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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03120416
Other study ID # 2016-0421
Secondary ID K23DK094829
Status Completed
Phase N/A
First received
Last updated
Start date January 25, 2017
Est. completion date July 31, 2018

Study information

Verified date April 2019
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States University of Illinois at Chicago Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
University of Illinois at Chicago National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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