Movement and Behaviours Measurement Study

Aging Clinical Trial

— MOBEMENTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04173715
• Other study ID #: CEIC-CHT-568
• Status: Recruiting
• Start date: October 14, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Castilla-La Mancha
• Contact: Ignacio Ara Royo
• Phone: +34 925268800
• Email: Ignacio.Ara[@]uclm.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Frailty
• Frailty Syndrome
• Lifestyle, Sedentary
• Physical Disability
• Physical Function

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad de Castilla-La Mancha, Laboratorio de Actividad Física y Función Muscular	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Consorcio Centro de Investigación Biomédica en Red (CIBER)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rest Metabolic Rate	(ml/kg-1/min-1)	Through study completion, an average of 1 year
Primary	Energy expenditure during physical activity performance	(ml/kg-1/min-1)	Through study completion, an average of 1 year
Primary	Accelerometry	Gravitational Units	Through study completion, an average of 1 year
Primary	Physical function	Short Physical Performance Battery	Through study completion, an average of 1 year
Primary	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
Primary	Physical Activity and Sedentary Behaviour Patterns.	Accelerometers	Through study completion, an average of 1 year
Secondary	Heart Rate	(bpm)	Through study completion, an average of 1 year
Secondary	Body composition	Dual energy X-ray Absorptiometry (DXA)	Through study completion, an average of 1 year