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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12730519
Publication citations
-
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.