Exercise Mode and Acute Bone Resorption

NCT04815824 | Completed Results

• 2 other identifiers: F3593-P1I21RX003593
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis; Aging

Keywords

exercise; bone resorption; calcium

Outcome Measures

Primary Outcomes (1)

• 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.

  Before to up to 48 hours after acute exercise bout

Secondary Outcomes (1)

• Procollagen of Type I N-terminal Propeptide (P1NP) Change

  Before to up to 48 hours after acute exercise bout

Study Arms (2)

Stationary Cycling

EXPERIMENTAL

All participants will complete one, 60-minute bout of stationary cycling

Behavioral: Exercise Mode

Treadmill Walking

EXPERIMENTAL

All participants will complete one, 60-minute bout of treadmill walking

Behavioral: Exercise Mode

Interventions

Exercise Mode BEHAVIORAL

Stationary cycling or treadmill walking

Stationary Cycling; Treadmill Walking

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 will be eligible to participate
• All volunteers must be accustomed to performing 60 minutes of vigorous cycling and treadmill exercise

You may not qualify if:

• impaired renal function, defined as an eGRF of \<60 mL/min/1.73m2;(Florkowski and Chew-Harris 2011)
• 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; 5) 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

Location

MeSH Terms

Conditions

Osteoporosis; Motor Activity; Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Results Point of Contact

• Title: Dr. Sarah Wherry
• Organization: VA Eastern Colorado Health Care System

sarah.wherry@va.gov

303-704-8054

Study Officials

• Sarah J Wherry, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Crossover design comparing mode of endurance exercise (cycling versus treadmill).

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: October 8, 2021
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 20, 2025
• Results First Posted: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)