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

ISRCTN	ISRCTN36285326
DOI	https://doi.org/10.1186/ISRCTN36285326
Secondary identifying numbers	N0265134386

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 19/05/2008

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L Harper
Scientific

Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Phone	+44 (0)121 627 1627
Email	l.harper@bham.ac.uk

Study information

Study design	Randomised Crossover Study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	28/11/2003
Completion date	28/11/2008
Reason abandoned (if study stopped)	Study was never initiated

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	46
Key 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.
Key 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.
Date of first enrolment	28/11/2003
Date of final enrolment	28/11/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Selly Oak Hospital

Birmingham
B29 6JD
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

University Hospital Birmingham NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan