Risk of Falling in Chronic Kidney Disease 5

August 29, 2018 updated by: P KOUFAKI, Queen Margaret University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Airdrie, United Kingdom, ML60JS
        • Monklands Renal Unit
      • Falkirk, United Kingdom
        • Renal Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stage 5 Chronic Kidney Disease patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Falls incidence
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty components
Time Frame: baseline
muscle strength, balance, gait speed, body composition
baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Function
Time Frame: baseline
blood pressure, baroreceptor reflexes
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Margaret University

Collaborators

British Renal Society
British Kidney Patient Association

Investigators

  • Principal Investigator: Tobia Zanotto, MSc, Queen Margaret University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

August 29, 2018

Study Completion (Actual)

August 29, 2018

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUR(14/17)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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