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ElderlyNCT03566719

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

A study testing Exercise program in people with Elderly and Fall Risk, run by Sara Lúcia Morgado Martins.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Elderly, Fall Risk, Fall
What is being tested?
Exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
Sep 2015to 30 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age equal or superior to 55
  • community dwelling individuals

Who cannot join

  • comprehension deficit
  • significative heart disease
  • restrictive breath disease

About this study

Official title: 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.

Conditions
Elderly, Fall Risk, Fall
Being tested
Exercise program
Keywords
Prevention, Active Ageing, Fall, Fall Risk, Exercise Programs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise programOther

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

Study groups in NCT03566719
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Other: Exercise program
Control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Force Platform at 4 months

    Static balance

    Measured: 0 and 4 months

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

    Dynamic balance

    Measured: 0 and 4 months

  3. Change from baseline Step test at 4 months

    Muscular strength, motor coordination e inferior limb's agility

    Measured: 0 and 4 months

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

    Walking speed

    Measured: 0 and 4 months

  5. Change from baseline FES at 4 months

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

    Measured: 0 and 4 months

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

    Self efficacy for exercise

    Measured: 0 and 4 months

  7. Change from baseline Exercise program adherence at 4 months

    Exercise program adherence 8number of sessions)

    Measured: 0 and 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2018
  2. Study startSep 2015
  3. Primary completionJan 2016
  4. Study completion30 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03566719
Sponsor's protocol ID
hdl.handle.net/10400.26/22351
Status last verified
Jun 2018
First submitted
18 Apr 2018
Last updated
25 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Exercise program in people with Elderly and Fall Risk, run by Sara Lúcia Morgado Martins.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Force Platform at 4 months (time frame: 0 and 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03566719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.

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