| Source of record | UK Trials |
| ISRCTN | ISRCTN71091471 |
| Date ISRCTN assigned | 18/07/2002 |
| Local reference number(s) | T0519 |
| Public title | The prevalence and associations of fatigue in Systemic Lupus Erythematosus (SLE) and the effects of aerobic exercise on fatigue and sleep patterns in SLE |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Systemic lupus erythematosus (SLE) |
| Study hypothesis | To test the efficacy of a graded aerobic exercise programme in treating fatigue in systemic lupus erythematosus. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethical approval was obtained from the district research ethics committee and all subjects gave valid and informed consent before entering the study. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Female patients fulfilling American College of Rheumatology (ACR) classification for SLE |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/01/2001 |
| Anticipated end date | 01/01/2003 |
| Status of trial | Completed |
| Target number of participants | 93 |
| Interventions | Allocation using a minimisation protocol to 12 weeks of either graded exercise therapy, relaxation therapy or no intervention |
| Primary outcome measure(s) | Self-rated clinical global impression change score, measured at baseline and three months. |
| 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 |
| Publications | Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=12730519 |
| Sources of funding | Arthritis Research Campaign (UK) |
| Sponsor name | Arthritis Research Campaign (UK) |
| Sponsor details | Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
United Kingdom
S41 7TD |
| Sponsor email | info@arc.org.uk |
| Sponsor website | http://www.arc.org.uk |
| Contact name | Dr David D'Cruz |
| Contact details | The Lupus Research Unit
The Rayne Institute
St Thomas' Hospital
Lambeth Palace Road
London
United Kingdom
SE1 7EH |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN71091471 |
| Date last extracted from ISRCTN register | 17/04/2008 |
