Multifactorial Falls Prevention Program - Brazil

University of Sao Paulo

Status: Completed

Conditions: Accidental Falls

Treatments: Other: Usual care; Other: Educational and behavioural; Other: Management of modifiable risk factors; Other: On-site exercise; Other: home-based exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01698580

CAPPesq 0145/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 612 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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612 participants in 2 patient groups

usual care

Active Comparator group

Description:

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.

Treatment:

Other: Usual care

Multifactorial Falls Prevention Program

Experimental group

Description:

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.

Treatment:

Other: home-based exercise

Other: On-site exercise

Other: Management of modifiable risk factors

Other: Educational and behavioural