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Trial record 29 of 29 for:    Pulmonary Hypertension OR Vascular dementia OR Vascular Dementia OR Vascular Contributions to Cognitive Impairment and Dementia | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Exercise Training and Cognitive Function in Kidney Disease

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ClinicalTrials.gov Identifier: NCT03197038
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
Midwest Roybal Center for Health Promotion and Translation
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Ulf G. Bronas, University of Illinois at Chicago

Brief Summary:
Chronic kidney disease (CKD), affects over 45% of all individuals over 70 years of age. Patients with moderate CKD have more than a two-fold increased risk of cognitive impairment than those without CKD; furthermore, as many as 20-70% of patients with CKD have established cognitive impairment and overt dementia. The burden of cognitive impairment and dementia leads to functional decline and accelerated loss of independence, contributing to the tremendous individual, societal, and economic burden of CKD (i.e., 20% of Medicare expenditures in adults >65 years of age). There is no recommended treatment to prevent cognitive decline in CKD patients, and the few medications available for cognitive impairment have only short term modest effects. There is a critical need to evaluate therapies to forestall cognitive impairment, and maintain or improve cognitive functioning in older patients with CKD. To address this need, this study will test the hypothesis that older patients with moderate/severe CKD and pre-clinical cognitive impairment randomized to a 6-month home-based exercise program will improve cognitive function and MRI measured brain structure, compared to a usual care control group. This study will combine an assessment of cognition with MR imaging techniques to fully evaluate brain structure, blood flow, and behavior relationships at a level previously not conducted in this population

Condition or disease Intervention/treatment Phase
Cognitive Function, Preclinical Chronic Kidney Diseases Older Adults Behavioral: Partially supervised home-based walking exercise Behavioral: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled design with a 1:1 allocation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Training and Cognitive Function in Kidney Disease
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home-based walking exercise
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Behavioral: Partially supervised home-based walking exercise
Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.

Active Comparator: Control
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Behavioral: Control
Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.




Primary Outcome Measures :
  1. Composite Global Cognitive function [ Time Frame: Change from baseline in composite global cognitive function at 6 months ]
    Determine the effect of a 6-month home-based exercise program on composite global cognitive functioning as determined by principal component analysis of immediate free recall of trials 1-5 on California verbal learning II, long-delay free recall and recognition, and memory discriminability, trail making test part A and part B, digit symbol substitution test, semantic and phonemic fluency, and Digit span subtest in older patients with kidney disease and preclinical cognitive impairment.

  2. Composite Executive Function [ Time Frame: Change from baseline in composite executive function at 6 months ]
    Determine the effect of a 6-month home-based exercise program on composite executive functioning as determined by principal component analysis of semantic and phonetic fluency, trail making test part B, and digit span subtest in older patients with kidney disease and preclinical cognitive impairment.


Secondary Outcome Measures :
  1. White Matter Integrity [ Time Frame: Change from baseline white matter integrity at 6 months ]
    Determine the effect of a 6-month exercise program on white matter integrity.

  2. Hippocampal volume [ Time Frame: Change from baseline hippocampal volume at 6 months. ]
    Determine the effect of a 6-month exercise program on hippocampal volume

  3. Cerebral blood flow [ Time Frame: Change from baseline in cerebral blood flow at 6 months. ]
    Determine the effect of a 6-month exercise program on cerebral blood flow..

  4. vascular health [ Time Frame: Change from baseline in vascular health indicies at 6 months ]
    Determine the effect of a 6-month exercise program on vascular health indicies.

  5. Cognitive function [ Time Frame: Change from baseline in NIH toolbox cognitive function indicies at 6 months ]
    Determine the effect of a 6-month exercise program on cognitive function via the NIH toolbox

  6. Motor Function [ Time Frame: Change from baseline in NIH toolbox motor function indicies at 6 months ]
    Determine the effect of a 6-month exercise program on motor function via the NIH toolbox

  7. Multimodal Connective networks [ Time Frame: Change from baseline in resting connective network indicies at 6 months ]
    Determine the effect of a 6-month exercise program on resting mulitmodal connective networks



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English speaking men and women
  • diagnosed stage 3-5 CKD (eGFR<60 to 15 ml/min);
  • 60-80 years of age,
  • self-experienced persistent decline in cognitive capacity determined as self-reported cognitive complaint (i.e., answering "yes" to the question: "Do you feel like your memory or thinking skills have gotten worse recently?" (before any clinical impairment of cognition has occurred)
  • ability to undergo an MRI;
  • no history of major head trauma.

Exclusion Criteria:

  • • current/past diagnosis of neurological/psychiatric disorders;

    • any medications to improve cognition or mood;
    • Diagnosed Dementia or a score of <2 on the mini-cog assessment
    • Ischemic ulcerations or gangrene on the feet or legs;
    • Participating in a supervised exercise program with intent to increase fitness levels 3 days/week,
    • Requires assistive ambulation;
    • Limited exercise capacity due to conditions other than claudication

      • unstable angina,
      • Claudication
      • severe arthritis,
      • extreme dyspnea on exertion,
      • unstable coronary artery disease;
      • Class III-IV heart failure;
      • Current uncontrolled sustained arrhythmias,
      • severe/symptomatic aortic or mitral stenosis,
      • hypertrophic obstructive cardiomyopathy,
      • severe pulmonary hypertension,
      • active myocarditis/pericarditis,
      • thrombophlebitis,
      • recent systemic/pulmonary embolus (within 3 months);
    • Resting systolic BP >200 mmHg or resting diastolic BP >110 mmHg;
    • Revascularization procedures within the previous 6 months;
    • Any unforeseen illness or disability that would preclude exercise testing or training based on patient provider opinion;
    • Pregnancy
    • No diagnosis of CKD
    • One or more contraindication for MRI

      • cardiac pacemaker,
      • aneurysm clip,
      • cochlear implants,
      • shrapnel,
      • history of metal fragments in eyes,
      • neurostimulators,
      • diagnosed claustrophobia.

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): NCT03197038


Contacts
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Contact: Ulf G Bronas, PhD 312-355-5886 bronas@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Ulf G Bronas, PhD    312-355-5886    bronas@uic.edu   
Principal Investigator: Ulf G Bronas, PhD         
Sponsors and Collaborators
University of Illinois at Chicago
Midwest Roybal Center for Health Promotion and Translation
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Ulf G Bronas, PhD University of Illinois at Chicago

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Responsible Party: Ulf G. Bronas, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03197038     History of Changes
Other Study ID Numbers: 2016-1217
P30AG022849 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ulf G. Bronas, University of Illinois at Chicago:
Cognitive function
Kidney Disease
Exercise
Older adults
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency