Frailty and end-stage kidney disease Urological and Genital Diseases
Conditions
Interventions
Current interventions as of 21/10/2024:
This study will take the form of a non-blinded pilot randomized controlled trial. Frail adults with end-stage kidney disease (ESKD) will be identified from th
Sponsors
University Hospital Waterford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults >18 years old 2. Patient with ESKD currently receiving haemodialysis or peritoneal dialysis 3. Identified as pre-frail/frail using Freid Frailty Scale
Exclusion criteria
Exclusion criteria: 1. Severe functional disability 2. Cognitive impairment likely to preclude involvement in an exercise program 3. Current participation in an alternative exercise programme 4. Poorly controlled angina or heart failure or coronary event in the last 6 months 5. Receiving palliative care or life expectancy less than 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 21/10/2024: 1. Evaluate the feasibility of conducting a definitive randomized controlled trial. Acceptability, demand, implementation, practicality, integration, adaptation, and expansion measured post completion of the exercise intervention using: 1.1.Semi-structured interviews with ESKD participants in the study 1.2.Focus group with nursing staff from the dialysis unit 2. Change in frailty score measured using the Fried Frailty Scale at baseline, 12 and 18 weeks _____ Previous primary outcome measure: Change in frailty score measured using the Fried Frailty Scale at baseline, 12 and 18 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline,12 weeks,18 weeks: 1. Change in frailty-related biomarkers/inflammatory markers measured using blood C-reactive protein (CRP) and D-Dimer levels 2. Change in dialysis adequacy measured using urea reduction ratio (URR)/Kt/V 3. Change in QoL scores measured using the Montreal Cognitive Assessment (MoCA), The Kidney Disease Quality of Life-Short Form and the Beck Depression Inventory-II 4. Number of treatment-related adverse outcomes – non-serious adverse events (i.e fatigue, pain) collected weekly by participant review; serious adverse events (i.e hospitalization, serious risk of deterioration in patient health, death) collection on occurrence and review event with principal investigator to determine if likely related to intervention | — |
Countries
Ireland
Contacts
Public ContactRobert Casey
Outcome results
None listed