Aging Clinical Trial
Official title:
COX Inhibition & Musculoskeletal Responses to Exercise
The purpose of this study is to determine if the use of ibuprofen blocks the benefits of exercise to build bone and muscle mass.
People are advised to engage in weight-bearing physical activity to help prevent the loss of
bone and muscle mass that occurs with aging. There is evidence from studies of animals that
non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, block some of the bone-
and muscle-building effects of exercise. The aim of this study is to determine whether use
of ibuprofen, either before or after exercise, blocks the benefits of exercise training on
bone and skeletal muscle in older women and men. The hypothesis is that taking ibuprofen
before exercise will block some of the effects of exercise training to increase bone density
and muscle mass.
Women and men aged 60-75 years will complete a supervised, 9-month exercise training program
designed to increase bone and muscle mass. The training will include weight lifting and
weight-bearing exercises, such as jumping in place and treadmill walking, up to 5 days per
week. Participants will be randomly assigned to take 1 of 3 study pill combinations before
and after each exercise session. The combinations of study pills will be: placebo
before/placebo after, placebo before/ibuprofen after, or ibuprofen before/placebo after. The
dose of ibuprofen will be 400 mg. Bone density of the hip and spine, body composition (total
body muscle and fat), and markers of bone turnover in the blood will be measured before and
after 4.5 and 9 months of training. Muscle cross-sectional area of the thigh will be
measured by CT before and after 9 months of training. A subset of participants will have
biopsies of the thigh muscle before and after training to measure proteins and genes
associated with muscle build-up and breakdown.
Volunteers who do not use ibuprofen, aspirin, or acetaminophen more than 3 days per month
will be enrolled. People with intolerance to ibuprofen or related drugs, cardiovascular
disease, or orthopedic problems that limit exercise will be excluded from the study.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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