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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring neuromuscular disease, whole-body vibration, hypoxia, strength

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad Católica San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Whole-body vibration in normoxia condition

Whole-body vibration in hypoxia condition

Arm Description

Training session in normoxia condition

Training session in hypoxia condition

Outcomes

Primary Outcome Measures

Maximal Voluntary Isometric Contraction of Knee Extension
Maximal Voluntary Isometric Contraction of Knee Extension
Rate of Force Development
Rate of Force Development
Central Activation Ratio
Central Activation Ratio
Biomechanical study of the walk by video recording
Kinematic analysis of knee and ankle angles during walking
Biomechanical study of the walk by video recording
Kinematic analysis of knee and ankle angles during walking
Biomechanical study of the walk by video recording
Stride amplitude during walking
Biomechanical study of the walk by video recording
Stride amplitude during walking
Spasticity
Pendulum test
Spasticity
Pendulum test

Secondary Outcome Measures

Rate of Perceived Exertion
RPE Scale 6-20
Rate of Perceived Exertion
RPE Scale 6-20
Walking speed
Test 10 m-walks
Walking speed
Test 10 m-walks
Static balance
Romberg Test with eyes open and closed. Analysis with force plates
Static balance
Romberg Test with eyes open and closed. Analysis with force plates
Muscle oxygenation in soleus
MOXY's
Muscle oxygenation in soleus
MOXY's

Full Information

First Posted
February 13, 2019
Last Updated
February 25, 2019
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT03856801
Brief Title
Acute Effects of Whole-body Vibration Training in Hypoxia and Normoxia in Multiple Sclerosis Patients
Official Title
Acute Effects of Whole-body Vibration Training in Hypoxia and Normoxia Condition on Neuromuscular Performance and Mobility in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
neuromuscular disease, whole-body vibration, hypoxia, strength

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole-body vibration in normoxia condition
Arm Type
Experimental
Arm Description
Training session in normoxia condition
Arm Title
Whole-body vibration in hypoxia condition
Arm Type
Experimental
Arm Description
Training session in hypoxia condition
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Whole-body vibration training in hypoxia and normoxia condition
Primary Outcome Measure Information:
Title
Maximal Voluntary Isometric Contraction of Knee Extension
Time Frame
Immediately before the training sessions
Title
Maximal Voluntary Isometric Contraction of Knee Extension
Time Frame
Immediately after the training sessions
Title
Rate of Force Development
Time Frame
Immediately before the training sessions
Title
Rate of Force Development
Time Frame
Immediately after the training sessions
Title
Central Activation Ratio
Time Frame
Immediately before the training sessions
Title
Central Activation Ratio
Time Frame
Immediately after the training sessions
Title
Biomechanical study of the walk by video recording
Description
Kinematic analysis of knee and ankle angles during walking
Time Frame
Immediately before the training sessions
Title
Biomechanical study of the walk by video recording
Description
Kinematic analysis of knee and ankle angles during walking
Time Frame
Immediately after the training sessions
Title
Biomechanical study of the walk by video recording
Description
Stride amplitude during walking
Time Frame
Immediately before the training sessions
Title
Biomechanical study of the walk by video recording
Description
Stride amplitude during walking
Time Frame
Immediately after the training sessions
Title
Spasticity
Description
Pendulum test
Time Frame
Immediately before the training sessions
Title
Spasticity
Description
Pendulum test
Time Frame
Immediately after the training sessions
Secondary Outcome Measure Information:
Title
Rate of Perceived Exertion
Description
RPE Scale 6-20
Time Frame
Immediately before the training sessions
Title
Rate of Perceived Exertion
Description
RPE Scale 6-20
Time Frame
Immediately after the training sessions
Title
Walking speed
Description
Test 10 m-walks
Time Frame
Immediately before the training sessions
Title
Walking speed
Description
Test 10 m-walks
Time Frame
Immediately after the training sessions
Title
Static balance
Description
Romberg Test with eyes open and closed. Analysis with force plates
Time Frame
Immediately before the training sessions
Title
Static balance
Description
Romberg Test with eyes open and closed. Analysis with force plates
Time Frame
Immediately after the training sessions
Title
Muscle oxygenation in soleus
Description
MOXY's
Time Frame
Immediately before the training sessions
Title
Muscle oxygenation in soleus
Description
MOXY's
Time Frame
Immediately after the training sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidad Católica San Antonio
City
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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