An observational study in Aging, Physical Function and Frailty Syndrome, sponsored by University of Castilla-La Mancha. Recruiting at 1 site in Spain. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Castilla-La Mancha · Observational
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.
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.
1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.
This study's planned enrollment of 90 is below the median of 211 across 503 observational studies indexed under Frailty.
Browse Frailty studies →University of Castilla-La Mancha is the lead sponsor of 107 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All those who are over 65 years old and capable of walking by themselves.
Behavioral: Older Adults Group.
All those who present a low physical function status will be included in this group.
Behavioral: Low Physical Function Status Group · Behavioral: 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 · Behavioral: Medium Physical Function Status Group · Behavioral: 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
Physical activity and energy expenditure quantification
Physical activity and energy expenditure quantification
Physical activity and energy expenditure quantification
Rest Metabolic Rate
(ml/kg-1/min-1)
Time frame: Through study completion, an average of 1 year
Energy expenditure during physical activity performance
(ml/kg-1/min-1)
Time frame: Through study completion, an average of 1 year
Accelerometry
Gravitational Units
Time frame: Through study completion, an average of 1 year
Physical function
Short Physical Performance Battery
Time frame: 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))
Time frame: Through study completion, an average of 1 year
Physical Activity and Sedentary Behaviour Patterns.
Accelerometers
Time frame: Through study completion, an average of 1 year
Heart Rate
(bpm)
Time frame: Through study completion, an average of 1 year
Body composition
Dual energy X-ray Absorptiometry (DXA)
Time frame: Through study completion, an average of 1 year
Started Oct 2019 (actual). Primary completion is estimated for Dec 2025, 74 months after the start.
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