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

Completed

• Conditions: Cardiovascular: Vasculitis; Circulatory System; Vasculitis

• Registration Number: ISRCTN36285326
• Lead Sponsor: Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified