Parameters of Exercise to Prevent Osteoporosis

NCT ID: NCT04063813

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-15

Study Completion Date

2010-08-19

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Five parallel groups, matched for age and BMI, where exercise was applied at 6o uphill or 6o downhill either as one 40-min morning bout or as two 20-min half bouts distributed 7 h apart. A sedentary group served as a control for the four exercise groups.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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40 minute up trial

Subjects were subjected to 40 minutes of treadmill exercise at a 6 degree incline and at 75% of maximal effort between 8:00 and 8:40 am. Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.

Group Type EXPERIMENTAL

Experimental: 40 minute up trial

Intervention Type BEHAVIORAL

40 minute down trial

Subjects were subjected to 40 minutes of treadmill exercise at a 6 degree decline and at 45% of maximal effort between 8:00 and 8:40 am. Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.

Group Type EXPERIMENTAL

Experimental: 40 minute down trial

Intervention Type BEHAVIORAL

Two 20 minute up trials

Subjects were subjected to two 20 minutes of treadmill exercise separated by 7 h at a 6 degree incline and at 75% of maximal effort, the first one between 8:00 and 8:40 am and the second one between 15:00 and 15:20 h..Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.

Group Type EXPERIMENTAL

Experimental: Two 20 minute up trials

Intervention Type BEHAVIORAL

Two 20 min down trials

Subjects were subjected to two 20 minutes of treadmill exercise separated by 7 h at a 6 degree incline and at 45% of maximal effort , the first one between 8:00 and 8:40 am and the second one between 15:00 and 15:20 h. Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.

Group Type EXPERIMENTAL

Experimental: Two 20 min down trials

Intervention Type BEHAVIORAL

Sedentary trial

No exercise day with isocaloric meals provided at 7:00, 13:00. and 19:00 h.

Group Type ACTIVE_COMPARATOR

Active Comparator: Sedentary trial

Intervention Type BEHAVIORAL

Interventions

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Experimental: 40 minute up trial

Intervention Type BEHAVIORAL

Experimental: 40 minute down trial

Intervention Type BEHAVIORAL

Experimental: Two 20 minute up trials

Intervention Type BEHAVIORAL

Experimental: Two 20 min down trials

Intervention Type BEHAVIORAL

Active Comparator: Sedentary trial

Intervention Type BEHAVIORAL

Other Intervention Names

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40 minutes of uphill exercise divided into two 20-minute trials separated by 7 h 40 minutes of downhill exercise divided into two 20-minute trials separated by 7 h 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart A control no-exercise trial

Eligibility Criteria

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Inclusion Criteria

* Age 50 to 65 years if naturally post-menopausal, or age 47 if surgically postmenopausal
* Dual energy X-ray absorptiometry (DEXA) Z score above -1
* No endocrine or metabolic disease requiring medication except for hormonally corrected hypothyroidism
* No musculo-skeletal disabilities that would preclude treadmill walking
* Normal electrocardiogram (EKG) and heart health history
* BMI between 24 and 30
* Hematocrit above 32 %
* No hormone replacement therapy (HRT)
* Personal health provider's Release Letter

Exclusion Criteria

* Age and BMI outside of the specified range
* Z score below -1
* Medication for presence of metabolic or endocrine disease
* Musculo-skeletal disabilities that would preclude treadmill walking
* Abnormal electrocardiogram (EKG) and heart health history
* Hematocrit below 32%
* Hormone replacement therapy
* Failure to conform to study protocol
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, La Crosse

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Dr. Katarina Borer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Michigan Clinical Research Unit United States

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00007202

Identifier Type: -

Identifier Source: org_study_id

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