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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03566719
Other study ID # hdl.handle.net/10400.26/22351
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date June 30, 2016

Study information

Verified date June 2018
Source Escola Superior de Tecnologia da Saúde de Coimbra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 30, 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

- age equal or superior to 55

- community dwelling individuals

Exclusion Criteria:

- comprehension deficit

- significative heart disease

- restrictive breath disease

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sara Lúcia Morgado Martins

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Force Platform at 4 months Static balance 0 and 4 months
Primary Change from baseline Timed Up&Go at 4 months Dynamic balance 0 and 4 months
Primary Change from baseline Step test at 4 months Muscular strength, motor coordination e inferior limb's agility 0 and 4 months
Primary Change from baseline 10-meters walking test at 4 months Walking speed 0 and 4 months
Primary Change from baseline FES at 4 months Fear of falling related by individuals and by their Daily live activity's execution 0 and 4 months
Primary Change from baseline Self efficacy for exercise at 4 months Self efficacy for exercise 0 and 4 months
Primary Change from baseline Exercise program adherence at 4 months Exercise program adherence 8number of sessions) 0 and 4 months
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