NCT02050035

Brief Summary

The purpose of this study is to investigate the effects of 12 weeks of aerobic exercise training on blood vessel function in Stages 1-4 Chronic Kidney Disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

January 28, 2014

Last Update Submit

August 29, 2017

Conditions

Chronic Renal Insufficiency

Keywords

Exercise TherapyEndothelium, vascularBlood Vessels

Outcome Measures

Primary Outcomes (1)

  • Endothelial Function

    Conduit artery endothelial function assessed by brachial artery flow mediated dilation; Microvascular endothelial function assessed by cutaneous vasodilation in response to local heating measured by microdialysis and laser Doppler flowmetry.

    Change from baseline at 12 weeks

Secondary Outcomes (12)

  • Microvascular function

    Change from baseline at 12 weeks

  • Oxidative stress contribution to vascular dysfunction

    Change from baseline at 12 weeks

  • Endothelial cell oxidative stress

    Changes from baseline at 12 weeks

  • Plasma Oxidized Low Density Lipoprotein

    Change from baseline at 12 weeks

  • F2-isoprostanes

    Change from baseline at 12 weeks

  • +7 more secondary outcomes

Study Arms (3)

CKD Aerobic Exercise Training

EXPERIMENTAL

Chronic Kidney Disease participants randomly allocated to the CKD Exercise arm will receive 12 weeks of Aerobic Exercise Training three times per week.

Other: Aerobic Exercise Training

CKD Control

NO INTERVENTION

Chronic Kidney Disease participants allocated to the the CKD Control arm will receive their standard routine care over a 12 week period.

Healthy Control

NO INTERVENTION

Healthy participants will act as comparators, they will undergo baseline testing only and will not receive an intervention.

Interventions

Aerobic Exercise TrainingOTHER

Supervised outpatient moderate to vigorous aerobic training at 60% - 85% heart rate reserve, carried out for 45 minutes, three times per week over a twelve week period.

CKD Aerobic Exercise Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CKD Exercise and CKD Control Arms: Stage 1 - 4 Chronic Kidney Disease (eGFR 15 - 90 ml/min/1.73m2)
  • Healthy Control Arm: eGFR \> 90 ml/min/1.73m2)

You may not qualify if:

  • History of cardiovascular disease
  • Uncontrolled hypertension
  • Lung disease
  • Liver disease
  • Cancer
  • Immunosuppressant or antiretroviral therapy
  • Current tobacco use
  • Pregnancy
  • Hormone replacement therapy
  • Unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, 19713, United States

Location

Related Publications (1)

  • Kirkman DL, Ramick MG, Muth BJ, Stock JM, Townsend RR, Edwards DG. A randomized trial of aerobic exercise in chronic kidney disease: Evidence for blunted cardiopulmonary adaptations. Ann Phys Rehabil Med. 2021 Nov;64(6):101469. doi: 10.1016/j.rehab.2020.101469. Epub 2021 Oct 26.

    PMID: 33316435DERIVED

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

  • David Edwards, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffessor

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

July 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 31, 2017

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations

US(1)