Clinical trial NCT02984553: Objective Physical Activity Assesment in Postmenopausal Women
Official title: The Use of Lactate Thresholds to Individualize Accelerometer Cut-points and Objectively Assess Physical Activity Levels in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Prevention
Keywords: accelerometry
aerobic fitness
metabolic thresholds
moderate to vigorous physical activity
Lead sponsor: Centro de Estudios, Investigación y Medicina del Deporte
Sponsor class: OTHER_GOV
Collaborators: name: University of the Basque Country (UPV/EHU)
First posted: 2016-12-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time spent in moderate-to-vigorous physical activities
timeFrame: 1 week
Secondary outcomes:
measure: accelerometer intensity cut-points
timeFrame: an average of 1 month
measure: Number of vertical acceleration peaks during the day
timeFrame: 1 week
measure: aerobic fitness
timeFrame: an average of 1 month
Other outcomes:
measure: Maximum Strength
timeFrame: 1 day
measure: Heart rate variability
timeFrame: an average of 1 month
Locations:
city: Pamplona
country: Spain
facility: Centro de Estudios, Investigación y Medicina del Deporte
state: Navarra
Study officials:
affiliation: Centro de Estudios, Investigación y Medicina del Deporte
name: Esteban Gorostiaga, Medicine
role: STUDY_DIRECTOR
References:
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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. doi: 10.1007/s00198-006-0083-4. Epub 2006 Jun 1.
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. doi: 10.1016/j.bone.2007.06.009. Epub 2007 Jun 26.
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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. 2017 Mar;28(3):1001-1011. doi: 10.1007/s00198-016-3810-5. Epub 2016 Oct 31.
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