Multifactorial Falls Prevention Program - Brazil

Not Applicable

Completed

• Conditions: Accidental Falls

• Registration Number: NCT01698580
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-03
• Study Start: 2013-12
• Primary Completion: 2019-12
• Study Completion: 2019-12-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 612

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
rate of falls	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.
proportion of fallers	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.

Secondary Outcome Measures

Name	Time	Method
The level of difficulty with daily tasks	baseline, 6 months, 12 months	Brazilian OARS Multidimensional Functional Assessment Questionnaire (BOMFAQ)
Strength: Grip Strength with a dynamometer	Strength	Hand grip strength
Fall-related self-efficacy	baseline, 6 months, 12 months	will be assessed by the Falls Efficacy Scale International, translated and adapted in its Brazilian version
Balance: Berg Balance Scale, Alternate step test, sit to stand test	baseline, 6 months and 12 months	Berg Balance Scale Alternate Step Test Sit to stand test
Fall risk: Quick Falls Risk Assessment	baseline, 6 months, 12 months	Quick Screen Clinical Falls Risk Assessment
Services use	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.

Trial Locations

Locations (1)

University of Sao Paulo - Orthopedics Institute; 🇧🇷 Sao Paulo, Brazil