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NCT Number: NCT04173715

Movement and Behaviours Measurement Study

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Toledo, 45071, Spain

Location status: Recruiting

Location contact

Javier Leal Martín, PhD Student

CONTACT

[email protected]

+34925268800 ext. 96808

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Older Adults Group.

Behavioral

Physical activity and energy expenditure quantification

Low Physical Function Status Group

Behavioral

Physical activity and energy expenditure quantification

Medium Physical Function Status Group

Behavioral

Physical activity and energy expenditure quantification

High Physical Function Status Group

Behavioral

Physical activity and energy expenditure quantification

Primary outcomes

  1. Rest Metabolic Rate

    Time frame: Through study completion, an average of 1 year

    (ml/kg-1/min-1)

  2. Energy expenditure during physical activity performance

    Time frame: Through study completion, an average of 1 year

    (ml/kg-1/min-1)

  3. Accelerometry

    Time frame: Through study completion, an average of 1 year

    Gravitational Units

  4. Physical function

    Time frame: Through study completion, an average of 1 year

    Short Physical Performance Battery

  5. Frailty Status

    Time frame: Through study completion, an average of 1 year

    Fried Frailty Index (0 criteria: Robust; 1-2 criteria: Pre-frail; >2 criteria: Frail) and Frailty Trait Scale (from 0 (best score) to 100 (worst score))

  6. Physical Activity and Sedentary Behaviour Patterns.

    Time frame: Through study completion, an average of 1 year

    Accelerometers

Secondary outcomes

  1. Heart Rate

    Time frame: Through study completion, an average of 1 year

    (bpm)

  2. Body composition

    Time frame: Through study completion, an average of 1 year

    Dual energy X-ray Absorptiometry (DXA)

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Ara Royo

CONTACT

[email protected]

+34 925268800 ext. 5543

Javier Leal Martín

CONTACT

[email protected]

+34 925268800 ext. 96808

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

Registry information

Official study title

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

Acronym: MOBEMENTS

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Nov 22, 2019
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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