NCT05266976 Mode of Exercise and Bone Biomarkers in Older Veterans
| NCT ID | NCT05266976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-07-06 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-07-06 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 loss under certain conditions. Endurance exercise can increase bone resorption following an exercise bout, which may explain why bone does not always favorably adapt to exercise, but it is unclear if this also happens with resistance exercise. Further, it is not known how exercise training influences blood markers of bone resorption for either endurance or resistance exercise. The purpose of this study is to determine 1) if resistance exercise causes a similar increase in bone resorption as endurance exercise; and 2) if exercise training influences the increase in bone resorption following exercise for both endurance and resistance exercise.
Eligibility Criteria
Inclusion Criteria: * Healthy older (60+ y) Veteran women and men in the Denver Metro Area * Normally active (e.g., recreational cycling or walking exercise) Exclusion Criteria: * 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.
Contact & Investigator
Sarah J Wherry, PhD
PRINCIPAL INVESTIGATOR
Rocky Mountain Regional VA Medical Center, Aurora, CO
Frequently Asked Questions
Who can join the NCT05266976 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05266976 currently recruiting?
Yes, NCT05266976 is actively recruiting participants. Contact the research team at sarah.wherry@va.gov for enrollment information.
Where is the NCT05266976 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05266976 clinical trial?
NCT05266976 is sponsored by VA Office of Research and Development. The principal investigator is Sarah J Wherry, PhD at Rocky Mountain Regional VA Medical Center, Aurora, CO. The trial plans to enroll 120 participants.