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Status unknownNCT04860440W-WARDUpdated Apr 27, 2021

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

An observational study in Chronic Kidney Diseases, End Stage Renal Disease on Dialysis and Frailty, sponsored by Cambridge University Hospitals NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.

Sponsored by Cambridge University Hospitals NHS Foundation Trust · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Chronic Kidney Diseases
  • End Stage Renal Disease on Dialysis
  • Frailty
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 40 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 167 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • End-Stage Renal Disease on haemodialysis

    Wearing accelerometer (fitness tracker) for 7 days.

    Device: GeneActiv wrist worn accelerometer

  • Low clearance pre-dialysis patients

    Wearing accelerometer (fitness tracker) for 7 days.

    Device: GeneActiv wrist worn accelerometer

Interventions

  • DeviceGeneActiv wrist worn accelerometer

    Wrist worn device worn for 7 days

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days

Secondary outcomes

  1. Measurement of physical activity by the accelerometer

    Measurement of physical activity by the accelerometer (no units)

    Time frame: 7 days

  2. Fried Frailty Phenotype (no units)

    Fried Frailty Phenotype (no units)

    Time frame: 1 day

  3. Grip strength (in kilograms)

    Grip strength (in kilograms)

    Time frame: 1 day

  4. Walking speed (in seconds measured over 15 feet)

    Walking speed (in seconds measured over 15 feet)

    Time frame: 1 day

  5. Clinical Frailty Scale (no units)

    Clinical Frailty Scale (no units)

    Time frame: 1 day

  6. 10 Point Cognitive Screener (no units)

    10 Point Cognitive Screener (no units)

    Time frame: 1 day

  7. 4AT Assessment Tool of Cognitive Impairment (no units)

    4AT Assessment Tool of Cognitive Impairment (no units)

    Time frame: 1 day

07

Study locations

1 site
  • James Richards
    Cambridge, CB2 0QQ, United Kingdom
    • James A Richards, MBChB PhD · Contact · 01223 245151
    • Subhankar Paul, MBBS MRCS · Contact · 01223 245151
    • James A Richards · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04860440
Lead sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
University of Cambridge
Responsible party
James Richards (Academic Clinical Lecturer & Senior Clinical Fellow in HPB & Transplantation Surgery, Cambridge University Hospitals NHS Foundation Trust) — Principal investigator
First posted
Apr 27, 2021
Start date
Jul 2021 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Mar 2022 (estimated)
Last update
Apr 27, 2021

Study contacts

James A Richards
Contact
James.richards@addenbrookes.nhs.uk
01223 245 151
James A Richards
principal investigator · Cambridge University Hospitals NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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