Mode of Exercise and Bone Biomarkers in Older Veterans

NCT05266976 | Recruiting

• 2 other identifiers: F3820-WIK2RX003820
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

  Before exercise to up to 48 hours after each exercise bout

• 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.

  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)

  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.

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

• 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.

  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)

• Parathyroid Hormone (PTH)

  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.

• Ionized calcium (iCa)

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

• Total calcium (tCa)

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

Other Outcomes (2)

• VO2peak from graded exercise test (GXT)

  Change in VO2 peak from the beginning to the end of the 10 week exercise intervention.

• 1-repetition maximum (1RM)

  Change in leg press 1RM from the beginning to the end of the 10 week exercise intervention.

Study Arms (2)

Resistance Exercise

EXPERIMENTAL

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

Behavioral: 10 Weeks of Supervised Resistance Exercise Training

Endurance Exercise

EXPERIMENTAL

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

Behavioral: 10 Weeks of Supervised Endurance Exercise Training

Interventions

10 Weeks of Supervised Resistance Exercise Training BEHAVIORAL

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.

Resistance Exercise

10 Weeks of Supervised Endurance Exercise Training BEHAVIORAL

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.

Endurance Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sarah J Wherry, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah J Wherry, PhD

CONTACT

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

Toby Wellington, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel Design with 2 study arms: endurance exercise and resistance exercise

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 4, 2022
• Study Start: July 6, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: There is no formal plan to share these documents, although requests will be considered. Information describing the protocol and statistical analysis plan will be in place when study results are published.
• Access Criteria: Data will become available after publication of study results and will be available for at least 3 years beyond the completion of the study.

Locations

US (1)