AgingMOBEMENTSNCT04173715
Movement and Behaviours Measurement Study
An observational study of Aging and Physical Function, run by University of Castilla-La Mancha at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Physical Function, Frailty Syndrome
- What is being tested?
- Older Adults Group., Low Physical Function Status Group and Medium Physical Function Status Group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 14 Oct 2019to 31 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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).
Who may be able to join
- 65 years and older
- Non-institutionalized
- Physical function assessment (SPPB>3)
Who cannot join
- Have started an exercise program.
- Mini-Mental Score < 18.
- Presenting any physical activity contraindication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Castilla-La Mancha, Laboratorio de Actividad Física y Función Muscular
Toledo, 45071
Javier Leal Martín, PhD Student, +34925268800 ext. 96808, javier.leal@uclm.es
About this study
Official title: 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.
Read the 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.
- Being tested
- Older Adults Group., Low Physical Function Status Group, Medium Physical Function Status Group, High Physical Function Status Group
- Keywords
- Cut-Points, Accelerometry, Physical Activity Quantification, Physical Function, Frailty Syndrome, Energy Expenditure, Aging
- Medical subject headings
- Frailty, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Older Adults Group.Behavioural
Physical activity and energy expenditure quantification
Low Physical Function Status GroupBehavioural
Physical activity and energy expenditure quantification
Medium Physical Function Status GroupBehavioural
Physical activity and energy expenditure quantification
High Physical Function Status GroupBehavioural
Physical activity and energy expenditure quantification
| Study group | Role | What they receive |
|---|---|---|
| General Group | All those who are over 65 years old and capable of walking by themselves. Receives: Behavioral: Older Adults Group. | |
| Low Physical Function Status Group. | All those who present a low physical function status will be included in this group. Receives: 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. Receives: 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. Receives: Behavioral: High Physical Function Status Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rest Metabolic Rate
(ml/kg-1/min-1)
Measured: Through study completion, an average of 1 year
Energy expenditure during physical activity performance
(ml/kg-1/min-1)
Measured: Through study completion, an average of 1 year
Accelerometry
Gravitational Units
Measured: Through study completion, an average of 1 year
Physical function
Short Physical Performance Battery
Measured: 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))
Measured: Through study completion, an average of 1 year
Physical Activity and Sedentary Behaviour Patterns.
Accelerometers
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Heart Rate
(bpm)
Measured: Through study completion, an average of 1 year
Body composition
Dual energy X-ray Absorptiometry (DXA)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start14 Oct 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Responsible party
- Principal investigator, Ignacio Ara, University of Castilla-La Mancha
- Investigators
- Ignacio Ara Royo, Principal investigator, Univeristy of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173715
- Sponsor's protocol ID
- CEIC-CHT-568
- Acronym
- MOBEMENTS
- Status last verified
- May 2024
- First submitted
- 31 Oct 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Cut-points to Estimate Sedentary Time and Physical Activity Intensities in Older Adults
- ClinicalTrials.gov ID
- NCT04173715
- Acronym / sponsor ID
- MOBEMENTS / CEIC-CHT-568
- Keywords
- Cut-Points, Accelerometry, Physical Activity Quantification, Physical Function, Frailty Syndrome, Energy Expenditure, Aging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| General Group | – | Behavioral: Older Adults Group.All those who are over 65 years old and capable of walking by themselves. |
| Low Physical Function Status Group. | – | Behavioral: Low Physical Function Status Group, Behavioral: Medium Physical Function Status GroupAll those who present a low physical function status will be included in this group. |
| Medium Physical Function Status Group. | – | Behavioral: Low Physical Function Status Group, Behavioral: Medium Physical Function Status Group, Behavioral: High Physical Function Status GroupAll those who present a medium physical function status will be included in this group. |
| High Physical Function Status Group. | – | Behavioral: High Physical Function Status GroupAll those who present a high physical function status will be included in this group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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).
Key inclusion criteria (3 listed)
- 65 years and older
- Non-institutionalized
- Physical function assessment (SPPB>3)
Key exclusion criteria (3 listed)
- Have started an exercise program.
- Mini-Mental Score < 18.
- Presenting any physical activity contraindication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Older Adults Group.Physical activity and energy expenditure quantification | Behavioural | General Group |
| Low Physical Function Status GroupPhysical activity and energy expenditure quantification | Behavioural | Low Physical Function Status Group., Medium Physical Function Status Group. |
| Medium Physical Function Status GroupPhysical activity and energy expenditure quantification | Behavioural | Low Physical Function Status Group., Medium Physical Function Status Group. |
| High Physical Function Status GroupPhysical activity and energy expenditure quantification | Behavioural | High Physical Function Status Group., Medium Physical Function Status Group. |
Primary outcome
Rest Metabolic Rate
Time frame: Through study completion, an average of 1 year
(ml/kg-1/min-1)
Energy expenditure during physical activity performance
Time frame: Through study completion, an average of 1 year
(ml/kg-1/min-1)
Accelerometry
Time frame: Through study completion, an average of 1 year
Gravitational Units
Physical function
Time frame: Through study completion, an average of 1 year
Short Physical Performance Battery
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))
Physical Activity and Sedentary Behaviour Patterns.
Time frame: Through study completion, an average of 1 year
Accelerometers
2 secondary outcomes
Heart Rate
Time frame: Through study completion, an average of 1 year
Body composition
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ignacio Ara Royo principal investigator
Univeristy of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Physical Function, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Ara Royo (+34 925268800 ext. 5543, Ignacio.Ara@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rest Metabolic Rate (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.