The prevalence and associations of fatigue in Systemic Lupus Erythematosus (SLE) and the effects of aerobic exercise on fatigue and sleep patterns in SLE

ISRCTN	ISRCTN71091471
DOI	https://doi.org/10.1186/ISRCTN71091471
Protocol serial number	T0519
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr David D'Cruz
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To test the efficacy of a graded aerobic exercise programme in treating fatigue in systemic lupus erythematosus.
Ethics approval(s)	Ethical approval was obtained from the district research ethics committee and all subjects gave valid and informed consent before entering the study.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Self-rated clinical global impression change score, measured at baseline and three months.
Key secondary outcome measure(s)	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
Completion date	01/01/2003

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	93
Key inclusion criteria	Female patients fulfilling American College of Rheumatology (ACR) classification for SLE
Key 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
Date of first enrolment	01/01/2001
Date of final enrolment	01/01/2003

The Lupus Research Unit

London
SE1 7EH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2003		Yes	No