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Trial record 85 of 7858 for:    "Kidney Diseases"

Mechanisms of Muscle Blood Flow Dysregulation and Exercise Intolerance in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02664519
Recruitment Status : Recruiting
First Posted : January 27, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Wanpen Vongpatanasin, University of Texas Southwestern Medical Center

Brief Summary:
Patients with chronic kidney disease (CKD) experience fatigue and exercise intolerance. Increased oxidative stress in CKD may be a contributing factor. The role of impaired muscle blood flow regulation has not been fully explored. The investigators hypothesize that functional sympatholysis is exaggerated in CKD and this is associated with increased oxidative stress. The investigators also hypothesize that exercise training will improve functional sympatholysis and oxidative stress

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: Forearm exercise training Not Applicable

Detailed Description:

Progressive muscle weakness and premature fatigue are characterize the condition of chronic kidney disease (CKD) which can be very debilitating. Mechanisms underlying exercise intolerance in CKD is not completely understood. Previous studies have demonstrated impaired skeletal muscle vasodilation during exercise in CKD patients, which may contribute to exercise intolerance. Normally, there is blunting of sympathetic mediated vasoconstriction in exercising muscle to allow for steady blood supply to exercising muscles. This phenomenon is called functional sympatholysis. Functional sympatholysis is impaired by increases in reactive oxygen specie and may be impaired in CKD.

Experiments will be performed on 2 groups of subjects 1) Normal kidney function (eGFR>90) 2) Stage 2-3 CKD (eGFR 30-89). VAsoactive medications will be held for 72 hours before study. All participants will attend a baseline study visit, which will include a physical examination, a medical history review, vital sign measurements, and blood collection. Muscle nerve activity and muscle oxygenation will be measured while the subjects perform hand grip exercise at 30% maximum voluntary contraction with and without lower body negative pressure (- 20 mmHg). Muscle blood flow will be measured before and after hand grip exercises. CKD subjects will then be randomized to exercise training (to squeeze a tennis ball repeatedly for at least 30 min/day) or no exercise training for 28 days. Procedures in baseline visit will be repeated followed by cross over to alternate group for 28 days followed by repeat of baseline procedures. Blood flow, muscle oxygenation and muscle nerve activity will be compared between CKD and normal subjects as well as before and after exercise training for CKD subjects.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mechanisms of Muscle Blood Flow Dysregulation and Exercise Intolerance in Chronic Kidney Disease
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise training followed by no exercise training
CKD subjects will be randomized to exercise training (to squeeze a tennis ball repeatedly for at least 30 min/day) or no exercise training for 28 days. Procedures in baseline visit will be repeated followed by cross over to alternate group for 28 days followed by repeat of baseline procedures.
Behavioral: Forearm exercise training
Subjects will be asked to squeeze a tennis ball repeatedly for at least 30 min/day for 28 days at an approximate rate of 20 squeezes/min.

Experimental: No exercise training followed by exercise training
CKD subjects will be randomized to exercise training (to squeeze a tennis ball repeatedly for at least 30 min/day) or no exercise training for 28 days. Procedures in baseline visit will be repeated followed by cross over to alternate group for 28 days followed by repeat of baseline procedures.
Behavioral: Forearm exercise training
Subjects will be asked to squeeze a tennis ball repeatedly for at least 30 min/day for 28 days at an approximate rate of 20 squeezes/min.

No Intervention: Normal Control
Control subjects without CKD will undergo baseline assessment as above.



Primary Outcome Measures :
  1. Change in muscle oxygenation [ Time Frame: After 28 days ]
    Tissue oxygenation will be recorded using Near-infrared spectroscopy (NIRS)


Secondary Outcome Measures :
  1. Change in Forearm vascular conductance (FVC) [ Time Frame: After 28 days ]
    Doppler ultrasonography to measure blood flow

  2. Change in plasma isoprostanes [ Time Frame: After 28 days ]
    Plasma isoprostanes will be used as a measure of oxidative stress

  3. Change in muscle sympathetic nerve activity (MSNA) [ Time Frame: After 28 days ]
    MSNA will be measured using tiny tungsten wire inserted into the common peroneal nerve below fibular head.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normotensive adults
  • CKD 2-3

Exclusion Criteria:

  • Blood Pressure ≥140/90
  • eGFR >60ml/min/1.73 m2 or eGFR <30ml/min/1.73 m2
  • Any evidence of cardiopulmonary disease, left ventricular hypertrophy or systolic dysfunction by echocardiography.
  • Diabetes mellitus or other systemic illness
  • Pregnancy
  • Any history of substance abuse or current cigarette use
  • Any history of psychiatric illness
  • History of malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664519


Contacts
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Contact: Poghni A Peri-Okonny, MD 2146483188 poghni.peri-okonny@utsouthwestern.edu
Contact: Debbie Arbique, DNP 2146482968 debbie.arbique@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Poghni Peri-Okonny, MD    214-648-3188    poghni.peri-okonny@utsouthwestern.edu   
Principal Investigator: Wanpen Vongpatanasin, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Wanpen Vongpatanasin, MD UT Southwestern Medical Center

Publications of Results:

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Responsible Party: Wanpen Vongpatanasin, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02664519     History of Changes
Other Study ID Numbers: STU 092015-005
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Keywords provided by Wanpen Vongpatanasin, University of Texas Southwestern Medical Center:
Chronic Kidney Disease
Functional sympatholysis
Exercise training
Exercise intolerance
Handgrip exercise
Near infrared spectroscopy
Lower body negative pressure

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency