Clinical trial NCT01698580: Multifactorial Falls Prevention Program - Brazil
Official title: Effectiveness of a Multifactorial Falls Prevention Program in Community-dwelling Older People When Compared to Usual Care: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: accidental falls
aged
aged, 80 and over
prevention and control
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Universidade Cidade de Sao Paulo
name: University of Sao Paulo General Hospital
name: The George Institute
First posted: 2012-10-03
Enrollment: 612
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of falls
timeFrame: 12 months
measure: proportion of fallers
timeFrame: 12 months
Secondary outcomes:
measure: Fall-related self-efficacy
timeFrame: baseline, 6 months, 12 months
measure: Balance: Berg Balance Scale, Alternate step test, sit to stand test
timeFrame: baseline, 6 months and 12 months
measure: Fall risk: Quick Falls Risk Assessment
timeFrame: baseline, 6 months, 12 months
measure: The level of difficulty with daily tasks
timeFrame: baseline, 6 months, 12 months
measure: Services use
timeFrame: 6 months, 12 months
measure: Strength: Grip Strength with a dynamometer
timeFrame: Strength
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo - Orthopedics Institute
Study officials:
affiliation: Universidade Cidade de Sao Paulo
name: Monica R Perracini, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Luiz Eugenio G Leme, MD, PhD
role: STUDY_DIRECTOR
name: Sergio O Paschoal, MD, PhD
role: STUDY_CHAIR
References:
citation: de Negreiros Cabral K, Perracini MR, Soares AT, de Cristo Stein F, Sera CT, Tiedemann A, Sherrington C, Filho WJ, Paschoal SM. Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: study protocol for a randomised controlled trial (Prevquedas Brazil). BMC Geriatr. 2013 Mar 15;13:27. doi: 10.1186/1471-2318-13-27.