Chronic Kidney DiseaseNCT03120416
Resistance Exercise Training in Chronic Kidney Disease
A study testing Resistance exercise training in people with Chronic Kidney Disease, run by University of Illinois Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Resistance exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD stage 3 or 4 (eGFR 15-60 ml/min/1.73m2)
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Resistance exercise training
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise training program | Experimental | 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. Receives: Behavioral: Resistance exercise training |
| Control | No intervention | Participants randomized to the control group will be offered an educational brochure regarding exercise published by the NKF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Measured by brachial artery flow-mediated dilation (FMD)
Measured: 3 months
Secondary outcomes (8)
Vascular function
Measured by pulse wave velocity
Measured: 3 months
Carotid artery stiffness
Measured by non-invasive ultrasound
Measured: 3 months
Self-reported physical activity
Assessed by the MESA (Multiethnic Study of Atherosclerosis) Typical Week Physical Activity Survey
Measured: 3 months
Objectively measured physical activity
Assessed by a physical activity monitor (ActiGraph GT3X+)
Measured: 3 months
Systolic blood pressure
Measured using standard procedures
Measured: 3 months
Serum LDL-cholesterol
Measured using standard procedures
Measured: 3 months
Serum HDL-cholesterol
Measured using standard procedures
Measured: 3 months
Muscle strength
Assessed by the amount of weight lifted in a single chest press and leg press (1 RM).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start25 Jan 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Ana C. Ricardo, MD, MPH, MS, University of Illinois Chicago
- Investigators
- Ana C Ricardo, MD, Principal investigator, Assistant Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120416
- Sponsor's protocol ID
- 2016-0421
- Other IDs
- K23DK094829
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Exercise Training on Endothelial Function and Cardiovascular Risk Factors in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03120416
- Acronym / sponsor ID
- 2016-0421
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise training program | Experimental | Behavioral: Resistance exercise trainingEight 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. |
| Control | No intervention | –Participants randomized to the control group will be offered an educational brochure regarding exercise published by the NKF. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CKD stage 3 or 4 (eGFR 15-60 ml/min/1.73m2)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercise training12-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. | Behavioural | Resistance exercise training program |
Primary outcome
Endothelial function
Time frame: 3 months
Measured by brachial artery flow-mediated dilation (FMD)
8 secondary outcomes
Vascular function
Time frame: 3 months
Carotid artery stiffness
Time frame: 3 months
Self-reported physical activity
Time frame: 3 months
Objectively measured physical activity
Time frame: 3 months
Systolic blood pressure
Time frame: 3 months
Serum LDL-cholesterol
Time frame: 3 months
Serum HDL-cholesterol
Time frame: 3 months
Muscle strength
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana C Ricardo, MD principal investigator
Assistant Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise training in people with Chronic Kidney Disease, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.