Mode of Exercise and Bone Biomarkers in Older Veterans
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy older (60+ y) Veteran women and men in the Denver Metro Area
Normally active (e.g., recreational cycling or walking exercise)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
10 Weeks of Supervised Resistance Exercise Training
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Resistance ExerciseExperimental treatment 1 intervention
Group B: Endurance ExerciseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
Time frame
Before exercise to up to 48 hours after each exercise bout2
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.
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).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.
Time frame
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.
Time frame
Change in the distance covered in the 6-minute walk test from the beginning to the end of the10 week exercise intervention.Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
Serum tCa is measured before exercise (-15, 0 minutes) and after exercise (60, 120, 300 minutes and 24 and 48 hours).Other outcomes
1
VO2peak from graded exercise test (GXT)
A cycling GXT will be performed at the beginning and the end of the exercise intervention to measure aerobic fitness. Higher values represent greater aerobic fitness.
Time frame
Change in VO2 peak from the beginning to the end of the 10 week exercise intervention.2
1-repetition maximum (1RM)
1RM of leg press will be measured at the beginning and the end of the 10 week exercise intervention to measure muscle strength. Higher weights performed during the test indicated greater muscle strength.
Time frame
Change in leg press 1RM from the beginning to the end of the 10 week exercise intervention.Sponsors and contacts
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VA Office of Research and Development
Lead sponsor
University of Colorado, Denver
Collaborator
Source ClinicalTrials.gov