Clinical trial NCT04860440: A Study of Wrist Worn Accelerometers in End-Stage Renal Disease
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).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
End Stage Renal Disease on Dialysis
Frailty
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2021-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability
timeFrame: 7 days
Secondary outcomes:
measure: Measurement of physical activity by the accelerometer
timeFrame: 7 days
measure: Fried Frailty Phenotype (no units)
timeFrame: 1 day
measure: Grip strength (in kilograms)
timeFrame: 1 day
measure: Walking speed (in seconds measured over 15 feet)
timeFrame: 1 day
measure: Clinical Frailty Scale (no units)
timeFrame: 1 day
measure: 10 Point Cognitive Screener (no units)
timeFrame: 1 day
measure: 4AT Assessment Tool of Cognitive Impairment (no units)
timeFrame: 1 day
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: James Richards
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: James A Richards
role: PRINCIPAL_INVESTIGATOR
References: