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 |
| Secondary identifying numbers | T0519 |
- Submission date
- 18/07/2002
- Registration date
- 18/07/2002
- Last edited
- 05/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David D'Cruz
Scientific
Scientific
The Lupus Research Unit
The Rayne Institute
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2001 |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Lupus Research Unit
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom
| Phone | +44 (0)300 790 0400 |
|---|---|
| enquiries@arthritisresearchuk.org | |
| Website | http://www.arc.org.uk |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2003 | Yes | No |
