Accidental FallsNCT01698580
Multifactorial Falls Prevention Program - Brazil
A study testing On-site exercise, home-based exercise and Educational and behavioural in people with Accidental Falls, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- On-site exercise, home-based exercise and Educational and behavioural
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2013to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling older adults, men and women aged 60 and over who have fallen at least once in the last 12 months
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Multifactorial Falls Prevention Program in Community-dwelling Older People When Compared to Usual Care: A Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Accidental Falls
- Being tested
- On-site exercise, home-based exercise, Educational and behavioural, Management of modifiable risk factors, Usual care
- Keywords
- accidental falls, aged, aged, 80 and over, prevention and control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-site exerciseOther
Also called balance exercises, strengthening exercises
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.
home-based exerciseOther
Also called balance exercises, strengthening exercises
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.
Educational and behaviouralOther
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.
Management of modifiable risk factorsOther
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| usual care | Active comparator | 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. Receives: Other: Usual care |
| Multifactorial Falls Prevention Program | Experimental | 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. Receives: Other: On-site exercise; Other: home-based exercise; Other: Educational and behavioural; Other: Management of modifiable risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of falls
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.
Measured: 12 months
proportion of fallers
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.
Measured: 12 months
Secondary outcomes (6)
Fall-related self-efficacy
will be assessed by the Falls Efficacy Scale International, translated and adapted in its Brazilian version
Measured: baseline, 6 months, 12 months
Balance: Berg Balance Scale, Alternate step test, sit to stand test
Berg Balance Scale Alternate Step Test Sit to stand test
Measured: baseline, 6 months and 12 months
Fall risk: Quick Falls Risk Assessment
Quick Screen Clinical Falls Risk Assessment
Measured: baseline, 6 months, 12 months
The level of difficulty with daily tasks
Brazilian OARS Multidimensional Functional Assessment Questionnaire (BOMFAQ)
Measured: baseline, 6 months, 12 months
Services use
number of visits to emergency units, hospitalisation (frequency and time) that each participant will have to treat a fall and or it consequences.
Measured: 6 months, 12 months
Strength: Grip Strength with a dynamometer
Hand grip strength
Measured: Strength
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startDec 2013
- Primary completionDec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Cidade de Sao Paulo, University of Sao Paulo General Hospital, The George Institute
- Responsible party
- Principal investigator, Luiz Eugenio Garcez Leme, University of Sao Paulo
- Investigators
- Monica R Perracini, PT, PhD, Principal investigator, Universidade Cidade de Sao PauloLuiz Eugenio G Leme, MD, PhD, Study director, University of Sao PauloSergio O Paschoal, MD, PhD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698580
- Sponsor's protocol ID
- CAPPesq 0145/11
- Status last verified
- Apr 2020
- First submitted
- 30 Aug 2012
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Negreiros Cabral K, Perracini MR, Soares AT, de Cristo Stein F, Sera CT, Tiedemann A, Sherrington C, Filho WJ, Paschoal SM. Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: study protocol for a randomised controlled trial (Prevquedas Brazil). BMC Geriatr. 2013 Mar 15;13:27. doi: 10.1186/1471-2318-13-27.
PubMed 23497000
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multifactorial Falls Prevention Program in Community-dwelling Older People When Compared to Usual Care: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01698580
- Acronym / sponsor ID
- CAPPesq 0145/11
- Conditions
- Accidental Falls
- Keywords
- accidental falls, aged, aged, 80 and over, prevention and control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Universidade Cidade de Sao Paulo, University of Sao Paulo General Hospital, The George Institute
- Study start
- Dec 2013
- Primary completion
- Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | Active comparator | Other: Usual careThe 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. |
| Multifactorial Falls Prevention Program | Experimental | Other: On-site exercise, Other: home-based exercise, Other: Educational and behavioural, Other: Management of modifiable risk factors12 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community-dwelling older adults, men and women aged 60 and over who have fallen at least once in the last 12 months
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-site exerciseAlso: balance exercises, strengthening exercisesThe 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 | Multifactorial Falls Prevention Program |
| home-based exerciseAlso: balance exercises, strengthening exercisesParticipants 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 | Multifactorial Falls Prevention Program |
| Educational and behaviouralSessions 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 | Multifactorial Falls Prevention Program |
| Management of modifiable risk factorsPostural 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 | Multifactorial Falls Prevention Program |
| Usual careThe 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 |
Primary outcome
rate of falls
Time frame: 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
Time frame: 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.
6 secondary outcomes
Fall-related self-efficacy
Time frame: baseline, 6 months, 12 months
Balance: Berg Balance Scale, Alternate step test, sit to stand test
Time frame: baseline, 6 months and 12 months
Fall risk: Quick Falls Risk Assessment
Time frame: baseline, 6 months, 12 months
The level of difficulty with daily tasks
Time frame: baseline, 6 months, 12 months
Services use
Time frame: 6 months, 12 months
Strength: Grip Strength with a dynamometer
Time frame: Strength
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Derived from this study: PubMed 23497000de Negreiros Cabral K, Perracini MR, Soares AT, de Cristo Stein F, Sera CT, Tiedemann A, Sherrington C, Filho WJ, Paschoal SM. Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: study protocol for a randomised controlled trial (Prevquedas Brazil). BMC Geriatr. 2013 Mar 15;13:27. doi: 10.1186/1471-2318-13-27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica R Perracini, PT, PhD principal investigator
Universidade Cidade de Sao Paulo
Luiz Eugenio G Leme, MD, PhD study director
University of Sao Paulo
Sergio O Paschoal, MD, PhD study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-site exercise, home-based exercise and Educational and behavioural in people with Accidental Falls, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of falls (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.