An interventional study of Exercise Mode in Osteoporosis and Aging, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Prevention
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 does not always adapt in the way that is expected, and that endurance exercise may lead to bone loss under certain conditions. Disruptions in calcium homeostasis during exercise may explain this observation, and preliminary data suggests that the mode of exercise (i.e., cycling versus treadmill) may result in different magnitudes of change in bone biomarkers. The purpose of this study is to determine if mode of exercise results in a differential bone biomarker response to an acute exercise bout in older Veterans. Blood samples will be collected before, during, and after 2 acute exercise bouts: 1) brisk treadmill walking; and 2) vigorous stationary cycling. Bouts will be matched for relative intensity and duration. This data will be used to develop future exercise interventions in older Veterans aimed at preserving both cardiometabolic and bone health.
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 that would be expected, and there is evidence that endurance exercise may lead to bone loss under certain conditions. It is the investigators contention that disruptions in calcium homeostasis during exercise, resulting in decreases in serum ionized calcium (iCa) and increases in parathyroid hormone (PTH) and c-telopeptide of type I collagen (CTX; a marker of bone resorption) at the onset of exercise, may be responsible for the lack of improvements in bone mineral density that are anticipated. Acute studies in this area have predominantly focused on young, healthy adults, primarily men, during stationary cycling exercise. Few studies have been conducted in older adults, but those studies have found that older adults experience similar disruptions in calcium homeostasis in response to an acute bout of endurance exercise. Preliminary comparisons of the investigators studies, as well as research from other labs, also suggests that that mode of exercise conducted during these acute exercise bouts may be an important determining factor in the catabolic bone response to exercise. It appears that weight-bearing exercise (i.e., treadmill) results in smaller increases in PTH and CTX compared to weight-supported exercise (i.e., stationary cycling). This has never been tested using a within-subjects design, so it is unclear if these observed differences are due to the mode of exercise, lab-to-lab differences, or other underlying factors. To address this gap in knowledge, 30 Veterans (15 men, 15 women), aged 60+ years, will complete two 1-hour acute exercise bouts: 1) brisk treadmill walking at 70-80% of maximal heart rate; 2) vigorous stationary cycling at 70-80% maximal heart rate. Blood samples will be collected to measure iCa, PTH, CTX and procollagen type I n-terminal propeptide (P1NP) before, during, and after each exercise bout. The order of the exercise bouts will be randomized and counter-balanced. The primary aim is to determine if mode of exercise results in a differential bone biomarker response in older Veterans. This information is essential for understanding how future exercise interventions should be designed to benefit both cardiometabolic health and bone health. This is especially relevant to Veteran health due to the high burden of both cardiometabolic diseases (e.g., diabetes, heart disease) in the population, as well as evidence of increased osteoporotic fracture risk. The proposed research is significant because it is addressing a knowledge gap that has prevented the ability to design exercise and lifestyle interventions aimed at preserving multiple components of Veteran health, which could have a lasting impact on Veteran quality of life and functional independence. The proposed research is innovative because it is testing a novel hypothesis, the mode of exercise on disruptions in calcium homeostasis, in a population that could greatly benefit from the knowledge to be gained. While the proposed research is an acute study, the results generated will be used to design future clinical interventions for Veteran health. Long-term, information gained from this research will help to define the optimal exercise prescription to improve cardiometabolic without compromising bone health aging Veterans.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's enrollment of 9 is below the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
current diagnosis or symptoms of COVID-19
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will complete one, 60-minute bout of stationary cycling
Behavioral: Exercise Mode
All participants will complete one, 60-minute bout of treadmill walking
Behavioral: Exercise Mode
Stationary cycling or treadmill walking
C-telopeptide of Type I Collagen (CTX) Change
CTX is a blood marker of bone resorption. Reference range is 0.1-0.8 ng/mL with lower concentrations suggesting less bone resorption.
Time frame: Before to up to 48 hours after acute exercise bout
Procollagen of Type I N-terminal Propeptide (P1NP) Change
PINP is a blood marker of bone formation. Reference range is 19-80 ng/mL with lower concentrations suggesting less bone formation.
Time frame: Before to up to 48 hours after acute exercise bout
| Milestone | Stationary Cycling First, Then Treadmill Walking | Treadmill Walking First, Then Stationary Cycling |
|---|---|---|
| Started | 5 | 4 |
| Completed | 5 | 4 |
| Not completed | 0 | 0 |
| Milestone | Stationary Cycling First, Then Treadmill Walking | Treadmill Walking First, Then Stationary Cycling |
|---|---|---|
| Started | 5 | 4 |
| Completed | 5 | 4 |
| Not completed | 0 | 0 |
| Milestone | Stationary Cycling First, Then Treadmill Walking | Treadmill Walking First, Then Stationary Cycling |
|---|---|---|
| Started | 5 | 4 |
| Completed | 5 | 4 |
| Not completed | 0 | 0 |
CTX is a blood marker of bone resorption. Reference range is 0.1-0.8 ng/mL with lower concentrations suggesting less bone resorption.
| ng/mL | Stationary Cycling | Treadmill Walking |
|---|---|---|
| C-telopeptide of Type I Collagen (CTX) Change | 0.09 ± 0.06 | 0.08 ± 0.07 |
PINP is a blood marker of bone formation. Reference range is 19-80 ng/mL with lower concentrations suggesting less bone formation.
| ng/mL | Stationary Cycling | Treadmill Walking |
|---|---|---|
| Procollagen of Type I N-terminal Propeptide (P1NP) Change | -3.1 ± 7.8 | -1.5 ± 7.1 |
Collected over Adverse event information was collection from time of informed consent to completion of the study, which was approximately 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stationary Cycling | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Treadmill Walking | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
Because all participants completed both interventions (60 minutes of stationary cycling, 60 minutes of treadmill walking), participant characteristics have been collapsed into one Arm/Group titled "All Study Participants."
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 9 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 72 ± 2 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 1 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Study Participants |
|---|---|
| United States | 5 |
| Cardiorespiratory Fitness (VO2peak)(mL/kg/min) | All Study Participants |
|---|---|
| Mean | 25.8 ± 3.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2021 to primary completion in Jun 2024, 32 months.
Results were first posted in Jul 2025, 1 year after primary completion.
Of 219 non-industry interventional studies with no phase under Osteoporosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 49. This study's 32 months is above that.
Counting every sponsor, half of 238 studies reached it within 26 months; a quarter within 9 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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