Movement and Behaviours Measurement Study (MOBEMENTS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Physical Disability; Frailty Syndrome; Physical Function; Lifestyle, Sedentary
• Intervention / Treatment: Behavioral: Older Adults Group.; Behavioral: Low Physical Function Status Group; Behavioral: Medium Physical Function Status Group; Behavioral: High Physical Function Status Group

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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Ignacio Ara Royo; Phone Number: 5543 +34 925268800; Email: Ignacio.Ara@uclm.es
• Study Contact Backup: Name: Javier Leal Martín; Phone Number: 96808 +34 925268800; Email: javier.leal@uclm.es

Study Locations

• Spain
  • Toledo, Spain, 45071
    • Recruiting
    • Universidad de Castilla-La Mancha, Laboratorio de Actividad Física y Función Muscular
    • Contact: Javier Leal Martín, PhD Student; Phone Number: 96808 +34925268800; Email: javier.leal@uclm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

People over 65 years old will be enrolled in the study. They will be recruited from the Frailty Consultation in the Virgen del Valle Hospital from Toledo (Spain).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General Group; All those who are over 65 years old and capable of walking by themselves.	Behavioral: Older Adults Group.; 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.	Behavioral: Low Physical Function Status Group; Physical activity and energy expenditure quantification; Behavioral: Medium Physical Function Status Group; 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.	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
High Physical Function Status Group.; All those who present a high physical function status will be included in this group.	Behavioral: High Physical Function Status Group; Physical activity and energy expenditure quantification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rest Metabolic Rate	(ml/kg-1/min-1)	Through study completion, an average of 1 year
Energy expenditure during physical activity performance	(ml/kg-1/min-1)	Through study completion, an average of 1 year
Accelerometry	Gravitational Units	Through study completion, an average of 1 year
Physical function	Short Physical Performance Battery	Through study completion, an average of 1 year
Frailty Status	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))	Through study completion, an average of 1 year
Physical Activity and Sedentary Behaviour Patterns.	Accelerometers	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	(bpm)	Through study completion, an average of 1 year
Body composition	Dual energy X-ray Absorptiometry (DXA)	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Consorcio Centro de Investigación Biomédica en Red (CIBER)
• Investigators: Principal Investigator: Ignacio Ara Royo, Univeristy of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Physical Function; Aging; Accelerometry; Energy Expenditure; Frailty Syndrome; Cut-Points; Physical Activity Quantification
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: CEIC-CHT-568

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No