Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults
June 12, 2018 updated by: Sara Lúcia Morgado Martins
Effectiveness of an Exercise Program for Prevention of Risk of Fall in a Community Dwelling Adults Over 55 Years
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
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
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age equal or superior to 55
- community dwelling individuals
Exclusion Criteria:
- comprehension deficit
- significative heart disease
- restrictive breath disease
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
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Intervention group
|
Intervention group has been submitted to an exercise program directed to prevent and reduce fall risk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline Force Platform at 4 months
Time Frame: 0 and 4 months
|
Static balance
|
0 and 4 months
|
|
Change from baseline Timed Up&Go at 4 months
Time Frame: 0 and 4 months
|
Dynamic balance
|
0 and 4 months
|
|
Change from baseline Step test at 4 months
Time Frame: 0 and 4 months
|
Muscular strength, motor coordination e inferior limb's agility
|
0 and 4 months
|
|
Change from baseline 10-meters walking test at 4 months
Time Frame: 0 and 4 months
|
Walking speed
|
0 and 4 months
|
|
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
|
0 and 4 months
|
|
Change from baseline Self efficacy for exercise at 4 months
Time Frame: 0 and 4 months
|
Self efficacy for exercise
|
0 and 4 months
|
|
Change from baseline Exercise program adherence at 4 months
Time Frame: 0 and 4 months
|
Exercise program adherence 8number of sessions)
|
0 and 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Anabela C Martins, PhD, IPC ESTeSC Coimbra Health School
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
September 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
June 30, 2016
Study Registration Dates
First Submitted
April 18, 2018
First Submitted That Met QC Criteria
June 12, 2018
First Posted (Actual)
June 25, 2018
Study Record Updates
Last Update Posted (Actual)
June 25, 2018
Last Update Submitted That Met QC Criteria
June 12, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- hdl.handle.net/10400.26/22351
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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.