Frailty Intervention Trial In End-Stage Patients on Dialysis
Research type
Research Study
Full title
Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS) – a feasibility study
IRAS ID
216689
Contact name
Adnan Sharif
Contact email
Sponsor organisation
Research and Governance lead
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Frailty is the clinical condition of decline across multiple body systems and where these body systems fail when presented with a stressor event, such as infection or surgery. US data suggests that frail haemodialysis and kidney transplant patients have poorer outcomes when compared with non-frail peers, however UK and US haemodialysis and transplantation outcomes differ significantly.
The aims of the FITNESS study are threefold: 1) to determine which frailty assessment tool performs best in a UK haemodialysis population, 2) to quantify the prevalence and outcomes of frailty amongst this population, and 3) to assess the feasibility and effectiveness of a clinical intervention trial in frail haemodialysis patients.
To achieve this, we propose to first investigate the prevalence of frailty amongst the haemodialysis population at our centre. This will be achieved by clinical examination at each patient’s haemodialysis centre using simple tools used to quantify the degree of frailty in an individual. Patients will then be remotely followed up, using data linkage from hospital electronic records over a period of five years to ascertain whether there are any differences in outcomes between frail and non-frail patients.
We will then study whether a large scale lifestyle intervention trial is feasible and effective in modifying frailty. 50 ‘pre-frail’ patients will be randomly assigned to an ‘active’ or ‘passive’ group. The active patients will receive a series of motivational interviews over 6 months from a dietician and physiotherapist in an attempt to modify their lifestyle and thus improve their frailty score. Passive patients will receive standard care, including dietician input as standard for dialysis patients and physiotherapy if indicated. Frailty scores for all participants will be serially checked at four time points up to 6 months. Patients will then be followed up electronically for 60 months.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
17/WM/0381
Date of REC Opinion
25 Oct 2017
REC opinion
Favourable Opinion