RecruitingNot Applicable

Mode of Exercise and Bone Biomarkers in Older Veterans

United States120 participantsStarted 2022-07-06

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

c-telopeptide of type 1 collagen (CTX) change

Timeframe: Before exercise to up to 48 hours after each exercise bout

Procollagen 1 intact N-terminal propeptide (P1NP)

Timeframe: The primary outcome for Specific Aim 2 is the change in pre-exercise P1NP from the 1st to the 3rd exercise test (approximately 10 weeks apart).

Short Physical Performance Battery (SPPB)

Timeframe: Change in Short Physical Performance Battery score from the beginning to the end of the 10 week exercise intervention.

6-minute walk test

Timeframe: Change in the distance covered in the 6-minute walk test from the beginning to the end of the10 week exercise intervention.

Trial details

NCT IDNCT05266976

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Sarah J Wherry, PhD

(720) 848-6475 sarah.wherry@va.gov

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