- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03856801
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
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
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-
-
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE061908
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.