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Completed

NCT Number: NCT01462097

Exercise Trial in Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center / University of Maryland Medical Center, Baltimore, Maryland, United States

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About this study

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 neurocogntive 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Dementia or cognitive impairment
  • Renal transplant
  • New York 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

Treatment and study plan

Aerobic Exercise Training

Behavioral

12 months of aerobic exercise

Health Education

Behavioral

12 months of health education sessions

Primary outcomes

  1. Change in Peak Aerobic Capacity

    Time frame: Baseline, 6 months, 12 months

    VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity

  2. Change in 6 Minute Walk

    Time frame: Baseline, 6 months, 12 months

    Distance walked in 6 minutes - greater distance represents higher function

Secondary outcomes

  1. Change in Physical Function

    Time frame: Baseline, 6 months, 12 months

    Timed Up and Go Test

  2. Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)

    Time frame: Baseline, 6 months, 12 months

    Short Physical Performance Battery is a test of lower extremity function designed to be administered in older adults, consisting of three components: 1) usual gait speed over a 4-meter course; 2) five repeated chair stands; 3) standing balance battery. Each component is scored 0-4, with higher scores indicating better function, and the total scores of each component are summed (range, 0-12).

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease

Acronym: AWARD

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2011
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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