A Study of Wrist Worn Accelerometers in End-Stage Renal Disease

• Conditions: End Stage Renal Disease on Dialysis; Frailty; Chronic Kidney Diseases
• Interventions: Device: GeneActiv wrist worn accelerometer

• Registration Number: NCT04860440
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-27
• Last Update Posted: 2021-04-27
• Study Start: 2021-07
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low clearance pre-dialysis patients	GeneActiv wrist worn accelerometer	Wearing accelerometer (fitness tracker) for 7 days.
End-Stage Renal Disease on haemodialysis	GeneActiv wrist worn accelerometer	Wearing accelerometer (fitness tracker) for 7 days.

Primary Outcome Measures

Name	Time	Method
Acceptability	7 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

James Richards; 🇬🇧 Cambridge, United Kingdom