention. This method has shown improvements in isometric strength and increases in muscle size.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jun 2018

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

Study Start

First participant enrolled

June 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

February 13, 2019

Last Update Submit

February 25, 2019

Conditions

Multiple Sclerosis

Keywords

neuromuscular diseasewhole-body vibrationhypoxiastrength

Outcome Measures

Primary Outcomes (12)

  • Maximal Voluntary Isometric Contraction of Knee Extension

    Immediately before the training sessions

  • Maximal Voluntary Isometric Contraction of Knee Extension

    Immediately after the training sessions

  • Rate of Force Development

    Immediately before the training sessions

  • Rate of Force Development

    Immediately after the training sessions

  • Central Activation Ratio

    Immediately before the training sessions

  • Central Activation Ratio

    Immediately after the training sessions

  • Biomechanical study of the walk by video recording

    Kinematic analysis of knee and ankle angles during walking

    Immediately before the training sessions

  • Biomechanical study of the walk by video recording

    Kinematic analysis of knee and ankle angles during walking

    Immediately after the training sessions

  • Biomechanical study of the walk by video recording

    Stride amplitude during walking

    Immediately before the training sessions

  • Biomechanical study of the walk by video recording

    Stride amplitude during walking

    Immediately after the training sessions

  • Spasticity

    Pendulum test

    Immediately before the training sessions

  • Spasticity

    Pendulum test

    Immediately after the training sessions

Secondary Outcomes (8)

  • Rate of Perceived Exertion

    Immediately before the training sessions

  • Rate of Perceived Exertion

    Immediately after the training sessions

  • Walking speed

    Immediately before the training sessions

  • Walking speed

    Immediately after the training sessions

  • Static balance

    Immediately before the training sessions

  • +3 more secondary outcomes

Study Arms (2)

Whole-body vibration in normoxia condition

EXPERIMENTAL

Training session in normoxia condition

Other: Exercise

Whole-body vibration in hypoxia condition

EXPERIMENTAL

Training session in hypoxia condition

Other: Exercise

Interventions

ExerciseOTHER

Whole-body vibration training in hypoxia and normoxia condition

Whole-body vibration in hypoxia conditionWhole-body vibration in normoxia condition

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 SclerosisNeuromuscular DiseasesHypoxia

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor Titular

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 27, 2019

Study Start

June 15, 2018

Primary Completion

July 30, 2018

Study Completion

August 30, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

ES(1)