NCT03566719

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

April 18, 2018

Last Update Submit

June 12, 2018

Conditions

Keywords

PreventionActive AgeingFallFall RiskExercise Programs

Outcome Measures

Primary Outcomes (7)

  • Change from baseline Force Platform at 4 months

    Static balance

    0 and 4 months

  • Change from baseline Timed Up&Go at 4 months

    Dynamic balance

    0 and 4 months

  • Change from baseline Step test at 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

    Walking speed

    0 and 4 months

  • 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

  • Change from baseline Self efficacy for exercise at 4 months

    Self efficacy for exercise

    0 and 4 months

  • Change from baseline Exercise program adherence at 4 months

    Exercise program adherence 8number of sessions)

    0 and 4 months

Study Arms (2)

Intervention group

EXPERIMENTAL
Other: Exercise program

Control group

NO INTERVENTION

Interventions

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

Intervention group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age equal or superior to 55
  • community dwelling individuals

You may not qualify if:

  • comprehension deficit
  • significative heart disease
  • restrictive breath disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anabela C Martins, PhD

    IPC ESTeSC Coimbra Health School

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

April 18, 2018

First Posted

June 25, 2018

Study Start

September 1, 2015

Primary Completion

January 1, 2016

Study Completion

June 30, 2016

Last Updated

June 25, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share