Objective Physical Activity Assesment in Postmenopausal Women

Primary Prevention Clinical Trial

Official title:

The Use of Lactate Thresholds to Individualize Accelerometer Cut-points and Objectively Assess Physical Activity Levels in Postmenopausal Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02984553
• Other study ID #: ACC-01
• Status: Active, not recruiting
• Phase: N/A
• First received: November 24, 2016
• Last updated: December 2, 2016
• Start date: November 2015
• Est. completion date: July 2017

Study information

• Verified date: December 2016
• Source: Centro de Estudios, Investigación y Medicina del Deporte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

Description:

This observational study aims to accurately assess weekly physical activity levels of postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.

Postmenopausal women will be recruited from local advertisements in public health centers. Each woman will perfom on different days a progressive discontinuous submaximal walking-running test and several constant speed tests wearing an accelerometer to identify the individual lactate threshold (LT), the maximal lactate steady state (MLSS) and the corresponding accelerometer activity counts/min (cpm). Participants then will wear an actigraph accelerometer (wGT3X-BT) for seven days.

Linear regression equations will be developed for each participant to determine accelerometer activity counts for each intensity level: 1) sedentary behaviour (<200 cpm), 2) light intensity (200 cpm to activity counts at LT), 3) moderate intensity (activity counts between LT and MLSS) and 4) vigorous intensity (activity counts >MLSS). Physical activity levels will be measured using both, individualized approach and Sasaki, Jonh and Freedson´s (2011) absolute cut-points obtained through walking and running activities eliciting 3-6 MET intensities (2689-6166 cpm), considering it a "moderate" effort.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 50 and 70 years

• Surgical or natural menopause (no menstrual periods during at least the last 6 months)

Exclusion Criteria:

• 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)

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Primary Prevention

Locations

Country	Name	City	State
Spain	Centro de Estudios, Investigación y Medicina del Deporte	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Centro de Estudios, Investigación y Medicina del Deporte	Basque Country University

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Beneke R. Methodological aspects of maximal lactate steady state-implications for performance testing. Eur J Appl Physiol. 2003 Mar;89(1):95-9. — View Citation

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. — View Citation

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. — View Citation

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. 2016 Oct 31. [Epub ahead of print] — View Citation

Lopes VP, Magalhães 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. — View Citation

Martyn-St James M, Carroll S. High-intensity resistance training and postmenopausal bone loss: a meta-analysis. Osteoporos Int. 2006;17(8):1225-40. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Vainionpää A, Korpelainen R, Vihriälä E, Rinta-Paavola A, Leppäluoto J, Jämsä T. Intensity of exercise is associated with bone density change in premenopausal women. Osteoporos Int. 2006;17(3):455-63. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum Strength	hand grip, leg and bench press maximum lifted weight (kg)	1 day	No
Other	Heart rate variability	the heart rate variability response during the walking-running tests and during the weekly physical activity assessment	an average of 1 month	No
Primary	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	No
Secondary	accelerometer intensity cut-points	accelerometer activity counts corresponding to each woman´s lactate thresholds will determine each intensity level (These thresholds are determined on the walking-running tests performed on different days with a minimum of one week in between. These tests are independent, they are performed at constant speed during 20min to determine the highest speed at which the lactate concentration remains in a steady state between the minute 10 and 20 of the test)	an average of 1 month	No
Secondary	Number of vertical acceleration peaks during the day	raw acceleration data will be measured to describe daily exposure to potentially osteogenic vertical impacts (The participants have to wear an accelerometer attatched at the hip on an elastic belt for a period of 7 days)	1 week	No
Secondary	aerobic fitness	determination of the speeds corresponding to the lactate thresolds during the walking-running test	an average of 1 month	No