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Title The Aerobics, Weights and Renal Disease Trial
Therapeutic Area Chronic Kidney Disease
Principal Investigator Daniel Weiner, MD
Min Age 55 Years
Gender Both
Contact Aurelia Rus
617-636-5895
More Information http://clinicaltrials.gov/ct2/show/NCT01462097

Overview

Chronic Kidney Disease (CKD) is a common condition in older adults. CKD is associated with impaired physical and cognitive function in this population. This study is a randomized clinical trial testing the effects of 12 months of aerobic and resistance exercise training versus health education on cognitive function, physical function, and health-related quality of life. The study will also examine the effects of exercise vs. health educatin on potential mediating factors including inflammation, microvascular endothelial function, and other vascular risk factors.

Interested participants have two screening visit. During the first screening visit, study personnel check kidney function, take a medical history, and administer questionnaires to make sure the participant qualifies. During the second screening visit, the participant does a stress test on a treadmill to make sure their heart responds well to exercise. If a participant qualifies for the study based on their screening visits, they proceed to two baseline visits.

Participants are randomized after their baseline visits into either the exercise or health education group. Both groups meet on the Tufts Boston campus. Participation lasts for one year. The exercise group meets three times per week for the first 6 months of participation, and two times per week for the second 6 months of participation. Each exercise session lasts for approximately 1 hour. The health education group meets once per week for the first 6 months of participation, and once per month for the second 6 months of participation. Each health education group session lasts 1 hour.

During the baseline visits, study participants complete questionnaires, have a blood draw done, do a 6minute walk, do physical functioning tests such as short balance tests and a leg press. Participants also complete a VO2 max test on a treadmill where we test the body’s ability to use oxygen during exercise. Most of the testing is repeated at 6 months and 12 months. Participants are compensated for their time with a stipend.

Study Details

Inclusion Criteria

  • Estimated glomerular filtration rate (eGFR) between 15 and 45.

Exclusion Criteria

  • Solid organ transplant
  • Current participation in a structured exercise program or currently gets more than 185 minutes per week of moderate exercise
  • Severe heart failure.

Study Requirements

Active participation in this study lasts for one year. During that time, each participant has two screening visits, two baseline visits, a 3 month safety blood draw, two 6 month visits, and two 12 month visits for a total of 9 study visits. There is also an 18 month follow-up phone call.  Blood is drawn at 5 of the visits. Study visits take a total of about 6 hours to complete. Exercise and health education sessions each take about an hour.