Risk of Falling in Chronic Kidney Disease 5

Stage 5 Chronic Kidney Disease Clinical Trial

Official title:

Frailty, Cardiovascular Function and Risk of Falling in Patients Receiving Haemodialysis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392299
• Other study ID #: BUR(14/17)
• Status: Completed
• Start date: September 2015
• Est. completion date: August 29, 2018

Study information

• Verified date: August 2018
• Source: Queen Margaret University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic
• Stage 5 Chronic Kidney Disease

Locations

Country	Name	City	State
United Kingdom	Monklands Renal Unit	Airdrie
United Kingdom	Renal Unit	Falkirk

Sponsors (3)

Lead Sponsor	Collaborator
Queen Margaret University	British Kidney Patient Association, British Renal Society

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular Function	blood pressure, baroreceptor reflexes	baseline
Primary	Falls incidence		One year
Secondary	Frailty components	muscle strength, balance, gait speed, body composition	baseline