Contact information
Type
Scientific
Primary contact
Dr L Harper
ORCID ID
Contact details
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
+44 (0)121 627 1627
l.harper@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265134386
Study information
Scientific title
Acronym
Study hypothesis
Exercise training and psychological support is beneficial in improving health status and exercise capacity in patients with vasculitis.
1. What are the effects on exercise tolerance and health status of an 8 week programme of exercise training in patients with vasculitis?
2. What are the effects of an 8 week programme of psychological support on psychological profile and health status in patients with vasculitis?
3. Is there a difference in efficacy between exercise training and psychological support in terms of improvement in health status and compliance with the intervention?
4. Is there an additive effect of successively combining both treatments and does the order in which these are administered affect the magnitude of the response?
Ethics approval
Not provided at time of registration
Study design
Randomised Crossover Study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular: Vasculitis
Intervention
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 support following which they will crossover and receive the alternative treatment for a further period of 8 weeks. All patients will undergo a 4 week run in period during which time measurements will be made of lung function, exercise capacity, respiratory muscle function, health status and psychological functioning. These measurements will be repeated at the end of the first period of the crossover study (after 8 weeks) and completion of the second period of the study (after 16 weeks). Of these parameters regular measurement of lung function and respiratory muscle function constitute a part of normal clinical practice.
Each intervention (exercise training and psychological support) will be conducted over a period of weeks and patients will be required to attend the hospital on a weekly basis for a period of approximately one and a half hours for psychological support and twice weekly for exercise training sessions.
As of May 2008, please note that the study was never initiated.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
28/11/2003
Overall trial end date
28/11/2008
Reason abandoned (if study stopped)
Study was never initiated
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
46
Participant 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.
Recruitment start date
28/11/2003
Recruitment end date
28/11/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list