Condition category
Musculoskeletal Diseases
Date applied
18/07/2002
Date assigned
18/07/2002
Last edited
05/01/2011
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 David D'Cruz

ORCID ID

Contact details

The Lupus Research Unit
The Rayne Institute
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

T0519

Study information

Scientific title

Acronym

Study hypothesis

To test the efficacy of a graded aerobic exercise programme in treating fatigue in systemic lupus erythematosus.

Ethics approval

Ethical approval was obtained from the district research ethics committee and all subjects gave valid and informed consent before entering the study.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Systemic lupus erythematosus (SLE)

Intervention

Allocation using a minimisation protocol to 12 weeks of either graded exercise therapy, relaxation therapy or no intervention

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Self-rated clinical global impression change score, measured at baseline and three months.

Secondary outcome measures

1. Assessments of symptoms, measured at baseline and three months
2. Functional capacity, measured at baseline and three months
3. Fitness, measured at baseline and three months

Overall trial start date

01/01/2001

Overall trial end date

01/01/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Female patients fulfilling American College of Rheumatology (ACR) classification for SLE

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

93

Participant exclusion criteria

1. Evidence of active severe myositis, nephritis, neurological involvement or cardiac or pulmonary disease
2. Pregnant patients
3. Patients under 16 or over 55 years

Recruitment start date

01/01/2001

Recruitment end date

01/01/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Lupus Research Unit
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom
+44 (0)300 790 0400
enquiries@arthritisresearchuk.org

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12730519

Publication citations

  1. Results

    Tench CM, McCarthy J, McCurdie I, White PD, D'Cruz DP, Fatigue in systemic lupus erythematosus: a randomized controlled trial of exercise., Rheumatology (Oxford), 2003, 42, 9, 1050-1054, doi: 10.1093/rheumatology/keg289.

Additional files

Editorial Notes