Multiple SclerosisNCT01845896
Influence of High Intensity Exercise on Insulin Resistance, Muscle Contractile Properties, Aerobic Capacity and Body Composition in Multiple Sclerosis
A study testing Training in people with Multiple Sclerosis and Healthy Controls, run by Bert Op't Eijnde at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate the effects of a combined training programme and a high intensity interval training programme on insulin resistance, muscle strength/ muscle contractile properties, aerobic capacity and body composition in MS patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Healthy Controls
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2013to Mar 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed MS according to the McDonald criteria
- Expanded Disability Status Scale (EDSS) between 0.5 and 6
- Be able to train 5 times in 2 weeks at the University
Who cannot join
- Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases (like diabetes type 2)
- Having had an relapse in a period of 3 months prior to the start of the intervention period
- Having an relapse during the intervention period
- Pregnancy and other contra indications for physical activity
- Mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation in MS: Influence of High Intensity Exercise on Insulin Resistance, Muscle Contractile Properties, Aerobic Capacity and Body Composition in Multiple Sclerosis
The purpose of this study is to investigate the effects of a combined training programme and a high intensity interval training programme on insulin resistance, muscle strength/ muscle contractile properties, aerobic capacity and body composition in MS patients.
It is assumed that the the above mentioned clinical parameters will improve due to physical exercise.
- Conditions
- Multiple Sclerosis, Healthy Controls
- Being tested
- Training
- Keywords
- high intensity interval training, combined training, insulin resistance, muscle contractile properties
- Medical subject headings
- Multiple Sclerosis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Also called 12 weeks of high intensity interval training or combined exercise
| Study group | Role | What they receive |
|---|---|---|
| Combined exercise | Experimental | 12 weeks combined exercise programme (supervised) Receives: Behavioral: Training |
| High intensity interval training | Experimental | 12 weeks high intensity interval exercise programme (supervised) Receives: Behavioral: Training |
| Control | No intervention | sedentary/habitual lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity (insulin profile)
glucose and insulin concentration measurements in blood
Measured: change from baseline to 12 weeks
muscle contractile properties
measurements of cross sectional area and fiber distribution in muscle fibers of the m. vastus lateralis + measurements of enzymatic reactions, ATP, glycogen, ...
Measured: from baseline to 12 weeks
Secondary outcomes (5)
muscle strength of knee extensor/flexor
by means of an isokinetic dynamometer the muscle strength and endurance will be measured
Measured: change from baseline to 12 weeks
aerobic capacity
by means of a submaximal endurance test (ergometer)
Measured: change from baseline to 12 weeks
cytokine profile
measurements of blood cytokine levels
Measured: change from baseline to 12 weeks
Self-reported measures
The self-reported measures contains some questionnaires
Measured: Change from baseline to 12 weeks
body composition
Weight, body fat% and lean tissue% will be assessed by means of a DEXA scan
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bert Op't Eijnde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bert Op't Eijnde, Hasselt University
- Investigators
- Inez Wens, M.Sc., Principal investigator, Reval/Biomed, Hasselt UniversityBert Opt Eijnde, Ph.D, Study chair, Reval/Biomed, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845896
- Sponsor's protocol ID
- 13.20/reva13.02
- Status last verified
- May 2014
- First submitted
- 30 Apr 2013
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wens I, Dalgas U, Vandenabeele F, Grevendonk L, Verboven K, Hansen D, Eijnde BO. High Intensity Exercise in Multiple Sclerosis: Effects on Muscle Contractile Characteristics and Exercise Capacity, a Randomised Controlled Trial. PLoS One. 2015 Sep 29;10(9):e0133697. doi: 10.1371/journal.pone.0133697. eCollection 2015.
PubMed 26418222Hansen D, Wens I, Vandenabeele F, Verboven K, Eijnde BO. Altered signaling for mitochondrial and myofibrillar biogenesis in skeletal muscles of patients with multiple sclerosis. Transl Res. 2015 Jul;166(1):70-9. doi: 10.1016/j.trsl.2015.01.006. Epub 2015 Jan 20.
PubMed 25666356Wens I, Dalgas U, Vandenabeele F, Krekels M, Grevendonk L, Eijnde BO. Multiple sclerosis affects skeletal muscle characteristics. PLoS One. 2014 Sep 29;9(9):e108158. doi: 10.1371/journal.pone.0108158. eCollection 2014.
PubMed 25264868
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation in MS: Influence of High Intensity Exercise on Insulin Resistance, Muscle Contractile Properties, Aerobic Capacity and Body Composition in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01845896
- Acronym / sponsor ID
- 13.20/reva13.02
- Conditions
- Multiple Sclerosis, Healthy Controls
- Keywords
- high intensity interval training, combined training, insulin resistance, muscle contractile properties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bert Op't EijndeUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 May 2013 (estimated)
- 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.
The purpose of this study is to investigate the effects of a combined training programme and a high intensity interval training programme on insulin resistance, muscle strength/ muscle contractile properties, aerobic capacity and body composition in MS patients.
It is assumed that the the above mentioned clinical parameters will improve due to physical exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined exercise | Experimental | Behavioral: Training12 weeks combined exercise programme (supervised) |
| High intensity interval training | Experimental | Behavioral: Training12 weeks high intensity interval exercise programme (supervised) |
| Control | No intervention | –sedentary/habitual lifestyle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed MS according to the McDonald criteria
- Expanded Disability Status Scale (EDSS) between 0.5 and 6
- Be able to train 5 times in 2 weeks at the University
Key exclusion criteria (5 listed)
- Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases (like diabetes type 2)
- Having had an relapse in a period of 3 months prior to the start of the intervention period
- Having an relapse during the intervention period
- Pregnancy and other contra indications for physical activity
- Mental disorders
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 |
|---|---|---|
| TrainingAlso: 12 weeks of high intensity interval training or combined exercise | Behavioural | Combined exercise, High intensity interval training |
Primary outcome
insulin sensitivity (insulin profile)
Time frame: change from baseline to 12 weeks
glucose and insulin concentration measurements in blood
muscle contractile properties
Time frame: from baseline to 12 weeks
measurements of cross sectional area and fiber distribution in muscle fibers of the m. vastus lateralis + measurements of enzymatic reactions, ATP, glycogen, ...
5 secondary outcomes
muscle strength of knee extensor/flexor
Time frame: change from baseline to 12 weeks
aerobic capacity
Time frame: change from baseline to 12 weeks
cytokine profile
Time frame: change from baseline to 12 weeks
Self-reported measures
Time frame: Change from baseline to 12 weeks
body composition
Time frame: Change from baseline to 12 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 6 May 2014.
- Derived from this study: PubMed 26418222Wens I, Dalgas U, Vandenabeele F, Grevendonk L, Verboven K, Hansen D, Eijnde BO. High Intensity Exercise in Multiple Sclerosis: Effects on Muscle Contractile Characteristics and Exercise Capacity, a Randomised Controlled Trial. PLoS One. 2015 Sep 29;10(9):e0133697. doi: 10.1371/journal.pone.0133697. eCollection 2015.
- Derived from this study: PubMed 25666356Hansen D, Wens I, Vandenabeele F, Verboven K, Eijnde BO. Altered signaling for mitochondrial and myofibrillar biogenesis in skeletal muscles of patients with multiple sclerosis. Transl Res. 2015 Jul;166(1):70-9. doi: 10.1016/j.trsl.2015.01.006. Epub 2015 Jan 20.
- Derived from this study: PubMed 25264868Wens I, Dalgas U, Vandenabeele F, Krekels M, Grevendonk L, Eijnde BO. Multiple sclerosis affects skeletal muscle characteristics. PLoS One. 2014 Sep 29;9(9):e108158. doi: 10.1371/journal.pone.0108158. eCollection 2014.
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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.
Inez Wens, M.Sc. principal investigator
Reval/Biomed, Hasselt University
Bert Opt Eijnde, Ph.D study chair
Reval/Biomed, Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Multiple Sclerosis and Healthy Controls, run by Bert Op't Eijnde at 1 site in Belgium.
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 3 inclusion and 5 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 6 May 2014. 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 Belgium. 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?
insulin sensitivity (insulin profile) (time frame: change from baseline to 12 weeks). The study lists 2 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 NCT01845896, which also lists 3 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 6 May 2014.