Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05266976

Conditions

Aging

Musculoskeletal Diseases

Osteoporosis

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

10 Weeks of Supervised Resistance Exercise Training

10 Weeks of Supervised Endurance Exercise Training

Study Details

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.

Conditions

Aging

Musculoskeletal Diseases

Osteoporosis

Study ID

NCT05266976

Start date

Jul 6, 2022

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Resistance Exercise

Participants will perform total body resistance training 3x per week for 10 weeks. Each exercise session will last approximately 1 hour.

experimental: Endurance Exercise

Participants will complete 60 minutes of stationary cycling 3x per week at 70-80% of maximal heart rate for 10 weeks.

Interventions

10 Weeks of Supervised Resistance Exercise Training

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 Training

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.

Primary outcome measure

  • c-telopeptide of type 1 collagen (CTX) change [ Time Frame: Before exercise to up to 48 hours after each exercise bout ]
  • Procollagen 1 intact N-terminal propeptide (P1NP) [ Time Frame: 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) [ Time Frame: Change in Short Physical Performance Battery score from the beginning to the end of the 10 week exercise intervention. ]
  • 6-minute walk test [ Time Frame: Change in the distance covered in the 6-minute walk test from the beginning to the end of the10 week exercise intervention. ]

Central Contacts and Locations

Central contacts

Sarah J Wherry, PhD

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

Toby Wellington, MS

(720) 848-6376toby.wellington@va.gov

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045-7211

Contacts

Todd R Furbacher, PhD

720-857-5105todd.furbacher@va.gov

Kimberly K Owens, MPH

(720) 857-5667kimberly.owens9@va.gov

Principal Investigator:

Sarah J Wherry, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-22.