Movement and Behaviours Measurement Study

NCT04173715 | Recruiting DMC

• 1 other identifier: CEIC-CHT-568
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Cut-Points; Accelerometry; Physical Activity Quantification; Physical Function; Frailty Syndrome; Energy Expenditure; Aging

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Heart Rate

  Through study completion, an average of 1 year

• Body composition

  Through study completion, an average of 1 year

Study Arms (4)

General Group

All those who are over 65 years old and capable of walking by themselves.

Behavioral: Older Adults Group.

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; Behavioral: Medium Physical Function Status Group

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

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

Interventions

Older Adults Group. BEHAVIORAL

Physical activity and energy expenditure quantification

General Group

Low Physical Function Status Group BEHAVIORAL

Physical activity and energy expenditure quantification

Low Physical Function Status Group.; Medium Physical Function Status Group.

Medium Physical Function Status Group BEHAVIORAL

Physical activity and energy expenditure quantification

Low Physical Function Status Group.; Medium Physical Function Status Group.

High Physical Function Status Group BEHAVIORAL

Physical activity and energy expenditure quantification

High Physical Function Status Group.; Medium Physical Function Status Group.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

• years and older
• Non-institutionalized
• Physical function assessment (SPPB\>3)

You may not qualify if:

• Have started an exercise program.
• Mini-Mental Score \< 18.
• Presenting any physical activity contraindication.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator

Study Sites (1)

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

Toledo, 45071, Spain

RECRUITING

MeSH Terms

Conditions

Frailty; Sedentary Behavior

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Ignacio Ara Royo

  Univeristy of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignacio Ara Royo

CONTACT

+34 925268800; Ignacio.Ara@uclm.es

Javier Leal Martín

CONTACT

+34 925268800; javier.leal@uclm.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 22, 2019
• Study Start: October 14, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

ES (1)