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Primary PreventionNCT02984553

Objective Physical Activity Assesment in Postmenopausal Women

An observational study of Primary Prevention, run by Centro de Estudios, Investigación y Medicina del Deporte at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Primary Prevention
How many people
80 participants
Where
1 siteSpain
Study dates
Nov 2015to Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Postmenopausal women

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Centro de Estudios, Investigación y Medicina del Deporte

    Pamplona, Navarre, 31005

Other trials in Spain

About this study

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

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.

Read the 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.

Keywords
accelerometry, aerobic fitness, metabolic thresholds, moderate to vigorous physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 1 week

Secondary outcomes (3)

  1. 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)

    Measured: an average of 1 month

  2. 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)

    Measured: 1 week

  3. aerobic fitness

    determination of the speeds corresponding to the lactate thresolds during the walking-running test

    Measured: an average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionJul 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02984553
Sponsor's protocol ID
ACC-01
Status last verified
Dec 2016
First submitted
24 Nov 2016
Last updated
7 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Codified IPD (personal data not shown, e.g. 321RR) will be shared with the Musculoskeletal Research Unit of the University of Bristol for the deep analysis of the 3th outcome

Publications

  • 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.

    PubMed 16404492

  • 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.

    PubMed 16823548

  • 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.

    PubMed 17686670

  • 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.

    PubMed 9588623

  • 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.

    PubMed 23547769

  • 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.

    PubMed 21616714

  • 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.

    PubMed 1494764

  • 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.

    PubMed 20440028

  • 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.

    PubMed 19998859

  • 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.

    PubMed 27798733

  • 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.

    PubMed 12627312

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Prevention, run by Centro de Estudios, Investigación y Medicina del Deporte at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time spent in moderate-to-vigorous physical activities (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02984553, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.

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