Exercise Trial in Chronic Kidney Disease (AWARD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University of Maryland
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Stephen Seliger, University of Maryland
ClinicalTrials.gov Identifier:
NCT01462097
First received: October 26, 2011
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated with impairment in cognition and physical function. The purpose of this study is to test the effects of 12 months of aerobic and resistance exercise training compared to health education on cognitive and physical performance in 120 older adults with CKD not requiring dialysis. The results of this study will be essential for demonstrating the effectiveness of exercise in improving function and ultimately preventing disability in this high-risk population of older adults.


Condition Intervention
Chronic Kidney Disease
Behavioral: Aerobic exercise training
Behavioral: Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Change in neurocognitive function [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Executive function, psychomotor speed, memory, learning

  • Change in peak aerobic capacity [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    VO2peak

  • Change in 6 minute walk [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Distance walked in 6 minutes


Secondary Outcome Measures:
  • Change in physical Function [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Short Physical Performance Battery, Knee extensor strength, Timed get up and go

  • Change in endothelial function [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Microvascular function using Laser Doppler Flowmetry.

  • Change in health-related quality of life [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Various questionnaires including the Medical Outcomes Short Form-36, Memorial Symptom Assessment Scale Short Form, and the Beck Depression Inventory

  • Change in cardiovascular disease risk factors [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Blood pressure and various blood draw values


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic exercise
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
Behavioral: Aerobic exercise training
12 months of aerobic exercise
Active Comparator: Health Education
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Behavioral: Health Education
12 months of health education sessions

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 3-4 Chronic kidney disease (estimated GFR 15-45)
  • Age 60 to 85
  • English Speaking

Exclusion Criteria:

  • Dementia or cognitive impairment
  • Renal transplant
  • NY Heart Association class 3-4 heart failure
  • Severe Chronic Lung Disease
  • Unstable angina or coronary revascularization within the last 3 months
  • Orthopedic problems that would preclude aerobic exercise training
  • Known, untreated infection
  • Disabling arthritis
  • Uncontrolled arrhythmia
  • More than 14 alcoholic drinks per week
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462097

Contacts
Contact: Dr. Stephen L Seliger, MD, MS 410-605-7000 ext 4840

Locations
United States, Maryland
Baltimore VA Medical Center / University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Dr. Stephen L Seliger, MD, MS    410-605-7000 ext 4840      
Principal Investigator: Dr. Stephen L Seliger, MD, MS         
Sub-Investigator: Dr. Leslie I Katzel, MD, PhD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Andrew Well    617-636-2574      
Principal Investigator: Dr. Daniel Weiner, MD         
Sponsors and Collaborators
University of Maryland
  More Information

No publications provided

Responsible Party: Stephen Seliger, Assistant Professor of Medicine at University of Maryland, University of Maryland
ClinicalTrials.gov Identifier: NCT01462097     History of Changes
Other Study ID Numbers: HP-00045276, 1R01DK090401-01A1
Study First Received: October 26, 2011
Last Updated: March 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Chronic kidney disease
Exercise
Aerobic capacity
Learning and memory
Executive function
Endothelial function

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

ClinicalTrials.gov processed this record on September 16, 2014