Myogenic and Osteogenic Responses to eXercise and Ibuprofen
Condition: Aging; Physical Fitness
Study type: Interventional

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.
    

Intervention name(s): Ibuprofen; Placebo; musculoskeletal-loading exercise
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 400 mg with each exercise session (up to 5 days per week) for 9 months; with each exercise session (up to 5 days per week) for 9 months; 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
Other intervention name(s): Motrin; Advil
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: body composition; bone density; cyclooxygenase inhibitor; bone metabolism; muscle function; muscle strength