Acute Effects of Whole-body Vibration Training in Hypoxia and Normoxia in Multiple Sclerosis Patients

February 25, 2019 updated by: Jacobo Á. Rubio, Universidad Católica San Antonio de Murcia

Acute Effects of Whole-body Vibration Training in Hypoxia and Normoxia Condition on Neuromuscular Performance and Mobility in Patients With Multiple Sclerosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Crossover.
  • 13 patients with multiple sclerosis were recruited.
  • Patients performed two sessions: whole-body vibration training in normoxia condition and whole-body vibration in hypoxia condition.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Murcia, Spain, 30107
        • Universidad Católica San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Expanded Disability Status Scale (EDSS) < 6.
  • relapsing disease within the preceding 12 months.
  • corticosteroid treatment within the last months before study inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole-body vibration in normoxia condition
Training session in normoxia condition
Whole-body vibration training in hypoxia and normoxia condition
Experimental: Whole-body vibration in hypoxia condition
Training session in hypoxia condition
Whole-body vibration training in hypoxia and normoxia condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Voluntary Isometric Contraction of Knee Extension
Time Frame: Immediately before the training sessions
Immediately before the training sessions
Maximal Voluntary Isometric Contraction of Knee Extension
Time Frame: Immediately after the training sessions
Immediately after the training sessions
Rate of Force Development
Time Frame: Immediately before the training sessions
Immediately before the training sessions
Rate of Force Development
Time Frame: Immediately after the training sessions
Immediately after the training sessions
Central Activation Ratio
Time Frame: Immediately before the training sessions
Immediately before the training sessions
Central Activation Ratio
Time Frame: Immediately after the training sessions
Immediately after the training sessions
Biomechanical study of the walk by video recording
Time Frame: Immediately before the training sessions
Kinematic analysis of knee and ankle angles during walking
Immediately before the training sessions
Biomechanical study of the walk by video recording
Time Frame: Immediately after the training sessions
Kinematic analysis of knee and ankle angles during walking
Immediately after the training sessions
Biomechanical study of the walk by video recording
Time Frame: Immediately before the training sessions
Stride amplitude during walking
Immediately before the training sessions
Biomechanical study of the walk by video recording
Time Frame: Immediately after the training sessions
Stride amplitude during walking
Immediately after the training sessions
Spasticity
Time Frame: Immediately before the training sessions
Pendulum test
Immediately before the training sessions
Spasticity
Time Frame: Immediately after the training sessions
Pendulum test
Immediately after the training sessions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Perceived Exertion
Time Frame: Immediately before the training sessions
RPE Scale 6-20
Immediately before the training sessions
Rate of Perceived Exertion
Time Frame: Immediately after the training sessions
RPE Scale 6-20
Immediately after the training sessions
Walking speed
Time Frame: Immediately before the training sessions
Test 10 m-walks
Immediately before the training sessions
Walking speed
Time Frame: Immediately after the training sessions
Test 10 m-walks
Immediately after the training sessions
Static balance
Time Frame: Immediately before the training sessions
Romberg Test with eyes open and closed. Analysis with force plates
Immediately before the training sessions
Static balance
Time Frame: Immediately after the training sessions
Romberg Test with eyes open and closed. Analysis with force plates
Immediately after the training sessions
Muscle oxygenation in soleus
Time Frame: Immediately before the training sessions
MOXY's
Immediately before the training sessions
Muscle oxygenation in soleus
Time Frame: Immediately after the training sessions
MOXY's
Immediately after the training sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

July 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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