A Single-blinded, Controlled, Multi-centre Study of Effec... | NCT01065090

Studies
A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis

NCT01065090

Sponsor

Biogen

Status

Completed

Last Update Posted

Apr 13, 2015Estimated

Enrollment

38Actual

Phase

Not provided

Conditions

Exercise

Interventions

Not provided

Countries

Australia
Denmark
Finland
New Zealand
Norway
Sweden

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

Apr 2015

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

Jun 2010

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Feb 8, 2010

First Submission Date that Met QC Criteria

Feb 8, 2010

First Posted Date

Feb 9, 2010Estimated

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

Apr 9, 2015

Last Update Posted Date

Apr 13, 2015Estimated

Name	Class
Biogen Idec A/S	UNKNOWN

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 primary objective of the investigation is to determine whether the addition of exercise (resistance training or modified physiotherapy) improves functional capacity in Multiple Sclerosis (MS) participants undergoing Disease Modifying Therapy (DMT) treatment. We hypothesize that the Progressive Resistance Training (PRT) will improve functional capacity without increasing the risk of relapses in participants undergoing standard DMT treatment. The secondary objectives are to determine whether exercise (resistance training or physiotherapy) improves fatigue, mood and Quality of Life (QoL) in MS participants undergoing DMT treatment. Also as a secondary objective, the study aims at determining whether exercise (resistance training or modified physiotherapy) has an impact on Expanded Disability Status Scale (EDSS), time to first relapse, number of relapse free participants, and immunological factors. We hypothesize that the exercise (resistance training) will improve fatigue, mood and QoL and that an impact on immunological factors will be seen in participants even though they are undergoing standard DMT treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
training		one group will receive resistance training and one group the normal physiotherapeutic treatment
physiotherapy		one group will receive resistance training and one group the normal physiotherapeutic treatment

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of muscle strength	Measured by chair stand test	Baseline, 12 months, 15 months and 18 months.

Secondary Outcomes

Measure	Description	Time Frame
Changes of speed of walking	Measured by 6 min walk test, Symbol Digit Modalities Test (SDMT), Quality of Life (QoL, SF26, physical part) and Multiple Sclerosis Walking Scale (MSWS)	Baseline, 12 months and 18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Age > 18 years and age < 65 years at screening
Relapsing Remitting Multiple Sclerosis (RRMS) diagnosis according to McDonald Criteria
Subjects who have been on Avonex treatment for 3-6 months prior to screening
A signed informed consent form (ICF) is obtained before any study activity
EDSS > 1.5 and < 5 at Screening with at least a score of 1 in pyramidal function
Are able to walk at least 100 meters
Are able to transport themselves to and from the training facility

Key Exclusion Criteria:

Suffer from dementia, alcoholism or if they use pacemaker
Have any serious medical co-morbidities like cardiovascular, respiratory, orthopedic or metabolic diseases
Have had a MS relapse within an eight week period prior to the study start
Are pregnant
Have trained systematic resistance training for one day or more each week in the prior 3 months before study start.
Only able to participate in less than 70% of the planned training sessions.
Suffers from major depression

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Patients on AVONEX 3-6 months after treatment initiation

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Coordinating Research Site		NSW			Australia
Research Site