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Completed

NCT Number: NCT02392299

Risk of Falling in Chronic Kidney Disease 5

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Monklands Renal Unit, Airdrie, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Falls incidence

    Time frame: One year

Secondary outcomes

  1. Frailty components

    Time frame: baseline

    muscle strength, balance, gait speed, body composition

Other outcomes

  1. Cardiovascular Function

    Time frame: baseline

    blood pressure, baroreceptor reflexes

Sponsors and collaborators

Lead sponsor

Queen Margaret University

Other

Collaborators

  • British Kidney Patient Association
  • British Renal Society

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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