Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Dawes

ORCID ID

Contact details

School of Biological & Molecular Sciences
Oxford Brookes University
Gypsy Lane Campus
Headington
Oxford
OX3 OB
United Kingdom
+44 (0)1865 483293
hdawes@brookes.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176120461

Study information

Scientific title

Acronym

Study hypothesis

In individuals with multiple sclerosis (MS), who have impaired walking but are able to walk on a treadmill:
1. Can treadmill training improve the speed and/or distance an individual can walk?
2. Can treadmill training improve an individual's general state of well-being?
3. Is treadmill training harmful following multiple sclerosis?

Ethics approval

Not provided at time of registration

Study design

Crossover randomised controlled design study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nervous System Diseases: Multiple sclerosis (MS)

Intervention

One group of patients receives treadmill training for 4 weeks, then no training.
A second group of patients receives no training for 4 weeks, then 4 weeks training.
Each group is assessed at week 5 and week 10.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measures will be functional mobility as measured by the Rivermead Mobility Index, 10 m and 2 min walk tests and fatigue as measured by the Fatigue Severity Scale at each time point.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/03/2003

Overall trial end date

30/11/2003

Reason abandoned

Eligibility

Participant inclusion criteria

12-24 individuals with multiple sclerosis.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

24

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/03/2003

Recruitment end date

30/11/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Biological & Molecular Sciences
Oxford
OX3 OB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17294619

Publication citations

  1. Results

    Newman MA, Dawes H, van den Berg M, Wade DT, Burridge J, Izadi H, Can aerobic treadmill training reduce the effort of walking and fatigue in people with multiple sclerosis: a pilot study., Mult. Scler., 2007, 13, 1, 113-119.

Additional files

Editorial Notes