Multiple SclerosisNCT04452760
Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
A study testing Physical exercise and Testing sessions 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 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Physical exercise and Testing sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2020to 5 Oct 2020
- 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 20 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
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. Strength training has been shown to improve strength and mobility in persons with MS.
Read the detailed description
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. Resistance training has been shown to improve strength, sleep quality and mobility in persons with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Physical exercise, Testing sessions
- Keywords
- neurological disorders, resistance training, strength training, sleep quality, neuromuscular performance, functional capacity
- Medical subject headings
- Multiple Sclerosis, Nervous System Diseases, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
Physical exercise intervention
Testing sessionsOther
Testing sessions
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Only testing sessions Receives: Other: Testing sessions |
| Progressive resistance training group | Experimental | 10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises. Receives: Other: Physical exercise; Other: Testing sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Voluntary Isometric Contraction of Knee Extension
the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
Measured: Before the program training
Maximal Voluntary Isometric Contraction of Knee Extension
the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
Measured: After 10 weeks
Rate of Force Development
Rate of force development in knee extension
Measured: Before the program training
Rate of Force Development
Rate of force development in knee extension
Measured: After 10 weeks
Central Activation Ratio
The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
Measured: Before the program training
Central Activation Ratio
The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
Measured: After 10 weeks
Spasticity
Pendulum test
Measured: Before the program training
Spasticity
Pendulum test
Measured: After 10 weeks
Secondary outcomes (10)
Walking speed
Test 10 m-walks
Measured: Before the program training
Walking speed
Test 10 m-walks
Measured: After 10 weeks
Static Balance
Romberg Test with eyes open and closed. Analysis with force plates
Measured: Before the program training
Static Balance
Romberg Test with eyes open and closed. Analysis with force plates
Measured: After 10 weeks
Functional capacity
Sit-to-Stand Test
Measured: Before the program training
Functional capacity
Sit-to-Stand Test
Measured: After 10 weeks
Heart Rate Variability
Sleeping Heart Rate Variability
Measured: Before the program training
Heart Rate Variability
Sleeping Heart Rate Variability
Measured: After 10 weeks
Sleep Quality
Acelerometry and Karolinska Sleep Diary
Measured: Before the program training
Sleep Quality
Acelerometry and Karolinska Sleep Diary
Measured: After 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start15 Jul 2020
- Primary completion1 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- Investigators
- Jacobo Á Rubio-Arias, Dr, Principal investigator, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452760
- Sponsor's protocol ID
- UCAM-CE071923
- Status last verified
- Oct 2020
- First submitted
- 24 Jun 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be published in a journal
Publications
Andreu-Caravaca L, Ramos-Campo DJ, Chung LH, Rubio-Arias JA. Can strength training modify voluntary activation, contractile properties and spasticity in Multiple Sclerosis?: A randomized controlled trial. Physiol Behav. 2022 Oct 15;255:113932. doi: 10.1016/j.physbeh.2022.113932. Epub 2022 Jul 27.
PubMed 35905806Andreu-Caravaca L, Ramos-Campo DJ, Abellan-Aynes O, Avila-Gandia V, Chung LH, Manonelles P, Rubio-Arias JA. 10-Weeks of resistance training improves sleep quality and cardiac autonomic control in persons with multiple sclerosis. Disabil Rehabil. 2022 Sep;44(18):5241-5249. doi: 10.1080/09638288.2021.1934738. Epub 2021 Jun 9.
PubMed 34107841
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04452760
- Acronym / sponsor ID
- UCAM-CE071923
- Conditions
- Multiple Sclerosis
- Keywords
- neurological disorders, resistance training, strength training, sleep quality, neuromuscular performance, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 30 Jun 2020 (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. Strength training has been shown to improve strength and mobility in persons with MS.
Detailed description
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. Resistance training has been shown to improve strength, sleep quality and mobility in persons with MS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Testing sessionsOnly testing sessions |
| Progressive resistance training group | Experimental | Other: Physical exercise, Other: Testing sessions10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises. |
Who may qualify
- Ages
- 20 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 |
|---|---|---|
| Physical exercisePhysical exercise intervention | Other | Progressive resistance training group |
| Testing sessionsTesting sessions | Other | Control group, Progressive resistance training group |
Primary outcome
Maximal Voluntary Isometric Contraction of Knee Extension
Time frame: Before the program training
the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
Maximal Voluntary Isometric Contraction of Knee Extension
Time frame: After 10 weeks
the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
Rate of Force Development
Time frame: Before the program training
Rate of force development in knee extension
Rate of Force Development
Time frame: After 10 weeks
Rate of force development in knee extension
Central Activation Ratio
Time frame: Before the program training
The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
Central Activation Ratio
Time frame: After 10 weeks
The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
Spasticity
Time frame: Before the program training
Pendulum test
Spasticity
Time frame: After 10 weeks
Pendulum test
10 secondary outcomes
Walking speed
Time frame: Before the program training
Walking speed
Time frame: After 10 weeks
Static Balance
Time frame: Before the program training
Static Balance
Time frame: After 10 weeks
Functional capacity
Time frame: Before the program training
Functional capacity
Time frame: After 10 weeks
Heart Rate Variability
Time frame: Before the program training
Heart Rate Variability
Time frame: After 10 weeks
Sleep Quality
Time frame: Before the program training
Sleep Quality
Time frame: After 10 weeks
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 8 Oct 2020.
- Derived from this study: PubMed 35905806Andreu-Caravaca L, Ramos-Campo DJ, Chung LH, Rubio-Arias JA. Can strength training modify voluntary activation, contractile properties and spasticity in Multiple Sclerosis?: A randomized controlled trial. Physiol Behav. 2022 Oct 15;255:113932. doi: 10.1016/j.physbeh.2022.113932. Epub 2022 Jul 27.
- Derived from this study: PubMed 34107841Andreu-Caravaca L, Ramos-Campo DJ, Abellan-Aynes O, Avila-Gandia V, Chung LH, Manonelles P, Rubio-Arias JA. 10-Weeks of resistance training improves sleep quality and cardiac autonomic control in persons with multiple sclerosis. Disabil Rehabil. 2022 Sep;44(18):5241-5249. doi: 10.1080/09638288.2021.1934738. Epub 2021 Jun 9.
- Individual participant dataSharing planned: Yes. The data will be published in a journal
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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.
Jacobo Á Rubio-Arias, Dr principal investigator
Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and Testing sessions 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 8 Oct 2020. 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: Before the program training). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04452760, which also lists 2 linked publications.
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 8 Oct 2020.