CClinicalTrials.gg
CompletedNCT02392299Updated Aug 31, 2018

Risk of Falling in Chronic Kidney Disease 5

An observational study in Stage 5 Chronic Kidney Disease, sponsored by Queen Margaret University. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.

Sponsored by Queen Margaret University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
93
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to explore the relative importance of the frailty and cardiovascular function as potential exercise-modifiable risk factors for falling in patients receiving haemodialysis.

Read the detailed description

Falls and fall-related injuries in elderly people are common worldwide, and ageing populations will further raise the burden and costs. Within the UK, falls have become a major government target, as they have been responsible for increased injuries and hospital admissions in elderly people.

The fall rate amongst patients on haemodialysis (HD) is much greater than in the general population. There are many well established risk factors for falling, many of which are commonly present in patients on HD, including severe loss of muscle mass, high levels of inactivity, co-existing medical conditions and a high number of medications.

Nonetheless, the main cause of health complications and death in Chronic Kidney Disease (CKD) is due to cardiovascular disease. Cardiovascular disease may result in suboptimal regulation of blood pressure and heart rate during exercise, dialysis therapy, body transfers, and general activities of daily living. Associated symptoms such as dizziness, generalised fatigue, and muscular weakness, are commonly reported and may further predispose patients on HD to balance deficits and falls.

Despite the evidence of high falls rates in patients on HD and the growing number of elderly patients, falls and their associated risk factors have received little research attention.

The aim of this study therefore is explore the relative importance of selected exercise-modifiable risk factors for falling amongst patients on HD.

02

Conditions studied

  • Stage 5 Chronic Kidney Disease
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 enrollment of 93 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Queen Margaret University is the lead sponsor of 34 studies on the registry; 6 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

Stage 5 Chronic Kidney Disease patients

Inclusion criteria

  • 18 years old
  • Able to write/speak fluent English
  • Stable dialysis

Exclusion criteria

Exclusion Criteria:

  • Unstable dialysis and medication treatment
  • Lower limb amputees without prothesis
  • Unstable cardiac condition
  • Suspected or known aneurysm
  • Clinically severe left ventricular outflow obstruction
  • Critical mitral stenosis
  • Critical proximal coronary artery stenosis
  • Critical cerebrovascular stenosis
  • Pregnancy
  • Severe cognitive impairment
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
93 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Falls incidence

    Time frame: One year

Secondary outcomes

  1. Frailty components

    muscle strength, balance, gait speed, body composition

    Time frame: baseline

Other outcomes

  1. Cardiovascular Function

    blood pressure, baroreceptor reflexes

    Time frame: baseline

07

Study locations

2 sites
  • Monklands Renal Unit
    Airdrie, ML60JS, United Kingdom
  • Renal Unit
    Falkirk, United Kingdom
08

References and documents

Publications

  • Zanotto T, Mercer TH, van der Linden ML, Rush R, Traynor JP, Petrie CJ, Doyle A, Chalmers K, Allan N, Shilliday I, Koufaki P. The relative importance of frailty, physical and cardiovascular function as exercise-modifiable predictors of falls in haemodialysis patients: a prospective cohort study. BMC Nephrol. 2020 Mar 14;21(1):99. doi: 10.1186/s12882-020-01759-z. PubMed 32169050 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02392299
Lead sponsor
Queen Margaret University
Collaborators
British Renal Society, British Kidney Patient Association
Responsible party
P KOUFAKI (Research Fellow, Queen Margaret University) — Principal investigator
First posted
Mar 18, 2015
Start date
Sep 2015
Primary completion
Aug 29, 2018
Completion
Aug 29, 2018
Last update
Aug 31, 2018

Study contacts

Tobia Zanotto, MSc
principal investigator · Queen Margaret University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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