Status:
COMPLETED
Exercise Mode and Acute Bone Resorption
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Osteoporosis
Aging
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
Endurance exercise is often recommended to improve cardiometabolic health and maintain bone health throughout life and to prevent osteoporotic fracture. However, there is evidence to suggest that bone...
Detailed Description
Endurance exercise is frequently recommended as a means to reduce the risk of cardiometabolic diseases and to reduce the risk of osteoporotic fracture. However, bone does not always adapt in the way t...
Eligibility Criteria
Inclusion
- Healthy older (60+ y) Veteran women and men will be eligible to participate
- All volunteers must be accustomed to performing 60 minutes of vigorous cycling and treadmill exercise
Exclusion
- impaired renal function, defined as an eGRF of \<60 mL/min/1.73m2;(Florkowski and Chew-Harris 2011)
- 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; 5) 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 :
October 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04815824
Start Date
October 8 2021
End Date
September 30 2024
Last Update
July 20 2025
Active Locations (1)
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1
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211