The Effect of Exercise Training and Psychological Support in Patients With Small Vessel Vasculitis: a Randomised Crossover Study

Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)0 sites46 target enrollmentSeptember 30, 2004

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
Enrollment: 46
Status: Completed
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

September 30, 2004

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)

•It is proposed to recruit approximately 46 patients (as per sample size calculation) with vasculitis from those attending the Renal Department under Professor Savage/Dr Harper. All patients will have been diagnosed with vasculitis attributable to a range of disorders including microscopic polyangitis, Wegeners granulomatosis, and Churg Strauss syndrome.
•The patients recruited to the study will, as far as possible, be equal in numbers of male and female participants and all will be ambulatory.
•All patients will undergo a medical examination before being enrolled into the study in order to assess their suitability for maximal exercise testing and training.
•Patients receiving a range of medications including oral corticosteroids and immunosuppressants will be included in the study. Use of breathing medication such as bronchodilators will also be permitted. Patients receiving (or having received in the preceding 6 weeks) antibiotics for a respiratory tract infection will not be enrolled onto the study until they are deemed clinically stable.
•During the study, any deterioration in clinical status will be evaluated by the clinical team and the decision on whether to withdraw the patient will then be made. Patients will also be aware that they are free to withdraw from the study at any time without giving prior notice.

•1\. Any subject with orthopaedic problems preventing exercise or primary cardiac disorders will be excluded from the study.
•2\. Female patients will be excluded if they are pregnant.