Exercise and Vascular Function in Chronic Kidney Disease

NCT ID: NCT02050035

Last Updated: 2017-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-07-31

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.

Detailed Description

The endothelium lines the inside of the blood vessels. A healthy endothelial lining acts as a defense mechanism against vascular injury, mediating vascular tone, vascular structure, and blood-vessel wall relations. Endothelial dysfunction marks the occurrence of cardiovascular injuries and is a critical step in the development of cardiovascular disease. Individuals with Chronic Kidney Disease (CKD) have an increased risk of cardiovascular disease and this may be related to poor blood vessel function. Interventions to improve blood vessel function in CKD are needed. Exercise training has been shown to improve blood vessel function in older subjects and those with heart disease but this has not been investigated in CKD. The National Kidney Foundation recommends exercise for dialysis patients to reduce cardiovascular risk however there is very little data regarding the benefits of exercise in earlier stages of CKD. The purpose of this study is to determine the effect of 12 weeks of exercise training on blood vessel function in moderate to severe CKD.

Conditions

Chronic Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

CKD Aerobic Exercise Training

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

Group Type: EXPERIMENTAL

Aerobic Exercise Training

Intervention Type: OTHER

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 Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aerobic Exercise Training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

David Edwards

Associate Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Edwards, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33316435 (View on PubMed)

Other Identifiers

1R01HL113514-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

364680-6

Identifier Type: OTHER

Identifier Source: secondary_id

KAAP32212114000

Identifier Type: -

Identifier Source: org_study_id