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Movement and Behaviours Measurement Study

Observational Aging Physical Function Frailty Syndrome Physical Disability

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Older Adults Group., Low Physical Function Status Group, Medium Physical Function Status Group, High Physical Function Status Group.
Who it may be relevant to
Registry conditions: Aging, Physical Function, Frailty Syndrome, Physical Disability. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Validation of Cut-points to Estimate Sedentary Time and Physical Activity Intensities in Older Adults

Overview

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

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.

Interventions

  • Behavioral Older Adults Group.
    Physical activity and energy expenditure quantification
  • Behavioral Low Physical Function Status Group
    Physical activity and energy expenditure quantification
  • Behavioral Medium Physical Function Status Group
    Physical activity and energy expenditure quantification
  • Behavioral High Physical Function Status Group
    Physical activity and energy expenditure quantification

Primary outcome measures

  • Rest Metabolic Rate [Time frame: Through study completion, an average of 1 year]
  • Energy expenditure during physical activity performance [Time frame: Through study completion, an average of 1 year]
  • Accelerometry [Time frame: Through study completion, an average of 1 year]
  • Physical function [Time frame: Through study completion, an average of 1 year]
  • Frailty Status [Time frame: Through study completion, an average of 1 year]
  • Physical Activity and Sedentary Behaviour Patterns. [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (2)
  • Heart Rate [Time frame: Through study completion, an average of 1 year]
  • Body composition [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Spain · 1 center
  • Universidad de Castilla-La Mancha, Laboratorio de Actividad Física y Función Muscular — Toledo

Identifiers

NCT: NCT04173715 · CEIC-CHT-568

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗