Stage 5 Chronic Kidney DiseaseNCT02392299
Risk of Falling in Chronic Kidney Disease 5
An observational study of Stage 5 Chronic Kidney Disease, run by Queen Margaret University at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage 5 Chronic Kidney Disease
- How many people
- 93 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2015to 29 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage 5 Chronic Kidney Disease patients
Who may be able to join
- 18 years old
- Able to write/speak fluent English
- Stable dialysis
Who cannot join
- 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
Show all 10Show fewer
- Critical proximal coronary artery stenosis
- Critical cerebrovascular stenosis
- Pregnancy
- Severe cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Monklands Renal Unit
Airdrie, ML60JS
Renal Unit
Falkirk
About this study
Official title: 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.
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.
- Conditions
- Stage 5 Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls incidence
Measured: One year
Secondary outcomes (1)
Frailty components
muscle strength, balance, gait speed, body composition
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startSep 2015
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage 5 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- British Renal Society, British Kidney Patient Association
- Responsible party
- Principal investigator, P KOUFAKI, Queen Margaret University
- Investigators
- Tobia Zanotto, MSc, Principal investigator, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392299
- Sponsor's protocol ID
- BUR(14/17)
- Status last verified
- Aug 2018
- First submitted
- 12 Mar 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty, Cardiovascular Function and Risk of Falling in Patients Receiving Haemodialysis Treatment
- ClinicalTrials.gov ID
- NCT02392299
- Acronym / sponsor ID
- BUR(14/17)
- Conditions
- Stage 5 Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- British Renal Society, British Kidney Patient Association
- Study start
- Sep 2015
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage 5 Chronic Kidney Disease patients
Key inclusion criteria (3 listed)
- 18 years old
- Able to write/speak fluent English
- Stable dialysis
Key exclusion criteria (10 listed)
- Unstable dialysis and medication treatment
- Lower limb amputees without prothesis
- Unstable cardiac condition
- Suspected or known aneurysm
- Clinically severe left ventricular outflow obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Falls incidence
Time frame: One year
1 secondary outcome
Frailty components
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Derived from this study: PubMed 32169050Zanotto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobia Zanotto, MSc principal investigator
Queen Margaret University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage 5 Chronic Kidney Disease, run by Queen Margaret University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls incidence (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.