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Resistance Exercise Training in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance exercise training
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resistance exercise training program

Control

Arm Description

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.

Participants randomized to the control group will be offered an educational brochure regarding exercise published by the NKF.

Outcomes

Primary Outcome Measures

Endothelial function
Measured by brachial artery flow-mediated dilation (FMD)

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2017
Last Updated
April 15, 2019
Sponsor
University of Illinois at Chicago
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03120416
Brief Title
Resistance Exercise Training in Chronic Kidney Disease
Official Title
Effect of Resistance Exercise Training on Endothelial Function and Cardiovascular Risk Factors in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance exercise training program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants randomized to the control group will be offered an educational brochure regarding exercise published by the NKF.
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Endothelial function
Description
Measured by brachial artery flow-mediated dilation (FMD)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Vascular function
Description
Measured by pulse wave velocity
Time Frame
3 months
Title
Carotid artery stiffness
Description
Measured by non-invasive ultrasound
Time Frame
3 months
Title
Self-reported physical activity
Description
Assessed by the MESA (Multiethnic Study of Atherosclerosis) Typical Week Physical Activity Survey
Time Frame
3 months
Title
Objectively measured physical activity
Description
Assessed by a physical activity monitor (ActiGraph GT3X+)
Time Frame
3 months
Title
Systolic blood pressure
Description
Measured using standard procedures
Time Frame
3 months
Title
Serum LDL-cholesterol
Description
Measured using standard procedures
Time Frame
3 months
Title
Serum HDL-cholesterol
Description
Measured using standard procedures
Time Frame
3 months
Title
Muscle strength
Description
Assessed by the amount of weight lifted in a single chest press and leg press (1 RM).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana C Ricardo, MD
Organizational Affiliation
Assistant Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Resistance Exercise Training in Chronic Kidney Disease

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