NCT03923972

Brief Summary

This study evaluates possible barriers to physical activity/exercise training for patients with chronic kidney disease in Europe. The study's aim is to investigate structural problems and attitudes at different levels of care. Both a systemic and individual approach are applied. Barriers due to health care organisation and reimbursement policies will be investigated in the health care system and at the renal unit. Perceived benefits of physical activity and personal attitudes towards a healthy lifestyle will be investigated in nephrologists and renal nurses. Patients' health related quality of life, attitudes and perceived availability will be explored.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

3.4 years

First QC Date

March 12, 2019

Last Update Submit

October 31, 2021

Conditions

Keywords

physical activityexercise trainingsurveys and questionnaireschronic kidney diseasedialysiskidney transplantationhealth care facilities

Outcome Measures

Primary Outcomes (5)

  • Exercise prescription to patients with chronic kidney disease

    Number of units with exercise prescription plans

    through study completion, an average of one year

  • Nephrologists exercise habits

    Number of nephrologists participating in regular exercise

    through study completion, an average of one year

  • Renal nurses exercise habits

    Number of renal nurses participating in regular exercise

    through study completion, an average of one year

  • CKD patients exercise habits

    Number of patients who have received prescription of exercise training

    through study completion, an average of one year

  • Health related quality of life in patients with CKD

    SF-36 quality of life questionnaire

    through study completion, an average of one year

Study Arms (4)

Patients with chronic kidney disease

Patients with non dialysis dependent chronic kidney disease stages 4-5, patients on renal replacement therapy treated with peritoneal dialysis or hemodialysis, patients after renal transplantation

Nephrologists

physicians treating patients with chronic kidney disease

Nephrology nurses

nurses caring for patients with chronic kidney disease

heads of Nephrology departments

Medical and/or administrative directors of e nephrology department with knowledge of the healthcare system in their country

Eligibility Criteria

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

Patients with chronic kidney disease comprising non dialysis dependent patients with stages 4-5, patients on peritoneal or hemodialysis, after a renal transplantation, physicians and nurses involved in the treatment of these patients and the director responsible for managing the nephrology department.

You may qualify if:

  • all adult patients with non-dialysis dependent chronic kidney disease, peritoneal dialysis, hemodialysis, renal transplantation
  • all active physicians in the department of nephrology involved in patient care
  • all active nurses in the department of nephrology involved in patient care
  • all heads of nephrology departments

You may not qualify if:

  • children
  • no physical disability making it impossible to conduct exercise training
  • no mental disability or language problem making it impossible to understand and fill in a questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hallands sjukhus

Halmstad, Sweden

RECRUITING

Ljungby lasarett

Ljungby, Sweden

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Carmine Zoccali, MD, PhD

    CNR-IFC Clinical epidemiology of renal diseases and hypertension, Reggio Cal.

    STUDY CHAIR
  • Naomi Clyne, MD, PhD

    Clinical Sciences, Lund, Lund University and Skåne University Hospital

    STUDY CHAIR
  • Carmine Zoccali, MD, PhD

    CNR-IFC Clinical epidemiology of renal diseases and hypertension

    PRINCIPAL INVESTIGATOR
  • Francesca Malamacci, MD, PhD

    Azienda Ospedaliera Bianchi-Melacrino-Morelli di Reggio Calabria

    PRINCIPAL INVESTIGATOR
  • Naomi Clyne, MD, PhD

    Clinical Sciences, Lund, Lund University and Skåne University Hospital

    PRINCIPAL INVESTIGATOR
  • Evangelia Kouidi, MD, PhD

    Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR
  • Amaryllis VanCraenenbroeck, MD, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR
  • Adamasco Cupisti, MD, PhD

    University of Pisa

    PRINCIPAL INVESTIGATOR
  • Clemens Grupp, MD, PhD

    Sozialstiftung Bamberg

    PRINCIPAL INVESTIGATOR
  • Mai Rosenberg, MD, PhD

    University of Tarttu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Clyne, MD, PhD

CONTACT

Evangelia Kouidi, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 12, 2019

First Posted

April 23, 2019

Study Start

May 15, 2019

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

November 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations