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AgingMOVENCT05266976

Mode of Exercise and Bone Biomarkers in Older Veterans

A study testing 10 Weeks of Supervised Resistance Exercise Training and 10 Weeks of Supervised Endurance Exercise Training in people with Aging and Musculoskeletal Diseases, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Musculoskeletal Diseases, Osteoporosis
What is being tested?
10 Weeks of Supervised Resistance Exercise Training and 10 Weeks of Supervised Endurance Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
6 Jul 2022to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy older (60+ y) Veteran women and men in the Denver Metro Area
  • Normally active (e.g., recreational cycling or walking exercise)

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sarah J Wherry, PhD contact

(720) 848-6475

sarah.wherry@va.gov

Toby Wellington, MS contact

(720) 848-6376

toby.wellington@va.gov

United States1 site, 1 recruiting
  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

    Todd R Furbacher, PhD, 720-857-5105, todd.furbacher@va.gov

    Kimberly K Owens, MPH, (720) 857-5667, kimberly.owens9@va.gov

    Recruiting

Other trials in United States

About this study

Official title: Anabolic Versus Catabolic Skeletal Effects of Endurance or Resistance Exercise in Older Veterans

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.

Read the 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 exercise may lead to bone loss under certain conditions. It is the contention that disruptions in calcium homeostasis during exercise, resulting in a decrease in serum ionized calcium (iCa) and increases in parathyroid hormone (PTH) and c-telopeptide of type I collagen (CTX; a marker of bone resorption) that occur shortly after the start of exercise, may be responsible for the lack of the expected improvements in bone mineral density. The iCa, PTH, and CTX responses to exercise have been well-characterized for both young and older adults in response to a single endurance exercise bout, but it is unclear if resistance training (e.g., weightlifting) results in the same exercise-induced disruption in calcium homeostasis. Further, it is unclear how the iCa, PTH, and CTX response to exercise may change with exercise training, and if a bone anabolic response to exercise can be detected after repeat exercise bouts. The bone anabolic response to exercise (assessed by procollagen of type I terminal propeptide, P1NP; a marker of bone formation) has yet to be fully characterized, but that may be due to the testing of single exercise bouts and the short sampling timeline following exercise. To address these gaps in knowledge, up to 60 Veterans (30 men, 30 women), aged 60-80 years, will be randomized to 1) stationary cycling; or 2) resistance training and will complete 10 weeks of supervised exercise training 3x/week (30 total exercise training sessions). This number of exercise visits was due to the demonstrated increase in P1NP after 28 doses of teriparatide, a PTH analog, that results in bone formation. During the 1st, 15th, and 30th exercise training session, participants will undergo an acute exercise testing bout with pre- and post-exercise sampling up to 48 hours after exercise. Blood samples will be collected to measure iCa, PTH, CTX and P1NP. The primary aims are 1) to determine if resistance exercise results in a different bone biomarker response compared to what the investigators have observed during endurance exercise in older adults; 2) determine if resistance and/or endurance exercise result in an increase in P1NP over 10 weeks of exercise training. Exploratory outcomes related to changes in fitness and functional status will address how Veteran health is impacted by each exercise type, which will be used to inform future applications. The biomarker and functional outcomes information are the next step in determining the appropriate "dose" of exercise, consisting of factors such as exercise type, frequency, duration, and intensity (which will be explored in future research), can be used to enhance Veteran health. Exercise should continue to be recommended for overall health, but future interventions could incorporate what is known about the dose of exercise that is needed for cardiometabolic health and the emerging data on the dose of exercise needed to preserve bone health to create personalized exercise prescriptions to improve multiple components of Veteran health. The proposed research is significant because it is investigating several knowledge gaps that need to be addressed to design future, larger 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 novel hypotheses, the mode of exercise on the disruption in calcium homeostasis and the role of exercise training, in a population that could greatly benefit from the knowledge to be gained. Long-term, information gleaned from this research will help to define personalized exercise prescriptions to improve cardiometabolic health without compromising bone health in aging Veterans.

Being tested
10 Weeks of Supervised Resistance Exercise Training, 10 Weeks of Supervised Endurance Exercise Training
Medical subject headings
Musculoskeletal Diseases, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10 Weeks of Supervised Resistance Exercise TrainingBehavioural

    Participants will be randomized to complete 10 weeks of either resistance (weight lifting, hopping) supervised exercise. Exercise will be 3x per week for 1 hour each session. There are a total of 30 exercise sessions.

  • 10 Weeks of Supervised Endurance Exercise TrainingBehavioural

    Participants will be randomized to complete 10 weeks of endurance (stationary cycling) supervised exercise. Exercise will be 3x per week for 1 hour each session. There are a total of 30 exercise sessions.

Study groups in NCT05266976
Study groupRoleWhat they receive
Resistance ExerciseExperimentalParticipants will perform total body resistance training 3x per week for 10 weeks. Each exercise session will last approximately 1 hour.
Receives: Behavioral: 10 Weeks of Supervised Resistance Exercise Training
Endurance ExerciseExperimentalParticipants will complete 60 minutes of stationary cycling 3x per week at 70-80% of maximal heart rate for 10 weeks.
Receives: Behavioral: 10 Weeks of Supervised Endurance Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. c-telopeptide of type 1 collagen (CTX) change

    CTX is a marker of bone resorption. Reference range is 0.1-0.8 ng/mL with lower concentrations suggesting less bone resorption

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

  2. Procollagen 1 intact N-terminal propeptide (P1NP)

    PINP is a blood marker of bone formation. Reference range is 19-80 ng/mL with lower concentrations suggesting less bone formation.

    Measured: 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).

  3. Short Physical Performance Battery (SPPB)

    The Short Physical Performance Battery will be performed at the beginning and the end of the intervention to assess physical function. Scores range from 0 to 12. Higher scores generally indicate better physical function.

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

  4. 6-minute walk test

    The 6-minute walk test will be performed at the beginning and the end of the intervention to assess physical function and fitness. Greater distances covered during the 6 minute walk test generally represent greater function and fitness.

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

Secondary outcomes (3)
  1. Parathyroid Hormone (PTH)

    Parathyroid hormone is a blood marker of parathyroid function. Parathyroid hormone helps to regulate blood calcium levels. The reference range is 14 to 65 pg/mL, with levels in range suggesting normal parathyroid function.

    Measured: The change in serum PTH from before exercise to the peak following exercise following each exercise test. Peak could occur up to 48 hours following exercise.

  2. Ionized calcium (iCa)

    iCa is measured to understand the stimulus for parathyroid hormone secretion during exercise and to describe patterns of change between modes of exercise.

    Measured: Serum iCa is measured before exercise (-15, 0 minutes) and after exercise (60, 120, 300 minutes and 24 and 48 hours),

  3. Total calcium (tCa)

    tCa is measured to determine any effects of calcium binding on iCa concentration and to describe patterns of change in tCa between modes of exercise.

    Measured: Serum tCa is measured before exercise (-15, 0 minutes) and after exercise (60, 120, 300 minutes and 24 and 48 hours).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start6 Jul 2022
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Design with 2 study arms: endurance exercise and resistance exercise
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05266976
Sponsor's protocol ID
F3820-W
Other IDs
IK2RX003820
Acronym
MOVE
Status last verified
May 2026
First submitted
9 Feb 2022
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Because some journals now require authors to provide access to data, de-identified and anonymized data sets including both individual- and group-level data will be created after publication of manuscripts. The data will be made available upon request for general research purposes. To the extent possible, all care will be taken to ensure that individual-level data are at very low risk for re-identification and there will be no links to personally identifiable information.

Questions about this trial

What is this clinical trial studying?

A study testing 10 Weeks of Supervised Resistance Exercise Training and 10 Weeks of Supervised Endurance Exercise Training in people with Aging and Musculoskeletal Diseases, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah J Wherry, PhD ((720) 848-6475, sarah.wherry@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

c-telopeptide of type 1 collagen (CTX) change (time frame: Before exercise to up to 48 hours after each exercise bout). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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