NCT04063813

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2010

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

3.3 years

First QC Date

August 19, 2019

Last Update Submit

August 20, 2019

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (4)

  • Ground reaction forces

    Sum of pressures on mechanosensitive Novel-Pedar shoe insoles

    During last 5 minutes of treadmill walking

  • Serum osteocalcin

    Concentration of osteocalcin measured in serum samples

    Hourly blood draws between 8:00 and 22:00 hours

  • Serum CICP (c-terminal propeptide of type 1 collagen

    Concentration of CICP measured in serum samples

    Hourly blood draws between 8:00 and 22:00 hours

  • Serum CTX (c-terminal telopeptide of type 1 collagen

    Concentration of CTX measured in serum samples

    Hourly blood draws between 8:00 and 22:00 hours

Secondary Outcomes (5)

  • Relative aerobic capacity

    1 day (measured throughout treadmill exercise bouts)

  • Serum insulin

    Hourly blood draws between 8:00 and 22:00 hours

  • Serum cortisol

    Hourly blood draws between 8:00 and 22:00 hours

  • Serum GH (growth hormone)

    Hourly blood draws between 8:00 and 22:00 hours

  • serum PTH (parathyroid hormone)

    Hourly blood draws between 8:00 and 22:00 hours

Study Arms (5)

40 minute up trial

EXPERIMENTAL

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.

Behavioral: Experimental: 40 minute up trial

40 minute down trial

EXPERIMENTAL

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.

Behavioral: Experimental: 40 minute down trial

Two 20 minute up trials

EXPERIMENTAL

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.

Behavioral: Experimental: Two 20 minute up trials

Two 20 min down trials

EXPERIMENTAL

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.

Behavioral: Experimental: Two 20 min down trials

Sedentary trial

ACTIVE COMPARATOR

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

Behavioral: Active Comparator: Sedentary trial

Interventions

Experimental: 40 minute up trialBEHAVIORAL
Also known as: 40 minutes of uphill exercise divided into two 20-minute trials separated by 7 h
40 minute up trial
Experimental: 40 minute down trialBEHAVIORAL
Also known as: 40 minutes of downhill exercise divided into two 20-minute trials separated by 7 h
40 minute down trial
Experimental: Two 20 minute up trialsBEHAVIORAL
Also known as: 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart
Two 20 minute up trials
Experimental: Two 20 min down trialsBEHAVIORAL
Also known as: 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart
Two 20 min down trials
Active Comparator: Sedentary trialBEHAVIORAL
Also known as: A control no-exercise trial
Sedentary trial

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostmenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan Clinical Research Unit United States

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 21, 2019

Study Start

May 15, 2007

Primary Completion

August 19, 2010

Study Completion

August 19, 2010

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

US(1)