Frailty Intervention Trial in End-Stage Patients on Dialysis (FITNESS)

Frailty Intervention Trial in End-Stage Patients on Dialysis: A Feasibility Study

The proposed investigation for this study aims to; 1) understand the prevalence and outcomes associated with frailty among haemodialysis patients; 2) ascertain the best frailty assessment tool for haemodialysis patients, and; 3) design a clinical study to explore the feasibility of facilitating, recruiting and executing a multi-disciplinary clinical and psychological intervention to improve frailty status among haemodialysis patients.

Work package 1: Firstly, there is a need to understand the prevalence and spectrum of frailty in a UK haemodialysis cohort and what impact frailty has for haemodialysis patients. To investigate this, the investigators will approach every patient on haemodialysis within the local catchment of haemodialysis units and, after informed consent, clinically phenotype their frailty status (pre- and post-haemodialysis for calculation of variability). The frailty phenotyping will encompass a number of frailty assessments (including the Edmonton Frail Scale, Clinical Frailty Scale from Rookwood score and Fried Frailty scale) to identify the ideal frailty assessment tool. All patients in this observational cohort study will be prospectively monitored for clinical/biochemical outcomes using an informatics-based approach for up to 60 months.

Work package 2: Building upon the work conducted in work package 1, work package 2 will aim to recruit 50 patients clinically phenotyped with pre-frailty from work package 1 into a feasibility study exploring a multi-disciplinary intervention to improve frailty status. Eligible patients, after informed consent, will be randomised into active or passive intervention. The active intervention will involve a dietitian and physiotherapist who have been trained and accredited with cognitive behavior intervention, utilising established behavioral intervention frameworks, to deliver a multi-disciplinary clinical intervention targeting multiple components of frailty.

The FITNESS project will therefore answer some important unanswered questions regarding frailty among the haemodialysis population and help in the design of a large multi-disciplinary intervention study if deemed feasible.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Activity; Hemodialysis Complication; Nutritional Deficiency
• Intervention / Treatment: Behavioral: Multi-disciplinary intervention

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2WB
      • University Hospitals Birmingham NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• On hemodialysis

Exclusion Criteria:

• Inability to give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Standard of care
Active Comparator: Multi-disciplinary intervention arm; Multi-disciplinary intervention on frailty parameters including input from dietitian, physiotherapist and medical team	Behavioral: Multi-disciplinary intervention; Participants in the intervention group will receive a multifactorial, interdisciplinary, treatment program intended to target pre-frailty for a 4-month period following randomization (physical meetings at 2-monthly time points with telephone consultations between meetings). The interventions will be individually tailored to each participant based on their frailty characteristics at baseline and amended if other problems are identified during the intervention program. This intervention team will consist of a renal dietitian and physiotherapist, both of whom will be trained and accredited in behavioural therapy intervention skills, and will focus on improving nutritional status and physical strength through resistance exercise training. They will be supported by a Clinical Research Fellow who will provide additional medical assessment to determine any reversible medical causes of frailty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of frailty intervention study in haemodialysis patients	Feasibility of undertaking a full scale clinical intervention trial targeting frail haemodialysis patients	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frailty status	Change in frailty score between baseline and end of study	6-months
Mortality	Difference in mortality episodes between randomised arms	6-months
Hospitalisation	Difference in episodes of hospitalisation between randomised arms	6-months

Collaborators and Investigators

• Sponsor: Adnan Sharif

Publications and helpful links

General Publications

• Anderson BM, Dutton M, Day E, Jackson TA, Ferro CJ, Sharif A. Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS): study protocol for a randomised controlled trial. Trials. 2018 Aug 24;19(1):457. doi: 10.1186/s13063-018-2842-x.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): June 15, 2019
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: February 25, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Frailty; Malnutrition
• Other Study ID Numbers: FITNESS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No