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

Sponsor
Cambridge University Hospitals NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04860440
Collaborator
University of Cambridge (Other)
40
1
8
5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: GeneActiv wrist worn accelerometer

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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).
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Measurement of physical activity by the accelerometer [7 days]

    Measurement of physical activity by the accelerometer (no units)

  2. Fried Frailty Phenotype (no units) [1 day]

    Fried Frailty Phenotype (no units)

  3. Grip strength (in kilograms) [1 day]

    Grip strength (in kilograms)

  4. Walking speed (in seconds measured over 15 feet) [1 day]

    Walking speed (in seconds measured over 15 feet)

  5. Clinical Frailty Scale (no units) [1 day]

    Clinical Frailty Scale (no units)

  6. 10 Point Cognitive Screener (no units) [1 day]

    10 Point Cognitive Screener (no units)

  7. 4AT Assessment Tool of Cognitive Impairment (no units) [1 day]

    4AT Assessment Tool of Cognitive Impairment (no units)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 James Richards Cambridge United Kingdom CB2 0QQ

Sponsors and Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • University of Cambridge

Investigators

  • Principal Investigator: James A Richards, Cambridge University Hospitals NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James Richards, Academic Clinical Lecturer & Senior Clinical Fellow in HPB & Transplantation Surgery, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT04860440
Other Study ID Numbers:
  • W-WARD2020v1
First Posted:
Apr 27, 2021
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2021