Michigan Clinical Research Unit United States
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT04063813
The principal goal of this study is to determine parameters of walking in terms of peak mechanical vertical force, bout duration, and bout spacing that can preserve or increase bone mineral density (BMD) in postmenopausal women. Release of pulses of parathyroid hormone (PTH), growth hormone (GH), and of markers of bone resorption and bone formation will be used as indicators of the osteogenic effects of a short exposure to exercise. When secreted in pulsatile fashion, GH stimulates osteoblast proliferation, particularly in cortical bone (27, 28). Like GH, the pattern of PTH secretion determines the nature of its effect on bone. When it is secreted in pulsatile manner, PTH contributes to bone formation through activation of bone lining cells, differentiation of osteoprogenitor cells, and suppression of bone cell apoptosis .
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Notify Me50 year–65 year
Female
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
A. Hypotheses and specific aims:
Specific aim 1. Measure plasma concentrations of anabolic hormones (parathyroid hormone (PTH) and growth hormone (GH), at sufficient frequency to define the area under the curve (AUC), and of markers of bone formation (osteocalcin, carboxyterminal propeptide of type 1 procollagen (CICP), and bone-specific alkaline phosphatase (ALKP)), and markers of bone resorption (immunoreactive carboxyterminal telopeptide of type I collagen (CTX)) after 40-minutes of treadmill exercise at the relative intensity of 125% of the ventilatory threshold (VT) corresponding to about 1.78 m/sec (4 miles/h), and two intensities of mechanical loading (724, and 1411 N), in healthy postmenopausal women.
Hypothesis 1. Bone formation, as assessed by increases in markers of bone formation and decreases in markers of bone resorption, will be higher in response to dynamic exercise at a level of mechanical loading that produces increased secretion of PTH and GH than to exercise at other loading intensities.
Specific aim 2. Measure plasma concentrations of anabolic hormones), at sufficient frequency to define the area under the curve (AUC), and of markers of bone formation as in specific aim 1, after two 20-minutes of treadmill exercise, separated by 7 h, at the relative intensity of 125% of the ventilatory threshold (VT) corresponding to about 1.78 m/sec (4 mi/h), and two intensities of mechanical loading (724, and 1411 N), in healthy postmenopausal women.
Hypothesis 2. A 7-hour interval separating the two bouts of exercise will have greater bone anabolic effect than the equivalent volume and intensity of exercise performed in a single bout.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: 40 minutes of uphill exercise divided into two 20-minute trials separated by 7 h
Other names: 40 minutes of downhill exercise divided into two 20-minute trials separated by 7 h
Other names: 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart
Other names: 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart
Other names: A control no-exercise trial
Time frame: During last 5 minutes of treadmill walking
Sum of pressures on mechanosensitive Novel-Pedar shoe insoles
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Concentration of osteocalcin measured in serum samples
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Concentration of CICP measured in serum samples
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Concentration of CTX measured in serum samples
Time frame: 1 day (measured throughout treadmill exercise bouts)
Percent of maximal aerobic capacity used during uphill and downhill exercise
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Concentration of insulin measured in serum samples
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Concentration of cortisol measured in serum samples
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Concentration of GH measured in serum samples
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Concentration of PTH measured in serum samples
University of Michigan
Other
Acronym: OSTEOPOROSISEX
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