Multifactorial Falls Prevention Program - Brazil

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Sao Paulo
Sponsor:
Collaborators:
Universidade Cidade de Sao Paulo
University of Sao Paulo General Hospital
The George Institute
Information provided by (Responsible Party):
Luiz Eugenio Garcez Leme, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01698580
First received: August 30, 2012
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Accidental Falls
Other: On-site exercise
Other: home-based exercise
Other: Educational and behavioural
Other: Management of modifiable risk factors
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of a Multifactorial Falls Prevention Program in Community-dwelling Older People When Compared to Usual Care: A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • rate of falls [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Fall-related self-efficacy [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
    Berg Balance Scale Alternate Step Test Sit to stand test

  • Fall risk: Quick Falls Risk Assessment [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Quick Screen Clinical Falls Risk Assessment

  • The level of difficulty with daily tasks [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Brazilian OARS Multidimensional Functional Assessment Questionnaire (BOMFAQ)

  • Services use [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    number of visits to emergency units, hospitalisation (frequency and time) that each participant will have to treat a fall and or it consequences.

  • Strength: Grip Strength with a dynamometer [ Time Frame: Strength ] [ Designated as safety issue: No ]
    Hand grip strength


Estimated Enrollment: 612
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698580

Contacts
Contact: Monica R Perracini, FT, PhD +551121781310 mrperracini@unicid.br
Contact: Kelem N Cabral, MD, PhD kelemcabral@hotmail.com

Locations
Brazil
University of Sao Paulo - Orthopedics Institute Recruiting
Sao Paulo, Brazil
Contact: Luiz Eugenio G Leme, MD, PhD       lueglem@usp.br   
Contact: Kelem N Cabral, MD       kelemcabral@hotmail.com   
Sub-Investigator: kelem N Cabral, MD         
Sponsors and Collaborators
University of Sao Paulo
Universidade Cidade de Sao Paulo
University of Sao Paulo General Hospital
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
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luiz Eugenio Garcez Leme, MD, PhD Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01698580     History of Changes
Other Study ID Numbers: CAPPesq 0145/11
Study First Received: August 30, 2012
Last Updated: September 30, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
accidental falls
aged
aged, 80 and over
prevention and control

ClinicalTrials.gov processed this record on August 01, 2014