NCT01698580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
612

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

6 years

First QC Date

August 30, 2012

Last Update Submit

April 13, 2020

Conditions

Accidental Falls

Keywords

accidental fallsagedaged, 80 and overprevention and control

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12 months

Secondary Outcomes (6)

  • 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

  • Fall risk: Quick Falls Risk Assessment

    baseline, 6 months, 12 months

  • The level of difficulty with daily tasks

    baseline, 6 months, 12 months

  • Services use

    6 months, 12 months

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: On-site exerciseOther: home-based exerciseOther: Educational and behaviouralOther: Management of modifiable risk factors

Interventions

On-site exerciseOTHER

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.

Also known as: balance exercises, strengthening exercises
Multifactorial Falls Prevention Program
home-based exerciseOTHER

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.

Also known as: balance exercises, strengthening exercises
Multifactorial Falls Prevention Program
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.

Multifactorial Falls Prevention Program
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.

Multifactorial Falls Prevention Program
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.

usual care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling older adults, men and women aged 60 and over who have fallen at least once in the last 12 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo - Orthopedics Institute

São Paulo, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 23497000DERIVED

Study Officials

  • Monica R Perracini, PT, PhD

    Universidade Cidade de Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Luiz Eugenio G Leme, MD, PhD

    University of Sao Paulo

    STUDY DIRECTOR

  • Sergio O Paschoal, MD, PhD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD Professor

Study Record Dates

First Submitted

August 30, 2012

First Posted

October 3, 2012

Study Start

December 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 20, 2019

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations

BR(1)