Multifactorial Falls Prevention Program - Brazil

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.

Conditions

• Accidental Falls

Interventions

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

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

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.

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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo

  collaborator OTHER

• University of Sao Paulo General Hospital

  collaborator OTHER

• The George Institute

  collaborator OTHER

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Monica R Perracini, PT, PhD · Universidade Cidade de Sao Paulo

• Luiz Eugenio G Leme, MD, PhD · University of Sao Paulo

• Sergio O Paschoal, MD, PhD

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-31

Primary Completion

2019-12-31

Completion

2019-12-20

Countries

• Brazil

Study Locations