Multifactorial Falls Prevention Program - Brazil

April 13, 2020 updated by: Luiz Eugenio Garcez Leme, University of Sao Paulo

Effectiveness of a Multifactorial Falls Prevention Program in Community-dwelling Older People When Compared to Usual Care: A Randomized, Controlled Trial

This study is a clinical trial designed to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls.

A multifactorial falls prevention program consisting of an individualized medical management of the modifiable risk factors, a progressive on-site body balance exercise plus a home-based exercise program, an educational/behavioral intervention and a fall prevention booklet will reduce the number of falls and fall rates when compared with usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter parallel-group randomized trial among community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in Sao Paulo - Brazil and will be randomly allocated to a control group or an intervention group.

Study Type

Interventional

Enrollment (Actual)

612

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • University of Sao Paulo - Orthopedics Institute

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

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Community-dwelling older adults, men and women aged 60 and over who have fallen at least once in the last 12 months

Exclusion Criteria:

  • A previous diagnosis of dementia or a cognitive decline;
  • A previous stroke with a severe neurological impairment;
  • A progressive neurological disease;
  • A severe visual deficiency;
  • Any acute illness that the physician considers as an exercise contra-indication;
  • An acute vertigo or dizziness less than 3 months duration;
  • Inability to keep on standing, even with the use of a walking aid or other device;
  • Unable to communicate;
  • Those who are engaged in a regular exercise program, including physical therapy, with a frequency of equal to or more than twice a week such as: muscle strengthening, balance or gait exercise, Tai Chi and Yoga

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: usual care
The control group will receive a baseline assessment to identify risk factors for falls and will be referred to their clinicians with a report of individual modifiable risk factors to be managed without any specific guidance: referral to routine services, treatments or any specific orientation will be at the discretion of their primary clinicians. So, further management of each participant in the control group will be individualized, with no specific protocol. Interventions will be recorded. Participants will receive a leaflet with basic orientations for fall prevention.
Other: Usual care
The control group will receive a baseline assessment to identify risk factors for falls and will be referred to their clinicians with a report of individual modifiable risk factors to be managed without any specific guidance: referral to routine services, treatments or any specific orientation will be at the discretion of their primary clinicians. So, further management of each participant in the control group will be individualized, with no specific protocol. Interventions will be recorded. Participants will receive a leaflet with basic orientations for fall prevention.
EXPERIMENTAL: Multifactorial Falls Prevention Program
12 week intervention for 10 to 12 participants with sessions once a week, lasting for 2 hours, consisting of: On-site exercises (progressive body balance exercise program),Home-based exercise program, Educational and Behavioural sessions and management of modifiable risk factors.
Other: On-site exercise
The program will consist of progressive balance, including postural orientation and anticipatory postural adjustments sensory-motor activities, and strengthening exercises to enhance balance and postural control and reduce falls. Exercises in the standing position will be prioritised in order to target balance control.Exercises will be both static and dynamic, and will get progressively more challenging, in order to reach the individual optimal level of balance and strength functional status.
Other Names:
  • balance exercises
  • strengthening exercises
Other: home-based exercise
Participants will be provided with a detailed booklet containing safety precautions, instructions and photographs of exercises for use in exercise sessions at home and will be instructed to do the exercises preferably under the supervision of a relative or caregiver, in a suitable place (with good lighting and ventilation) and using proper support (close to a table or chair, or the corner of a wall). In the first four weeks of intervention the patients will stay for 30 minutes after the therapy sessions in order to learn the home exercises. The exercises will be reviewed, if necessary, after each session till the last week of intervention. All necessary equipment to undertake the exercise program will be provided.
Other Names:
  • balance exercises
  • strengthening exercises
Other: Educational and behavioural
Sessions will address specific environmental and behavioural risk factors delivered by trained health professionals,lasting for 30 minutes and will use appropriate language for lay people.Each meeting will be consisted of a brief introduction on the core day topic with supporting audio-visual or graphic material, followed by group discussion in order to identify the beliefs and attitudes of participants regarding falls and any major restriction or barrier for the implementation of preventive strategies. Participants will be encourage to report their own experiences and beliefs. The activity will always end with the reinforcement of the core message of the session.
Other: Management of modifiable risk factors
Postural hypotension: review of medications that may contribute to postural hypotension;Visual impairment: Participants identified as having visual problems will be referred to an ophthalmologist. The use of four or more medications or the use of psychotropic medication: A review of the risk-benefit of using specific medications will be undertaken, especially psychotropic and anti-hypertensive drugs; Foot problems and shoes: Guidance on the use of proper footwear, nail care and the treatment of cutaneous mycoses will be given; Undernutrition: Participants with a BMI lower than 22 kg / m2 and or a leg calf under 31cm will be oriented to increase their protein and calorie intake and will be referred to a nutritionist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of falls
Time Frame: 12 months
Participants will receive instructions to fill in a monthly fall diary. They will receive telephone calls each month to ask for information regarding falls and its consequences, such as the mechanisms, environmental conditions, place (indoors or outdoors), activity during the fall and consequences.
12 months
proportion of fallers
Time Frame: 12 months
Participants will receive instructions to fill in a monthly fall diary. They will receive telephone calls each month to ask for information regarding falls and its consequences, such as the mechanisms, environmental conditions, place (indoors or outdoors), activity during the fall and consequences.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall-related self-efficacy
Time Frame: baseline, 6 months, 12 months
will be assessed by the Falls Efficacy Scale International, translated and adapted in its Brazilian version
baseline, 6 months, 12 months
Balance: Berg Balance Scale, Alternate step test, sit to stand test
Time Frame: baseline, 6 months and 12 months
Berg Balance Scale Alternate Step Test Sit to stand test
baseline, 6 months and 12 months
Fall risk: Quick Falls Risk Assessment
Time Frame: baseline, 6 months, 12 months
Quick Screen Clinical Falls Risk Assessment
baseline, 6 months, 12 months
The level of difficulty with daily tasks
Time Frame: baseline, 6 months, 12 months
Brazilian OARS Multidimensional Functional Assessment Questionnaire (BOMFAQ)
baseline, 6 months, 12 months
Services use
Time Frame: 6 months, 12 months
number of visits to emergency units, hospitalisation (frequency and time) that each participant will have to treat a fall and or it consequences.
6 months, 12 months
Strength: Grip Strength with a dynamometer
Time Frame: Strength
Hand grip strength
Strength

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

University of Sao Paulo General Hospital
Universidade Cidade de Sao Paulo
The George Institute

Investigators

  • Principal Investigator: Monica R Perracini, PT, PhD, Universidade Cidade de Sao Paulo
  • Study Director: Luiz Eugenio G Leme, MD, PhD, University of Sao Paulo
  • Study Chair: Sergio O Paschoal, MD, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2013

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 20, 2019

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (ESTIMATE)

October 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAPPesq 0145/11

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.

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