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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04860440
Other study ID # W-WARD2020v1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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