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Completed

NCT Number: NCT04606667

Multicomponent Exercise in the Functionality of the Elderly in the Community

Evaluate the results of the implementation of a multicomponent exercise program (16 weeks) for elder community dwelling population on their functionality (via cognitive, balance and mobility status).

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola Superior de Saúde

Vila Nova de Gaia, Porto District, 4405-678, Portugal

About this study

A quasi-experimental study, of the pre-test-post-test type, with a sample for convenience from in a cohort of elderly community dwelling people, carried out between 2009 and 2011. The general objective is to verify the impact of a physical exercise program organized in classes, under the supervision of physiotherapists.The specific objectives are to analyze the effect after 8 and 16 weeks, on the functionality of the elderly person, discriminating three conditions: cognitive state, balance and functional mobility.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be supported by day centers or collective residences linked to the "Project + City",
  • not having regular exercise habits,
  • ability to walk (with or without assistance).

Exclusion criteria

  • not being collaborative,
  • missing the classes three times.

Treatment and study plan

exercise program

Other

Exercise program

Primary outcomes

  1. Functional mobility change

    Time frame: Baseline, 8 weeks, 16 weeks

    Timed Up and Go Test is a validated test that consists on a timed 3 meter defined circuit after getting up from a chair and sitting in it. The categories of achievement are three: less than 10 seconds "without compromise", corresponding to normal performance; between 10.01 and 20 seconds it is considered "slight impairment or normal time for frail elderly"; more than 20.01 seconds corresponds to a degree of "functional impairment" that requires a more detailed assessment.

  2. Balance change

    Time frame: Baseline, 8 weeks, 16 weeks

    Berg scale is a validated instrument to assess balance and the risk of falling associated with its loss. From 56 to 54 points, each point less is associated with a 3 to 4% increase in the risk of falling, from 54 to 46 a change in one point is associated with a 6 to 8% increase in the risk of falling, and below 36 points the risk of falling is very close to 100%, which allows the results to be divided into 4 balance categories: "Total balance problem" (≤36 points); "Serious balance problem" (37-45 points); "Moderate balance problem" (46-53 points) and "normal balance" (≥54 points).

  3. Cognitive status change

    Time frame: Baseline, 8 weeks, 16 weeks

    Mini mental exam scale is a validate instrument to assess the cognitive function and the detection of potential dementia. Individuals are classified into three categories: a score equal to or less than 18 points corresponds to "severe cognitive impairment"; from 19 to 23 points "moderate cognitive impairment" and 24 or more points "normal cognitive state. The literature states that for the diagnosis of dementia, the scale results must be cross-checked with schooling, however when the objective is not to diagnose dementia, but only to characterize and assess changes in cognitive status, the crossing of the scale results with schooling does not justified.

Sponsors and collaborators

Lead sponsor

Instituto Piaget

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2020
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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