NCT01718392

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable multiple-sclerosis

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, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

October 23, 2012

Last Update Submit

November 22, 2016

Conditions

Multiple Sclerosis

Keywords

combined traininginsulin resistance

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity (insulin profile)

    glucose and insulin concentration measurements in blood

    change from baseline to 24 weeks

Secondary Outcomes (10)

  • aerobic capacity

    change from baseline to 24 weeks

  • aerobic capacity - lactate concentrations

    change from baseline to 24 weeks

  • cytokine profile

    change from baseline to 24 weeks

  • walking performance

    change from baseline to 24 weeks

  • Self-reported measures

    Change from baseline to 24 weeks

  • +5 more secondary outcomes

Study Arms (2)

Training

EXPERIMENTAL

24 weeks combined exercise programme (supervised)

Behavioral: Training

Control

NO INTERVENTION

sedentary/habitual lifestyle

Interventions

TrainingBEHAVIORAL
Also known as: 24 weeks combined exercise programma (supervised)
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

MeSH Terms

Conditions

Multiple SclerosisInsulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

  • Inez Wens, M.Sc.

    Reval/Biomed, Hasselt University

    PRINCIPAL INVESTIGATOR

  • Bert Op't 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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 31, 2012

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

September 1, 2013

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

BE(1)