Clinical trial NCT02392299: Risk of Falling in Chronic Kidney Disease 5
Official title: Frailty, Cardiovascular Function and Risk of Falling in Patients Receiving Haemodialysis Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage 5 Chronic Kidney Disease
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: British Renal Society
name: British Kidney Patient Association
First posted: 2015-03-18
Enrollment: 93
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: Stage 5 Chronic Kidney Disease patients

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Falls incidence
timeFrame: One year
Secondary outcomes:
measure: Frailty components
timeFrame: baseline
Other outcomes:
measure: Cardiovascular Function
timeFrame: baseline
Locations:
city: Airdrie
country: United Kingdom
facility: Monklands Renal Unit
city: Falkirk
country: United Kingdom
facility: Renal Unit
Study officials:
affiliation: Queen Margaret University
name: Tobia Zanotto, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.