Multiple SclerosisNCT01718392
Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity
A study testing Training in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
Trial summary
the purpose of this study is to investigate the development of insulin resistance in multiple sclerosis patients + explaining the effects of a combined training programme on insulin resistance, muscle power and aerobic capacity in multiple sclerosis 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
- 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
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2011to Sep 2013
- 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
the purpose of this study is to investigate the development of insulin resistance in multiple sclerosis patients + explaining the effects of a combined training programme on insulin resistance, muscle power and aerobic capacity in multiple sclerosis patients
- Conditions
- Multiple Sclerosis
- Being tested
- Training
- Keywords
- combined training, insulin resistance
- 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 24 weeks combined exercise programma (supervised)
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | 24 weeks combined 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 24 weeks
Secondary outcomes (10)
aerobic capacity
by means of a submaximal endurance test (ergometer)
Measured: change from baseline to 24 weeks
aerobic capacity - lactate concentrations
by means of a submaximal endurance test (ergometer) to determine lactate concentrations (mmol/L)
Measured: change from baseline to 24 weeks
cytokine profile
measurements of blood cytokine levels
Measured: change from baseline to 24 weeks
walking performance
Walking performance will be assessed by means of 2 and 6 minute walk test, 25-foot walk test, Chair rise test, Stair climb test
Measured: change from baseline to 24 weeks
Self-reported measures
The self-reported measures contains some questionnaires
Measured: Change from baseline to 24 weeks
body composition
Weight, body fat% and lean tissue% will be assessed by means of a DEXA (Dual-energy X-ray absorptiometry) scan
Measured: Change from baseline to 24 weeks
muscle strength of knee flexor
by means of an isokinetic dynamometer the muscle strength and endurance will be measured
Measured: change from baseline to 24 weeks
muscle strength of knee extensor
by means of an isokinetic dynamometer the muscle strength and endurance will be measured
Measured: change from baseline to 24 weeks
muscle strength of elbow flexor
by means of an isokinetic dynamometer the muscle strength will be measured
Measured: change from baseline to 24 weeks
muscle strength of elbow extensor
by means of an isokinetic dynamometer the muscle strength will be measured
Measured: change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionSep 2013
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bert Op't Eijnde, Hasselt University
- Investigators
- Inez Wens, M.Sc., Principal investigator, Reval/Biomed, Hasselt UniversityBert Op't Eijnde, Ph.D., Study chair, Reval/Biomed, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718392
- Sponsor's protocol ID
- CME 2011/311
- Status last verified
- Nov 2016
- First submitted
- 23 Oct 2012
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity
- ClinicalTrials.gov ID
- NCT01718392
- Acronym / sponsor ID
- CME 2011/311
- Conditions
- Multiple Sclerosis
- Keywords
- combined training, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 31 Oct 2012 (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 development of insulin resistance in multiple sclerosis patients + explaining the effects of a combined training programme on insulin resistance, muscle power and aerobic capacity in multiple sclerosis patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Training24 weeks combined 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: 24 weeks combined exercise programma (supervised) | Behavioural | Training |
Primary outcome
insulin sensitivity (insulin profile)
Time frame: change from baseline to 24 weeks
glucose and insulin concentration measurements in blood
10 secondary outcomes
aerobic capacity
Time frame: change from baseline to 24 weeks
aerobic capacity - lactate concentrations
Time frame: change from baseline to 24 weeks
cytokine profile
Time frame: change from baseline to 24 weeks
walking performance
Time frame: change from baseline to 24 weeks
Self-reported measures
Time frame: Change from baseline to 24 weeks
body composition
Time frame: Change from baseline to 24 weeks
muscle strength of knee flexor
Time frame: change from baseline to 24 weeks
muscle strength of knee extensor
Time frame: change from baseline to 24 weeks
muscle strength of elbow flexor
Time frame: change from baseline to 24 weeks
muscle strength of elbow extensor
Time frame: change from baseline to 24 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 25 Nov 2016.
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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 Op't 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, run by Hasselt University 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 25 Nov 2016. 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 24 weeks). 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 25 Nov 2016.