Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes