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

Chronic Kidney Diseases Clinical Trial

— W-WARD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04860440
• Other study ID #: W-WARD2020v1
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: March 2022

Study information

• Verified date: April 2021
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: James A Richards
• Phone: 01223 245 151
• Email: James.richards[@]addenbrookes.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• End Stage Renal Disease on Dialysis
• Frailty
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Device:
• GeneActiv wrist worn accelerometer
Wrist worn device worn for 7 days

Locations

Country	Name	City	State
United Kingdom	James Richards	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

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