Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
03/07/2008
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

N0176140663

Study information

Scientific title

Acronym

Study hypothesis

The study sets out to examine the effect of a targeted aerobic exercise programme in adults with muscular dystrophy who are able to walk at least 10 metres but have some gait impairment. In adults with muscular dystrophy, will a targeted home based progressive exercise programme aimed at improving endurance:
1. Improve mobility (walking distance and speed)
2. Decrease fatigue
3. Improve muscle function (increase muscle strength, speed and power)
4. Improve aerobic fitness
5. Improve perceived performance in specifically targeted functional activities?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal Diseases: Muscular dystrophy (MD)

Intervention

Home based exercise programme vs no home based exercise programme

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary and secondary outcome measures 8 weeks following treatment intervention, and then after another 8 weeks.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2004

Overall trial end date

01/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Adults with Muscular Dystrophy of 16 years and above with some gait impairment and perceived reduced mobility and function that are able to walk at least 10m (aids permitted). Perceived mobility and perceived functional impairment of the lower limb.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20 patients, 20 control patients, total 40

Participant exclusion criteria

Unable to meet the inclusion criteria or those unwilling or unable to undertake the programme

Recruitment start date

01/04/2004

Recruitment end date

01/12/2004

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

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16614008

Publication citations

  1. Results

    Dawes H, Korpershoek N, Freebody J, Elsworth C, van Tintelen N, Wade DT, Izadi H, Jones DH, A pilot randomised controlled trial of a home-based exercise programme aimed at improving endurance and function in adults with neuromuscular disorders., J. Neurol. Neurosurg. Psychiatr., 2006, 77, 8, 959-962, doi: 10.1136/jnnp.2006.087726.

Additional files

Editorial Notes