The effect of exercise and nutritional supplementation on frailty and dialysis-related measures in end-stage kidney disease patients

Not Applicable

• Conditions: Frailty and end-stage kidney disease; Urological and Genital Diseases

• Registration Number: ISRCTN58806515
• Lead Sponsor: niversity Hospital Waterford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-01-26
• Last Update Posted: 5 February 2024
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 32

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in frailty score measured using the Fried Frailty Scale at baseline, 12 and 18 weeks

Secondary Outcome Measures

Name	Time	Method
The following secondary outcome measures are assessed at baseline,12 weeks,18 weeks:<br>1. Change in frailty-related biomarkers/inflammatory markers measured using blood C-reactive protein (CRP) and D-Dimer levels<br>2. Change in dialysis adequacy measured using urea reduction ratio (URR)/Kt/V<br>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<br>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<br><br>