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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedSystemic lupus erythematosus (SLE)
InterventionAllocation using a minimisation protocol to 12 weeks of either graded exercise therapy, relaxation therapy or no intervention
Intervention typeOther
Primary outcome measureSelf-rated clinical global impression change score, measured at baseline and three months.
Secondary outcome measures1. 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 date01/01/2001
Completion date01/01/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants93
Key inclusion criteriaFemale patients fulfilling American College of Rheumatology (ACR) classification for SLE
Key exclusion criteria1. 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 enrolment01/01/2001
Date of final enrolment01/01/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Lupus Research Unit
London
SE1 7EH
United Kingdom

Sponsor information

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom

Phone +44 (0)300 790 0400
Email enquiries@arthritisresearchuk.org
Website http://www.arc.org.uk
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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