Movement and Behaviours Measurement Study

NCT ID: NCT04173715

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-14

Study Completion Date

2026-12-31

Brief Summary

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There are few studies that already have validated specific raw accelerometer cut-points for people over 65 years old.

The purpose of the present study is to validate raw accelerometer cut points for general people over 65 years old and specific raw accelerometer cut points based on the functional status of older adults over 65 years old.

The study will be carried out with an observational approach. Participants will be divided into 4 groups. First of them will be made grouping all subjects and the rest divided according to their functional status. They will perform different-intensity physical activities while wearing accelerometers attached to their body and wearing a portable gas analyser too. Their intensity will be assessed based on their own Rest Metabolic Rate (RMR). Energy expenditure and accelerations will be matched and, based on that, sedentary behaviour, light physical activity and moderate-to-vigorous physical activity cut-points will be derived.

Detailed Description

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Knowledge on health implications of sedentary time and physical activity has been substantially improved in the last decades with accelerometer-based estimations. The popularity of these devices is partially explained by the capacity of objectively recording physical behaviors (e.g., sleep, sedentary time, physical activity…) during the whole day. The so-called "cut-point" approach is behind most of the research on physical activity with accelerometers. Cut-points provide metrics that are easy to understand, to translate to the public and to replicate by researchers in different settings. Usually, the minimum requirement is to use cut-points adapted to the age-group of the population of interest.

Under this paradigm, cut-points have been developed in all age-groups and with a variate set to data collection and processing protocols. However, some scenarios lack of available cut-points to implement, being older adults (\> 65 years) the population with less alternatives of cut-points to use. In this sense, studies with older adults choose cut-points developed in younger adults to classify physical activity intensities. Biomechanical and physiological differences between adults and older adults advise against using this strategy. Therefore, relative energy expenditure and functional status should be considered for future cut-points design. Moreover, must be also awarded that hardly any previous cut-points validation protocols have been performed in a free-living setting. For this reason, more studies following these designs seems necessary to improve cut-points population's validity. Missing all mentioned factors could lead to physical activity and sedentary behavior patterns misclassification in this population.

Conditions

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Aging Physical Function Frailty Syndrome Physical Disability Lifestyle, Sedentary

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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General Group

All those who are over 65 years old and capable of walking by themselves.

Older Adults Group.

Intervention Type BEHAVIORAL

Physical activity and energy expenditure quantification

Low Physical Function Status Group.

All those who present a low physical function status will be included in this group.

Low Physical Function Status Group

Intervention Type BEHAVIORAL

Physical activity and energy expenditure quantification

Medium Physical Function Status Group

Intervention Type BEHAVIORAL

Physical activity and energy expenditure quantification

Medium Physical Function Status Group.

All those who present a medium physical function status will be included in this group.

Low Physical Function Status Group

Intervention Type BEHAVIORAL

Physical activity and energy expenditure quantification

Medium Physical Function Status Group

Intervention Type BEHAVIORAL

Physical activity and energy expenditure quantification

High Physical Function Status Group

Intervention Type BEHAVIORAL

Physical activity and energy expenditure quantification

High Physical Function Status Group.

All those who present a high physical function status will be included in this group.

High Physical Function Status Group

Intervention Type BEHAVIORAL

Physical activity and energy expenditure quantification

Interventions

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Older Adults Group.

Physical activity and energy expenditure quantification

Intervention Type BEHAVIORAL

Low Physical Function Status Group

Physical activity and energy expenditure quantification

Intervention Type BEHAVIORAL

Medium Physical Function Status Group

Physical activity and energy expenditure quantification

Intervention Type BEHAVIORAL

High Physical Function Status Group

Physical activity and energy expenditure quantification

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 65 years and older
* Non-institutionalized
* Physical function assessment (SPPB\>3)

Exclusion Criteria

* Have started an exercise program.
* Mini-Mental Score \< 18.
* Presenting any physical activity contraindication.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role lead

Responsible Party

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Ignacio Ara

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ignacio Ara Royo

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Castilla-La Mancha

Locations

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Universidad de Castilla-La Mancha, Laboratorio de Actividad Física y Función Muscular

Toledo, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ignacio Ara Royo

Role: CONTACT

+34 925268800 ext. 5543

Javier Leal Martín

Role: CONTACT

+34 925268800 ext. 96808

Facility Contacts

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Javier Leal Martín, PhD Student

Role: primary

+34925268800 ext. 96808

Other Identifiers

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CEIC-CHT-568

Identifier Type: -

Identifier Source: org_study_id

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