<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01698580</url>
  </required_header>
  <id_info>
    <org_study_id>CAPPesq 0145/11</org_study_id>
    <nct_id>NCT01698580</nct_id>
  </id_info>
  <brief_title>Multifactorial Falls Prevention Program - Brazil</brief_title>
  <official_title>Effectiveness of a Multifactorial Falls Prevention Program in Community-dwelling Older People When Compared to Usual Care: A Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade Cidade de Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The George Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a clinical trial designed to evaluate the effectiveness of a multifactorial&#xD;
      falls prevention program in reducing the rate of falls.&#xD;
&#xD;
      A multifactorial falls prevention program consisting of an individualized medical management&#xD;
      of the modifiable risk factors, a progressive on-site body balance exercise plus a home-based&#xD;
      exercise program, an educational/behavioral intervention and a fall prevention booklet will&#xD;
      reduce the number of falls and fall rates when compared with usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicenter parallel-group randomized trial among community-dwelling men and&#xD;
      women aged 60 years and over, who have fallen at least once in the previous year.&#xD;
      Participants will be recruited in multiple settings in Sao Paulo - Brazil and will be&#xD;
      randomly allocated to a control group or an intervention group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rate of falls</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>proportion of fallers</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fall-related self-efficacy</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>will be assessed by the Falls Efficacy Scale International, translated and adapted in its Brazilian version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance: Berg Balance Scale, Alternate step test, sit to stand test</measure>
    <time_frame>baseline, 6 months and 12 months</time_frame>
    <description>Berg Balance Scale Alternate Step Test Sit to stand test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall risk: Quick Falls Risk Assessment</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>Quick Screen Clinical Falls Risk Assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of difficulty with daily tasks</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>Brazilian OARS Multidimensional Functional Assessment Questionnaire (BOMFAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Services use</measure>
    <time_frame>6 months, 12 months</time_frame>
    <description>number of visits to emergency units, hospitalisation (frequency and time) that each participant will have to treat a fall and or it consequences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength: Grip Strength with a dynamometer</measure>
    <time_frame>Strength</time_frame>
    <description>Hand grip strength</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">612</enrollment>
  <condition>Accidental Falls</condition>
  <arm_group>
    <arm_group_label>usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multifactorial Falls Prevention Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>On-site exercise</intervention_name>
    <description>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.</description>
    <arm_group_label>Multifactorial Falls Prevention Program</arm_group_label>
    <other_name>balance exercises</other_name>
    <other_name>strengthening exercises</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>home-based exercise</intervention_name>
    <description>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.</description>
    <arm_group_label>Multifactorial Falls Prevention Program</arm_group_label>
    <other_name>balance exercises</other_name>
    <other_name>strengthening exercises</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational and behavioural</intervention_name>
    <description>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.</description>
    <arm_group_label>Multifactorial Falls Prevention Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Management of modifiable risk factors</intervention_name>
    <description>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.</description>
    <arm_group_label>Multifactorial Falls Prevention Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <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.</description>
    <arm_group_label>usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Community-dwelling older adults, men and women aged 60 and over who have fallen at&#xD;
             least once in the last 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A previous diagnosis of dementia or a cognitive decline;&#xD;
&#xD;
          -  A previous stroke with a severe neurological impairment;&#xD;
&#xD;
          -  A progressive neurological disease;&#xD;
&#xD;
          -  A severe visual deficiency;&#xD;
&#xD;
          -  Any acute illness that the physician considers as an exercise contra-indication;&#xD;
&#xD;
          -  An acute vertigo or dizziness less than 3 months duration;&#xD;
&#xD;
          -  Inability to keep on standing, even with the use of a walking aid or other device;&#xD;
&#xD;
          -  Unable to communicate;&#xD;
&#xD;
          -  Those who are engaged in a regular exercise program, including physical therapy, with&#xD;
             a frequency of equal to or more than twice a week such as: muscle strengthening,&#xD;
             balance or gait exercise, Tai Chi and Yoga&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monica R Perracini, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Cidade de Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luiz Eugenio G Leme, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergio O Paschoal, MD, PhD</last_name>
    <role>Study Chair</role>
  </overall_official>
  <location>
    <facility>
      <name>University of Sao Paulo - Orthopedics Institute</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>April 13, 2020</last_update_submitted>
  <last_update_submitted_qc>April 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Luiz Eugenio Garcez Leme</investigator_full_name>
    <investigator_title>MD, PhD Professor</investigator_title>
  </responsible_party>
  <keyword>accidental falls</keyword>
  <keyword>aged</keyword>
  <keyword>aged, 80 and over</keyword>
  <keyword>prevention and control</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698580
org study id: CAPPesq 0145/11
nct id: NCT01698580
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: rate of falls
time frame: 12 months
description: 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.
measure: proportion of fallers
time frame: 12 months
description: 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.
measure: Fall-related self-efficacy
time frame: baseline, 6 months, 12 months
description: will be assessed by the Falls Efficacy Scale International, translated and adapted in its Brazilian version
measure: Balance: Berg Balance Scale, Alternate step test, sit to stand test
time frame: baseline, 6 months and 12 months
description: Berg Balance Scale Alternate Step Test Sit to stand test
measure: Fall risk: Quick Falls Risk Assessment
time frame: baseline, 6 months, 12 months
description: Quick Screen Clinical Falls Risk Assessment
measure: The level of difficulty with daily tasks
time frame: baseline, 6 months, 12 months
description: Brazilian OARS Multidimensional Functional Assessment Questionnaire (BOMFAQ)
measure: Services use
time frame: 6 months, 12 months
description: number of visits to emergency units, hospitalisation (frequency and time) that each participant will have to treat a fall and or it consequences.
measure: Strength: Grip Strength with a dynamometer
time frame: Strength
description: Hand grip strength
arm group label: usual care
arm group type: Active Comparator
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.
arm group label: Multifactorial Falls Prevention Program
arm group type: Experimental
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.
intervention type: Other
intervention name: On-site exercise
description: 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.
arm group label: Multifactorial Falls Prevention Program
other name: balance exercises
other name: strengthening exercises
intervention type: Other
intervention name: home-based exercise
description: 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.
arm group label: Multifactorial Falls Prevention Program
other name: balance exercises
other name: strengthening exercises
intervention type: Other
intervention name: Educational and behavioural
description: 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.
arm group label: Multifactorial Falls Prevention Program
intervention type: Other
intervention name: Management of modifiable risk factors
description: 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.
arm group label: Multifactorial Falls Prevention Program
intervention type: Other
intervention name: Usual care
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.
arm group label: usual care
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Monica R Perracini, PT, PhD
role: Principal Investigator
affiliation: Universidade Cidade de Sao Paulo
last name: Luiz Eugenio G Leme, MD, PhD
role: Study Director
affiliation: University of Sao Paulo
last name: Sergio O Paschoal, MD, PhD
role: Study Chair
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Luiz Eugenio Garcez Leme
investigator title: MD, PhD Professor