Multiple SclerosisNCT03856801
Acute Effects of Whole-body Vibration Training in Hypoxia and Normoxia in Multiple Sclerosis Patients
A study testing Exercise in people with Multiple Sclerosis, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2018to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild or moderate disability with clinical mild spastic-ataxic gait disorder.
- stable phase of the disease.
Who cannot join
- Expanded Disability Status Scale (EDSS) < 6.
- relapsing disease within the preceding 12 months.
- corticosteroid treatment within the last months before study inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Exercise
- Keywords
- neuromuscular disease, whole-body vibration, hypoxia, strength
- Medical subject headings
- Multiple Sclerosis, Neuromuscular Diseases, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Whole-body vibration training in hypoxia and normoxia condition
| Study group | Role | What they receive |
|---|---|---|
| Whole-body vibration in normoxia condition | Experimental | Training session in normoxia condition Receives: Other: Exercise |
| Whole-body vibration in hypoxia condition | Experimental | Training session in hypoxia condition Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Voluntary Isometric Contraction of Knee Extension
Measured: Immediately before the training sessions
Maximal Voluntary Isometric Contraction of Knee Extension
Measured: Immediately after the training sessions
Rate of Force Development
Measured: Immediately before the training sessions
Rate of Force Development
Measured: Immediately after the training sessions
Central Activation Ratio
Measured: Immediately before the training sessions
Central Activation Ratio
Measured: Immediately after the training sessions
Biomechanical study of the walk by video recording
Kinematic analysis of knee and ankle angles during walking
Measured: Immediately before the training sessions
Biomechanical study of the walk by video recording
Kinematic analysis of knee and ankle angles during walking
Measured: Immediately after the training sessions
Biomechanical study of the walk by video recording
Stride amplitude during walking
Measured: Immediately before the training sessions
Biomechanical study of the walk by video recording
Stride amplitude during walking
Measured: Immediately after the training sessions
Spasticity
Pendulum test
Measured: Immediately before the training sessions
Spasticity
Pendulum test
Measured: Immediately after the training sessions
Secondary outcomes (8)
Rate of Perceived Exertion
RPE Scale 6-20
Measured: Immediately before the training sessions
Rate of Perceived Exertion
RPE Scale 6-20
Measured: Immediately after the training sessions
Walking speed
Test 10 m-walks
Measured: Immediately before the training sessions
Walking speed
Test 10 m-walks
Measured: Immediately after the training sessions
Static balance
Romberg Test with eyes open and closed. Analysis with force plates
Measured: Immediately before the training sessions
Static balance
Romberg Test with eyes open and closed. Analysis with force plates
Measured: Immediately after the training sessions
Muscle oxygenation in soleus
MOXY's
Measured: Immediately before the training sessions
Muscle oxygenation in soleus
MOXY's
Measured: Immediately after the training sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start15 Jun 2018
- Primary completion30 Jul 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacobo Á. Rubio, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856801
- Sponsor's protocol ID
- CE061908
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Whole-body Vibration Training in Hypoxia and Normoxia Condition on Neuromuscular Performance and Mobility in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03856801
- Acronym / sponsor ID
- CE061908
- Conditions
- Multiple Sclerosis
- Keywords
- neuromuscular disease, whole-body vibration, hypoxia, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-body vibration in normoxia condition | Experimental | Other: ExerciseTraining session in normoxia condition |
| Whole-body vibration in hypoxia condition | Experimental | Other: ExerciseTraining session in hypoxia condition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mild or moderate disability with clinical mild spastic-ataxic gait disorder.
- stable phase of the disease.
Key exclusion criteria (3 listed)
- Expanded Disability Status Scale (EDSS) < 6.
- relapsing disease within the preceding 12 months.
- corticosteroid treatment within the last months before study inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseWhole-body vibration training in hypoxia and normoxia condition | Other | Whole-body vibration in hypoxia condition, Whole-body vibration in normoxia condition |
Primary outcome
Maximal Voluntary Isometric Contraction of Knee Extension
Time frame: Immediately before the training sessions
Maximal Voluntary Isometric Contraction of Knee Extension
Time frame: Immediately after the training sessions
Rate of Force Development
Time frame: Immediately before the training sessions
Rate of Force Development
Time frame: Immediately after the training sessions
Central Activation Ratio
Time frame: Immediately before the training sessions
Central Activation Ratio
Time frame: 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
Biomechanical study of the walk by video recording
Time frame: Immediately after the training sessions
Kinematic analysis of knee and ankle angles during walking
Biomechanical study of the walk by video recording
Time frame: Immediately before the training sessions
Stride amplitude during walking
Biomechanical study of the walk by video recording
Time frame: Immediately after the training sessions
Stride amplitude during walking
Spasticity
Time frame: Immediately before the training sessions
Pendulum test
Spasticity
Time frame: Immediately after the training sessions
Pendulum test
8 secondary outcomes
Rate of Perceived Exertion
Time frame: Immediately before the training sessions
Rate of Perceived Exertion
Time frame: Immediately after the training sessions
Walking speed
Time frame: Immediately before the training sessions
Walking speed
Time frame: Immediately after the training sessions
Static balance
Time frame: Immediately before the training sessions
Static balance
Time frame: Immediately after the training sessions
Muscle oxygenation in soleus
Time frame: Immediately before the training sessions
Muscle oxygenation in soleus
Time frame: Immediately after the training sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Multiple Sclerosis, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Voluntary Isometric Contraction of Knee Extension (time frame: Immediately before the training sessions). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.