Status:
RECRUITING
Mode of Exercise and Bone Biomarkers in Older Veterans
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Aging
Musculoskeletal Diseases
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
Adults are often encouraged to exercise to maintain or improve bone health. However, there is evidence that exercise does not always lead to increases in bone mass, and exercise could lead to bone los...
Detailed Description
Exercise is frequently recommended to reduce the risk of osteoporotic fracture. However, bone does not always result in the expected improvements in bone mass, and there is evidence that endurance exe...
Eligibility Criteria
Inclusion
- Healthy older (60+ y) Veteran women and men in the Denver Metro Area
- Normally active (e.g., recreational cycling or walking exercise)
Exclusion
- Impaired renal function, defined as an eGRF of \<60 mL/min/1.73m2
- Hepatobiliary disease, defined as liver function tests (AST, ALT) \>1.5 times the upper limit of normal
- Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) \<0.5 or \>5.0 mU/L
- Serum Ca \<8.5 or \>10.3 mg/dL
- Serum 25(OH)D \<20 ng/mL
- Uncontrolled hypertension, defined as resting systolic blood pressure (BP) \>150 mmHg or diastolic BP \>90 mmHg;
- History of type 1 or type 2 diabetes
- Cardiovascular disease, defined as subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT). Volunteers who have a positive GXT can be re-considered after follow-up evaluation, which must include diagnostic testing (e.g., stress echocardiogram or thallium stress test) with interpretation by a cardiologist
- Anemia, defined as a serum hemoglobin \<12.1 g/dL for women and \<14.3 g/dL for men
- Fracture in the past 6 months
- Current diagnosis or symptoms of COVID-19
- In the event of abnormal BP, live function, TSH, 25(OH)D, or hemoglobin values, volunteers can be reassessed, including after appropriate follow-up evaluation and treatment by a primary care provider. Those who have experienced symptoms of COVID-19 or have been formally diagnosed will be allowed to participate once symptoms have resolved and they are approved to return to exercise by their primary care provider.
Key Trial Info
Start Date :
July 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05266976
Start Date
July 6 2022
End Date
March 31 2027
Last Update
June 5 2025
Active Locations (1)
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1
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211