NCT05656690

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

November 18, 2022

Last Update Submit

November 5, 2024

Conditions

Outcome Measures

Primary Outcomes (15)

  • Waveforms from full-body joint angles

    Waveforms from full-body joint angles measured in degrees (°)

    Assessed once at study entry.

  • Waveform from full-body angular joint velocities

    Waveform from angular joint velocities measured in degrees per second (°/s)

    Assessed once at study entry

  • Waveform from lower limb joint moments

    Waveform from lower limb joint moments measured in Newton-meter (kgm²/s²)

    Assessed once at study entry

  • Waveform from total body energy

    Waveform from total body energy measured in joules (J)

    Assessed once at study entry

  • Waveform from full-body separate segment energy

    Waveform from body segment energy un joules (J)

    Assessed once at study entry

  • Waveform from lower body joint forces

    Waveform from lower body joint forces measured in Newton (N)

    Assessed once at study entry

  • Waveform from lower body joint power

    Waveform from lower body joint power measured in Watts

    Assessed once at study entry

  • Waveform from centre of mass displacement

    Waveform from centre of mass displacement in m/s

    Assessed once at study entry

  • Waveform from centre of pressure displacement

    Waveform from centre of pressure displacement in m/s

    Assessed once at study entry

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Healthy older Adults

Healthy older Adults: older adults without disability indicators

Other: Exposure to disability

Disability Older Adults

Disability Older Adults: older adults with disability indicators

Other: Exposure to disability

Interventions

Disability status assessed by functional measures

Disability Older AdultsHealthy older Adults

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Portuguese community-dwelling older adults

You may qualify if:

  • older adults, 60 years or over;
  • community-dwelling;
  • able to perform the tasks (gait, sit-to-stand, climb and descend stairs) independently;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Rehabilitation Research, School of Health, Polytechnic of Porto, Portugal

Porto, 4200, Portugal

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD grant student

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 19, 2022

Study Start

May 1, 2022

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations