NCT02392299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

March 12, 2015

Last Update Submit

August 29, 2018

Conditions

Stage 5 Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Falls incidence

    One year

Secondary Outcomes (1)

  • Frailty components

    baseline

Other Outcomes (1)

  • Cardiovascular Function

    baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stage 5 Chronic Kidney Disease patients

You may qualify if:

  • years old
  • Able to write/speak fluent English
  • Stable dialysis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Monklands Renal Unit

Airdrie, ML60JS, United Kingdom

Location

Renal Unit

Falkirk, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32169050DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tobia Zanotto, MSc

    Queen Margaret University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 18, 2015

Study Start

September 1, 2015

Primary Completion

August 29, 2018

Study Completion

August 29, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

GB(2)