Specialty: Renal disorders, Primary sub-specialty: Renal disorders
Conditions
Interventions
Patients meeting all eligibility criteria and providing written informed consent will be randomised after the patient has worn the Accelerometer for 5-7 days and attended a baseline visit. Patients w
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 and over 2. A diagnosis of AAV as classified by the European Medicines Agency Algorithm (EMEA) 3. Remission for at least six months on day of consent (defined by BVAS=0 on day of consent AND prednisolone dose <7.5mg for 6 months) 4. Significant fatigue levels (MFI-20 general fatigue score 14 or higher) 5. Ability to understand and complete questionnaires
Exclusion criteria
Exclusion criteria: 1. Inability to provide informed consent 2. Inability or unwillingness to undertake physical activity 3. Co-morbidities identified by clinician, considered to contra-indicate an increase in physical activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Eligibility rate is measured by calculating the % of people with AAV who are eligible for the study. List of all AAV sufferers at site is collected at study start and reviewed by clinician. Those who fulfil inclusion/exclusion criteria will be potentially eligible and invited to baseline clinic. Eligibility is confirmed on study CRFs at baseline clinics, and eligible patients will be offered trial entry. Rates will be calculated once recruitment completed. 2. Recruitment rate is measured by the % of eligible people who enter the study. The percentage of potentially eligible people who do not wish to attend baseline clinic appointments are calculated, as well as the rate of those who do attend clinics and do not wish to participate in the study. This will be calculated at recruitment end. 3. Retention rate is measured as the percentage of randomised patients who complete the trial at trial end 4. Drop-out rate is measured bas the percentage of people who entered the trial but who dropped out of the study before trial end at trial end 5. Acceptability of collecting outcome measures is measured by participation in focus groups which take place in months 9-12 6. Quality of completion of questionnaires is measured by the monitoring the missing data items within completed questionnaires and calculating whether they are completed accurately enough for meaningful analysis 7. Safety of the intervention is measured by collecting information regarding Adverse Events during follow up clinic appointments, at 12 and 24 weeks 8. Patient acceptability of the intervention is measured by participation in focus groups which take place in months 9-12. 9. Utility of operational manual is assessed through formal feedback from the physiotherapists using the manual on an ongoing basis throughout the study, and the manual ad | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life and fatigue are measured using a number of QoL questionnaires (EQ5D, SF36, IPAQ, MFI-20, BRAF-MDQ, Pittsburgh Sleep Index, HADS, Brief Cope Questionnaire, AAV-PRO) at baseline and 12, 24 and 52 weeks. 2. Muscular or bony injury requiring medical attention is assessed on study CRFs during follow up appointments at 12 and 24 weeks 3. Disease relapse is assessed on study CRFs during follow up appointments at 12 and 24 weeks 4. Increase in fatigue is assessed using the MFI-20 and BRAF-MDQ during follow up appointments at 12 and 24 weeks, and in the postal questionnaires follow-up at 52 weeks | — |
Countries
United Kingdom
Contacts
Public ContactLorraine Harper
Outcome results
None listed