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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36285326
Enrollment
46
Registered
2004-09-30
Start date
2003-11-28
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular: Vasculitis Circulatory System Vasculitis

Interventions

Patients with vasculitis will be recruited to the study and randomly assigned to two groups. Each group will be randomised to receive an 8 week programme of either exercise training or psychological s

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026