Resistance Exercise Training in Chronic Kidney Disease

Effect of Resistance Exercise Training on Endothelial Function and Cardiovascular Risk Factors in Patients With Chronic Kidney Disease

The investigators aim to evaluate the feasibility of a resistance exercise training program among individuals with CKD and its impact on endothelial and vascular function.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Behavioral: Resistance exercise training

Detailed Description

Resistance exercise training has been shown to improve cardiovascular health including endothelial function in general populations, but studies in patients with chronic kidney disease (CKD) are limited. The investigators aim to evaluate the feasibility and acceptability of a resistance exercise training program among individuals with CKD and its impact on endothelial and vascular function as measured by brachial artery flow-mediated dilation, pulse-wave velocity and carotid artery stiffness. To accomplish this goal the investigators propose to conduct a 12-week pilot randomized controlled trial of twice a week resistance exercise training among 32 adults with CKD. The results of this study will inform the design and implementation of a larger trial evaluating the impact of resistance exercise training on adverse outcomes in patients with CKD including CKD progression.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• CKD stage 3 or 4 (eGFR 15-60 ml/min/1.73m2)

Exclusion Criteria:

• Currently institutionalized
• Kidney transplant or dialysis
• NY Heart Association class 3-4 heart failure
• Dementia or cognitive impairment
• Unstable angina or coronary revascularization within the last 3 months
• Uncontrolled arrhythmia
• Severe chronic lung disease
• Orthopedic, neurologic or other condition that would preclude resistance exercise training
• Pregnancy
• Uncontrolled hypertension (systolic > 160 mmHg and diastolic >90 mmHg)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance exercise training program; Eight exercises will be used to include large upper and lower body muscle groups. The baseline 1 repetition maximum (RM) will be used to set initial training loads. All exercise sessions will be performed under the supervision of an exercise physiologist. Vital signs and body weight will be recorded before each session. The workload during training will be adjusted to reflect 80% of the most recent 1 RM (approximately 8-12 RM set). In addition, patients' workloads will be progressively increased if the patients can lift the weight more than 12 repetitions. Participants will perform three sets of 8-12 repetitions on each machine per session.	Behavioral: Resistance exercise training; 12-week resistance exercise training program, 2 times per week, 45 min per session. Eight exercises will be used to include large upper and lower body muscle groups (leg press, leg extension, leg curl, chest press, shoulder extension, biceps curl, abdominal crunch and back extension). The baseline one repetition maximum will be used to set initial training loads.
No Intervention: Control; Participants randomized to the control group will be offered an educational brochure regarding exercise published by the NKF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function	Measured by brachial artery flow-mediated dilation (FMD)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular function	Measured by pulse wave velocity	3 months
Carotid artery stiffness	Measured by non-invasive ultrasound	3 months
Self-reported physical activity	Assessed by the MESA (Multiethnic Study of Atherosclerosis) Typical Week Physical Activity Survey	3 months
Objectively measured physical activity	Assessed by a physical activity monitor (ActiGraph GT3X+)	3 months
Systolic blood pressure	Measured using standard procedures	3 months
Serum LDL-cholesterol	Measured using standard procedures	3 months
Serum HDL-cholesterol	Measured using standard procedures	3 months
Muscle strength	Assessed by the amount of weight lifted in a single chest press and leg press (1 RM).	3 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Ana C Ricardo, MD, Assistant Professor of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2016-0421; K23DK094829 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No