Exercise Trial in Chronic Kidney Disease (AWARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01462097
Recruitment Status : Active, not recruiting
First Posted : October 28, 2011
Last Update Posted : January 24, 2018
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Stephen Seliger, University of Maryland

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: Aerobic exercise training Behavioral: Health Education Not Applicable

Detailed Description:

This is a parallel-group randomized controlled trial comparing 12 months of aerobic and resistance exercise training vs. health education (attention control) on neurocognitive and physical performance among community-dwelling older adults (age >55) and CKD stage 3b and 4. Co-primary outcomes are change in physical performance (including aerobic capacity and submaximal walking) and neurocogntivie performance (including executive functions).

Outcome measures will be assessed at baseline and after 6- and 12 months. Exercise training will occur thrice weekly at a dedicated research exercise center and will be supervised by exercise specialists.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease
Study Start Date : March 2012
Actual Primary Completion Date : October 31, 2017
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in neurocognitive function [ Time Frame: Baseline, 6 months, 12 months ]
    Executive function, psychomotor speed, memory, learning

  2. Change in peak aerobic capacity [ Time Frame: Baseline, 6 months, 12 months ]

  3. Change in 6 minute walk [ Time Frame: Baseline, 6 months, 12 months ]
    Distance walked in 6 minutes

Secondary Outcome Measures :
  1. Change in physical Function [ Time Frame: Baseline, 6 months, 12 months ]
    Short Physical Performance Battery, Knee extensor strength, Timed get up and go

  2. Change in endothelial function [ Time Frame: Baseline, 6 months, 12 months ]
    Microvascular function using Laser Doppler Flowmetry.

  3. Change in health-related quality of life [ Time Frame: Baseline, 6 months, 12 months ]
    Various questionnaires including the Medical Outcomes Short Form-36, Memorial Symptom Assessment Scale Short Form, and the Beck Depression Inventory

  4. Change in cardiovascular disease risk factors [ Time Frame: Baseline, 6 months, 12 months ]
    Blood pressure and various blood draw values

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01462097

United States, Maryland
Baltimore VA Medical Center / University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
University of Maryland
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Responsible Party: Stephen Seliger, Associate Professor of Medicine at University of Maryland, University of Maryland Identifier: NCT01462097     History of Changes
Other Study ID Numbers: HP-00045276
1R01DK090401-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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

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