Effectiveness of a Multifactorial Falls Prevention Program in Community-dwelling Older People When Compared to Usual Care: A Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 612
- Locations
- 1
- Primary Endpoint
- rate of falls
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Usual care (Other)
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.
Intervention: home-based exercise (Other)
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.
Intervention: Educational and behavioural (Other)
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.
Intervention: Management of modifiable risk factors (Other)
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.
Intervention: On-site exercise (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Fall risk: Quick Falls Risk Assessment(baseline, 6 months, 12 months)
- The level of difficulty with daily tasks(baseline, 6 months, 12 months)
- Strength: Grip Strength with a dynamometer(Strength)
- Fall-related self-efficacy(baseline, 6 months, 12 months)
- Balance: Berg Balance Scale, Alternate step test, sit to stand test(baseline, 6 months and 12 months)
- Services use(6 months, 12 months)
Investigators
Luiz Eugenio Garcez Leme
MD, PhD Professor
University of Sao Paulo