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OpenTrials
Completed

NCT Number: NCT03566719

Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults

Background: Falls are a problem among the elderly population, it is known that currently about 30% of people over 65 years falls every year. The European Union estimates a cost of € 281 per inhabitant per year and a cost of € 25 billion per year for health care1 which translates into a significant economic impact. The World Health Organization2 argues that it is possible to reduce these costs through prevention and health promotion strategies. For this, it is important to raise awareness, evaluate risk factors and identify and implement intervention programs. Objective: To test the effect of an exercise program on the prevention of risk of fall. Methods: This study, which lasted 4 months, was experimental, prospective. The experimental group (EG) performed an exercise program and the control group (CG) maintained their usual routine. For the measurement and evaluation of the variables under study, were used: sociodemographic data questionnaire, self-efficacy for exercise scale, Portuguese version of the falls efficacy scale (FES), 10m walking speed (WS), Timed Up & Go test (TUG), step test and Hercules® Force Platform (static balance). A significance level of 5% (p ≤ 0.05) was considered for all comparisons.

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Key information

Conditions

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age equal or superior to 55
  • community dwelling individuals

Exclusion criteria

  • comprehension deficit
  • significative heart disease
  • restrictive breath disease

Treatment and study plan

exercise program

Other

Intervention group has been submitted to an exercise program directed to prevent and reduce fall risk

Primary outcomes

  1. Change from baseline Force Platform at 4 months

    Time frame: 0 and 4 months

    Static balance

  2. Change from baseline Timed Up&Go at 4 months

    Time frame: 0 and 4 months

    Dynamic balance

  3. Change from baseline Step test at 4 months

    Time frame: 0 and 4 months

    Muscular strength, motor coordination e inferior limb's agility

  4. Change from baseline 10-meters walking test at 4 months

    Time frame: 0 and 4 months

    Walking speed

  5. Change from baseline FES at 4 months

    Time frame: 0 and 4 months

    Fear of falling related by individuals and by their Daily live activity's execution

  6. Change from baseline Self efficacy for exercise at 4 months

    Time frame: 0 and 4 months

    Self efficacy for exercise

  7. Change from baseline Exercise program adherence at 4 months

    Time frame: 0 and 4 months

    Exercise program adherence 8number of sessions)

Sponsors and collaborators

Lead sponsor

Sara Lúcia Morgado Martins

Other

Registry information

Official study title

Effectiveness of an Exercise Program for Prevention of Risk of Fall in a Community Dwelling Adults Over 55 Years

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2018
Registry last updated
Jun 25, 2018

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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