Resistance Exercise Training in Chronic Kidney Disease

NCT ID: NCT03120416

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Resistance exercise training

Intervention Type BEHAVIORAL

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Ana C. Ricardo, MD, MPH, MS

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana C Ricardo, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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K23DK094829

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-0421

Identifier Type: -

Identifier Source: org_study_id

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