A Study of Wrist Worn Accelerometers in End-Stage Renal Disease (W-WARD)

A Feasibility Study of a Wrist Worn Accelerometer to Characterise the Physical Activity of Patients With End-stage Renal Disease (W-WARD Study).

The kidneys are important at getting rid of toxins and excess water from the body. If they fail, then toxins and excess water builds up within the body. Kidney failure is treated by either giving patients a new kidney (a transplant) or by removing the toxins and fluid from the body by the process of dialysis.

The investigators' aim is to personalise the care given to patients with kidney failure, and as such, they have started measuring the fitness of patients with kidney failure, who either already require dialysis or may need dialysis in the near future. This is currently done in a number of ways including measuring how strong their grip is, assessing their walking speed and asking questions about how difficult they find certain activities.

In the future, the investigators think that this will allow targeted treatments to help improve their fitness and potentially identify any problems earlier.

Current approaches to measuring activity and fitness have limitations and in particular may over- or underestimate the level of the physical activity. To over come these limitations, participants will be asked to wear an activity tracker (called an accelerometer) on for a week. Readings from the accelerometer will be compared against the other markers of fitness and activity to see if they are comparable. It will also be noted whether patients are prepared to wear the device for 7 days (compliance).

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases; Frailty; End Stage Renal Disease on Dialysis
• Intervention / Treatment: Device: GeneActiv wrist worn accelerometer

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: James A Richards; Phone Number: 01223 245 151; Email: James.richards@addenbrookes.nhs.uk

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • James Richards
    • Contact: James A Richards, MBChB PhD; Phone Number: 01223 245151
    • Contact: Subhankar Paul, MBBS MRCS; Phone Number: 01223 245151
    • Principal Investigator: James A Richards

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Low clearance pre-dialysis patients referred to the Low Clearance Clinic and / or who have commenced on haemodialysis

Description

Inclusion Criteria:

1. Aged over 18 years with low clearance pre-dialysis and referred to the Low Clearance Clinic with estimated Glomerular Filtration Rate (eGFR) less than 20 ml/min/1.73m and / or commenced on haemodialysis
2. Able to give informed consent

Exclusion Criteria:

1. Significant resting tremor of any aetiology or severe Parkinson's Disease
2. Immobile
3. Arteriovenous fistulas in both arms
4. Any scheduled inpatient treatment or day case treatment in next 7 days.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
End-Stage Renal Disease on haemodialysis; Wearing accelerometer (fitness tracker) for 7 days.	Device: GeneActiv wrist worn accelerometer; Wrist worn device worn for 7 days
Low clearance pre-dialysis patients; Wearing accelerometer (fitness tracker) for 7 days.	Device: GeneActiv wrist worn accelerometer; Wrist worn device worn for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	The acceptability of physical activity measures in frailty assessment in patients from the low clearance and dialysis clinic as determined by the percentage of time, device worn during the 7-day period.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of physical activity by the accelerometer	Measurement of physical activity by the accelerometer (no units)	7 days
Fried Frailty Phenotype (no units)	Fried Frailty Phenotype (no units)	1 day
Grip strength (in kilograms)	Grip strength (in kilograms)	1 day
Walking speed (in seconds measured over 15 feet)	Walking speed (in seconds measured over 15 feet)	1 day
Clinical Frailty Scale (no units)	Clinical Frailty Scale (no units)	1 day
10 Point Cognitive Screener (no units)	10 Point Cognitive Screener (no units)	1 day
4AT Assessment Tool of Cognitive Impairment (no units)	4AT Assessment Tool of Cognitive Impairment (no units)	1 day

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: University of Cambridge
• Investigators: Principal Investigator: James A Richards, Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (ACTUAL): April 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Frailty
• Other Study ID Numbers: W-WARD2020v1

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