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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05656690
Other study ID # CE0077C
Secondary ID 2020.05356.BDUID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date July 31, 2024

Study information

Verified date December 2022
Source Polytechnic Institute of Porto
Contact Juliana S Moreira, Msc
Phone +351 222 061 000
Email jmo@ess.ipp.pt
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mobility loss in older people is caused by a variety of aging impairments in various body systems.The disability, which includes physical impairments and resulting activity limitations or participation restrictions, can arise acutely from a catastrophic illness or, more commonly, from subacute functional decline without a clear triggering event. Lower physical functioning was associated with higher healthcare utilization and expenditures, leading to a large burden on government-funded healthcare services. Early identification of mobility changes and intervening in them would likely be the most effective strategy to reduce the burden of disability in the population. Overall, there is a need to develop strategies to reduce disability among older adults in which kinetic and kinematic characteristics are used to predict disability status. Accordingly, the purpose of this prospective cohort is to identify biomechanical parameters, from the gait, sit-to-stand, timed up and go, stair ascend and descend, and quiet standing functional tasks, as predictors of changes in health and disability status in older adults. This research was funded by Fundação para a Ciência e Tecnologia (FCT), NORTE 2020, and European Social Fund of European Union, grant number 2020.05356.BD and through R&D Units funding (UIDB/05210/2020), Fundação para a Ciência e Tecnologia (FCT), Portugal and the European Union.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - older adults, 60 years or over; - community-dwelling; - able to perform the tasks (gait, sit-to-stand, climb and descend stairs) independently; Exclusion Criteria: - older adults who are institutionalized; - older adults who have established diagnosis of malignancy or terminal diseases with an anticipated survival of less than 1 year; - older adults who have stroke history, cerebral hemorrhage, head trauma, or Parkinson's disease; - older adults who have cognitive impairment, specifically Mini Mental StateExamination (Portuguese version) score of 22 for 0 to 2 years of literacy, 24 for 3 to6 years of literacy and 27 for more than 6 years of literacy (Morgado et al., 2009); - older adults who have rheumatic pathologies that interfere with the tasks performance; - older adults who have diabetic foot, lower limb fracture less than 6 weeks, or other related conditions; - older adults who have unstable cardiovascular disease, liver or renal function failure; - older adults who have a body mass index greater than or equal to 30 kg/m2; - older adults who vestibular and/or audition or vision impairments non corrected that influence the performance of tasks; - older adults who presence of symptoms at the time of evaluation that influences the participant performance of tasks.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exposure to disability
Disability status assessed by functional measures

Locations

Country Name City State
Portugal Center for Rehabilitation Research, School of Health, Polytechnic of Porto, Portugal Porto

Sponsors (4)

Lead Sponsor Collaborator
Polytechnic Institute of Porto Center for Rehabilitation Research - Polytechnic Institute of Porto (IPP), Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto, School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Waveforms from full-body joint angles Waveforms from full-body joint angles measured in degrees (°) Assessed once at study entry.
Primary Waveform from full-body angular joint velocities Waveform from angular joint velocities measured in degrees per second (°/s) Assessed once at study entry
Primary Waveform from lower limb joint moments Waveform from lower limb joint moments measured in Newton-meter (kgm²/s²) Assessed once at study entry
Primary Waveform from total body energy Waveform from total body energy measured in joules (J) Assessed once at study entry
Primary Waveform from full-body separate segment energy Waveform from body segment energy un joules (J) Assessed once at study entry
Primary Waveform from lower body joint forces Waveform from lower body joint forces measured in Newton (N) Assessed once at study entry
Primary Waveform from lower body joint power Waveform from lower body joint power measured in Watts Assessed once at study entry
Primary Waveform from centre of mass displacement Waveform from centre of mass displacement in m/s Assessed once at study entry
Primary Waveform from centre of pressure displacement Waveform from centre of pressure displacement in m/s Assessed once at study entry
Primary International Physical Activity Questionnaire IPAQ is questionnaire to assess self-reported physical activity Assessed at study entry and evaluated every three months until the end of 1 year
Primary Mini-Mental State Examination (MMSE) MMSE provides a brief screening test that quantitatively assesses the severity of cognitive impairment and documents cognitive changes occurring over time Assessed at study entry and evaluated every three months until the end of 1 year
Primary Barthel Index The Barthel Index is an instrument that assesses the individual's level of independence for ten activities of daily living Assessed at study entry and evaluated every three months until the end of 1 year
Primary Lawton and Brody Instrumental Activities of Daily Living Scale Lawton and Brody Instrumental Activities of Daily Living Scale assess the instrumental ADLs necessary for living in the community Assessed at study entry and evaluated every three months until the end of 1 year
Primary Number of health conditions Total number and description of health conditions Assessed at study entry and evaluated every three months until the end of 1 year
Primary Number of falls Total number and description of ocurrences of falls Assessed at study entry and evaluated every three months until the end of 1 year
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