Clinical trial NCT00462722
Conditions: Aging Physical Fitness
Keywords: body composition bone density cyclooxygenase inhibitor bone metabolism muscle function muscle strength
Sponsor: University of Colorado, Denver
Start date: 2007-07-01; Completion date: 2011-12-01
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the use of ibuprofen blocks the benefits of exercise to build bone and muscle mass.

Detailed description:
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.

Arms: arm 1: placebo before and after musculoskeletal-loading exercise arm 2: placebo before and ibuprofen after musculoskeletal-loading exercise arm 3: ibuprofen before and placebo after musculoskeletal-loading exercise
Interventions: intervention 1: Ibuprofen intervention 2: Placebo intervention 3: musculoskeletal-loading exercise
Intervention descriptions: intervention 1: 400 mg with each exercise session (up to 5 days per week) for 9 months intervention 2: with each exercise session (up to 5 days per week) for 9 months intervention 3: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months

Protocol documents: