Objective Physical Activity Assesment in Postmenopausal Women

NCT02984553 | Unknown

• 1 other identifier: ACC-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to accurately assess weekly physical activity levels of postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.

Conditions

Primary Prevention

Keywords

accelerometry; aerobic fitness; metabolic thresholds; moderate to vigorous physical activity

Outcome Measures

Primary Outcomes (1)

• Time spent in moderate-to-vigorous physical activities

  The time spent in moderate-to-vigorous physical activities during a week (The participants have to wear an accelerometer attatched at the hip on an elastic belt for a period of 7 days)

  1 week

Secondary Outcomes (3)

• accelerometer intensity cut-points

  an average of 1 month

• Number of vertical acceleration peaks during the day

  1 week

• aerobic fitness

  an average of 1 month

Other Outcomes (2)

• Maximum Strength

  1 day

• Heart rate variability

  an average of 1 month

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women

You may qualify if:

• Age between 50 and 70 years
• Surgical or natural menopause (no menstrual periods during at least the last 6 months)

You may not qualify if:

• Body mass index less than 39kg/m2 (obesity class III)
• Osteoporosis
• Presence of low-trauma fractures or severe arthrosis at hip, knees or feet
• Functional limitation to walk fast or altered gait patters and instability
• Presence of any chronic disesase that would impair the cardiovascular (e.g. myocardial infarction, stroke, chronic heart failure), musculoskeletal (osteoporosis, low-trauma fractures) and respiratory systems (COPD) or any disease or medication known to affect bone metabolism (glucocorticoids)

Sponsors & Collaborators

• Centro de Estudios, Investigación y Medicina del Deporte: lead
• University of the Basque Country (UPV/EHU): collaborator

Study Sites (1)

Centro de Estudios, Investigación y Medicina del Deporte

Pamplona, Navarre, 31005, Spain

Location

Related Publications (11)

• Vainionpaa A, Korpelainen R, Vihriala E, Rinta-Paavola A, Leppaluoto J, Jamsa T. Intensity of exercise is associated with bone density change in premenopausal women. Osteoporos Int. 2006;17(3):455-63. doi: 10.1007/s00198-005-0005-x. Epub 2006 Jan 11.

  PMID: 16404492 BACKGROUND

• Martyn-St James M, Carroll S. High-intensity resistance training and postmenopausal bone loss: a meta-analysis. Osteoporos Int. 2006;17(8):1225-40. doi: 10.1007/s00198-006-0083-4. Epub 2006 Jun 1.

  PMID: 16823548 BACKGROUND

• Borer KT, Fogleman K, Gross M, La New JM, Dengel D. Walking intensity for postmenopausal bone mineral preservation and accrual. Bone. 2007 Oct;41(4):713-21. doi: 10.1016/j.bone.2007.06.009. Epub 2007 Jun 26.

  PMID: 17686670 BACKGROUND

• Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998 May;30(5):777-81. doi: 10.1097/00005768-199805000-00021.

  PMID: 9588623 BACKGROUND

• Ozemek C, Cochran HL, Strath SJ, Byun W, Kaminsky LA. Estimating relative intensity using individualized accelerometer cutpoints: the importance of fitness level. BMC Med Res Methodol. 2013 Apr 1;13:53. doi: 10.1186/1471-2288-13-53.

  PMID: 23547769 BACKGROUND

• Sasaki JE, John D, Freedson PS. Validation and comparison of ActiGraph activity monitors. J Sci Med Sport. 2011 Sep;14(5):411-6. doi: 10.1016/j.jsams.2011.04.003. Epub 2011 May 25.

  PMID: 21616714 BACKGROUND

• Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.

  PMID: 1494764 BACKGROUND

• Miller NE, Strath SJ, Swartz AM, Cashin SE. Estimating absolute and relative physical activity intensity across age via accelerometry in adults. J Aging Phys Act. 2010 Apr;18(2):158-70. doi: 10.1123/japa.18.2.158.

  PMID: 20440028 BACKGROUND

• Lopes VP, Magalhaes P, Bragada J, Vasques C. Actigraph calibration in obese/overweight and type 2 diabetes mellitus middle-aged to old adult patients. J Phys Act Health. 2009;6 Suppl 1:S133-40. doi: 10.1123/jpah.6.s1.s133.

  PMID: 19998859 BACKGROUND

• Hannam K, Deere KC, Hartley A, Clark EM, Coulson J, Ireland A, Moss C, Edwards MH, Dennison E, Gaysin T, Cooper R, Wong A, McPhee JS, Cooper C, Kuh D, Tobias JH. A novel accelerometer-based method to describe day-to-day exposure to potentially osteogenic vertical impacts in older adults: findings from a multi-cohort study. Osteoporos Int. 2017 Mar;28(3):1001-1011. doi: 10.1007/s00198-016-3810-5. Epub 2016 Oct 31.

  PMID: 27798733 BACKGROUND

• Beneke R. Methodological aspects of maximal lactate steady state-implications for performance testing. Eur J Appl Physiol. 2003 Mar;89(1):95-9. doi: 10.1007/s00421-002-0783-1. Epub 2003 Jan 21.

  PMID: 12627312 BACKGROUND

Study Officials

• Esteban Gorostiaga, Medicine

  Centro de Estudios, Investigación y Medicina del Deporte

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 7, 2016
• Study Start: November 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)