Rehabilitation in Multiple Sclerosis: Influence of Exerci... | NCT01718392

Studies
Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity

NCT01718392

Sponsor

Hasselt University

Status

Completed

Last Update Posted

Nov 25, 2016Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

Multiple Sclerosis

Interventions

Training

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Oct 23, 2012

First Submission Date that Met QC Criteria

Oct 29, 2012

First Posted Date

Oct 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2016

Last Update Posted Date

Nov 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training	Experimental	24 weeks combined exercise programme (supervised)	Behavioral: Training
Control	No Intervention	sedentary/habitual lifestyle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Training	Behavioral		Training	24 weeks combined exercise programma (supervised)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
insulin sensitivity (insulin profile)	glucose and insulin concentration measurements in blood	change from baseline to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
aerobic capacity	by means of a submaximal endurance test (ergometer)	change from baseline to 24 weeks
aerobic capacity - lactate concentrations	by means of a submaximal endurance test (ergometer) to determine lactate concentrations (mmol/L)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Inez Wens, M.Sc.	Reval/Biomed, Hasselt University	Principal Investigator
Bert Op't Eijnde, Ph.D.	Reval/Biomed, Hasselt University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
REVAL		Diepenbeek		3590	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided