Prospective Study and Analysis of Biomechanical Parameters of Human Movement Based on Disability Indicators in Older Adults (MOBA-P)

December 12, 2022 updated by: Juliana dos Santos Moreira, Polytechnic Institute of Porto

Study and Analysis of Biomechanical Parameters of Human Movement Based on Disability Indicators in Older Adults Based on a Multifactorial Analysis: a Prospective Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juliana S Moreira, Msc
  • Phone Number: +351 222 061 000
  • Email: jmo@ess.ipp.pt

Study Locations

      • Porto, Portugal, 4200
        • Recruiting
        • Center for Rehabilitation Research, School of Health, Polytechnic of Porto, Portugal
        • Contact:
          • Juliana S Moreira, Msc
          • Phone Number: +351 222 061 000
          • Email: jmo@ess.ipp.pt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Portuguese community-dwelling older adults

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy older Adults
Healthy older Adults: older adults without disability indicators
Disability status assessed by functional measures
Disability Older Adults
Disability Older Adults: older adults with disability indicators
Disability status assessed by functional measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waveforms from full-body joint angles
Time Frame: Assessed once at study entry.
Waveforms from full-body joint angles measured in degrees (°)
Assessed once at study entry.
Waveform from full-body angular joint velocities
Time Frame: Assessed once at study entry
Waveform from angular joint velocities measured in degrees per second (°/s)
Assessed once at study entry
Waveform from lower limb joint moments
Time Frame: Assessed once at study entry
Waveform from lower limb joint moments measured in Newton-meter (kgm²/s²)
Assessed once at study entry
Waveform from total body energy
Time Frame: Assessed once at study entry
Waveform from total body energy measured in joules (J)
Assessed once at study entry
Waveform from full-body separate segment energy
Time Frame: Assessed once at study entry
Waveform from body segment energy un joules (J)
Assessed once at study entry
Waveform from lower body joint forces
Time Frame: Assessed once at study entry
Waveform from lower body joint forces measured in Newton (N)
Assessed once at study entry
Waveform from lower body joint power
Time Frame: Assessed once at study entry
Waveform from lower body joint power measured in Watts
Assessed once at study entry
Waveform from centre of mass displacement
Time Frame: Assessed once at study entry
Waveform from centre of mass displacement in m/s
Assessed once at study entry
Waveform from centre of pressure displacement
Time Frame: Assessed once at study entry
Waveform from centre of pressure displacement in m/s
Assessed once at study entry
International Physical Activity Questionnaire
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
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)
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
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
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
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
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
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
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
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
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
Total number and description of ocurrences of falls
Assessed at study entry and evaluated every three months until the end of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

May 31, 2024

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CE0077C
  • 2020.05356.BD (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia, NORTE 2020, FSE EU)
  • UIDB/05210/2020 (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia (FCT), Portugal and the European Union (EU))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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