NCT01845896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

April 30, 2013

Last Update Submit

May 3, 2014

Conditions

Multiple SclerosisHealthy Controls

Keywords

high intensity interval trainingcombined traininginsulin resistancemuscle contractile properties

Outcome Measures

Primary Outcomes (2)

  • insulin sensitivity (insulin profile)

    glucose and insulin concentration measurements in blood

    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, ...

    from baseline to 12 weeks

Secondary Outcomes (5)

  • muscle strength of knee extensor/flexor

    change from baseline to 12 weeks

  • aerobic capacity

    change from baseline to 12 weeks

  • cytokine profile

    change from baseline to 12 weeks

  • Self-reported measures

    Change from baseline to 12 weeks

  • body composition

    Change from baseline to 12 weeks

Study Arms (3)

Combined exercise

EXPERIMENTAL

12 weeks combined exercise programme (supervised)

Behavioral: Training

High intensity interval training

EXPERIMENTAL

12 weeks high intensity interval exercise programme (supervised)

Behavioral: Training

Control

NO INTERVENTION

sedentary/habitual lifestyle

Interventions

TrainingBEHAVIORAL
Also known as: 12 weeks of high intensity interval training or combined exercise
Combined exerciseHigh intensity interval training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reval

Diepenbeek, 3590, Belgium

Location

Related Publications (3)

  • 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.

    PMID: 26418222DERIVED

  • 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.

    PMID: 25666356DERIVED

  • 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.

    PMID: 25264868DERIVED

MeSH Terms

Conditions

Multiple SclerosisInsulin Resistance

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Inez Wens, M.Sc.

    Reval/Biomed, Hasselt University

    PRINCIPAL INVESTIGATOR

  • Bert Opt Eijnde, Ph.D

    Reval/Biomed, Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 3, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

BE(1)