Clinical trial NCT01845896: Influence of High Intensity Exercise on Insulin Resistance, Muscle Contractile Properties, Aerobic Capacity and Body Composition in Multiple Sclerosis
Official title: Rehabilitation in MS: Influence of High Intensity Exercise on Insulin Resistance, Muscle Contractile Properties, Aerobic Capacity and Body Composition in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Healthy Controls
Keywords: high intensity interval training
combined training
insulin resistance
muscle contractile properties
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

It is assumed that the the above mentioned clinical parameters will improve due to physical exercise.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: insulin sensitivity (insulin profile)
timeFrame: change from baseline to 12 weeks
measure: muscle contractile properties
timeFrame: from baseline to 12 weeks
Secondary outcomes:
measure: muscle strength of knee extensor/flexor
timeFrame: change from baseline to 12 weeks
measure: aerobic capacity
timeFrame: change from baseline to 12 weeks
measure: cytokine profile
timeFrame: change from baseline to 12 weeks
measure: Self-reported measures
timeFrame: Change from baseline to 12 weeks
measure: body composition
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Reval
Study officials:
affiliation: Reval/Biomed, Hasselt University
name: Inez Wens, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Reval/Biomed, Hasselt University
name: Bert Opt Eijnde, Ph.D
role: STUDY_CHAIR
References:
citation: 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.
citation: Hansen 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.
citation: Wens 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.