Accidental FallsNCT01713543
Community-based Falls Prevention Program for the Elderly
A study testing physical therapy in people with Accidental Falls, run by National University of Singapore at 2 sites in Singapore.
Trial summary
Background: Falls are the leading cause of injury among older adults in Singapore, but falls among the elderly can be preventable and the risks are predictable. Translating this understanding of falls etiology into an integrated clinical and public health program that is accessible to the elderly is a critical health… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 2 sitesSingapore
- Study dates
- Dec 2012to Apr 2015
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years
- Seen in the Emergency Department for a fall or injury related to a fall
- Able to follow 3 step commands
- Singapore citizen or Permanent Resident
- Living at home upon discharge
- Provision of informed consent
- If admitted to the hospital, the illness or disability is one from which they are expected to recover basic ADLs or weight bearing of the lower extremity within the next month
Who cannot join
- Those patients with severe physical and/or mental impairments which preclude participation in a program of physical therapy (as determined by a primary physician) will NOT be eligible for participation.
- Unable to participate in the exercise program due to conflicting schedules (e.g. full-time employment, on dialysis)
- Serious life limiting illness
- Patients seen at ED due to road traffic accidents
- Unable to walk even with assistance
- Not community dwelling prior to ED visit
- Total blindness
- Needs emergency inpatient surgery and, if admitted to the hospital, the illness or disability is one from which they are not expected to recover basic ADLs or weight bearing in the lower extremity within the next one month.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital
Singapore, 169608
Changi General Hospital
Singapore, 529889
About this study
Official title: Multifactorial, Evidence-based Program of Screening, Risk Modification and Physical Therapy to Prevent Falls Among Vulnerable Elderly Recently Discharged From Hospital to the Community.
Background: Falls are the leading cause of injury among older adults in Singapore, but falls among the elderly can be preventable and the risks are predictable. Translating this understanding of falls etiology into an integrated clinical and public health program that is accessible to the elderly is a critical health services delivery challenge.
Hypothesis: An evidence-based program of screening, risk modification and physical therapy delivered in a community setting will reduce recurrent falls incidence among a high-risk group of elderly recently discharged to the community.
Methodology: This randomized controlled trial targets patients seen at Emergency Department (ED) for a fall or fall-related injuries who are at least 65 years old and will be discharged to home. Upon signing the informed consent form, the participants will be followed up for nine months from the baseline assessment during which the participants are randomized into either a control or the intervention group. The participants in the intervention group will be provided with a multifactorial program of screening, risk modification and physical therapy focused on progressive strength, balance, and gait training either as an individualized program or a group setting in the community for the first three months from the date of randomization. The number of recurrent falls will be monitored via a falls prevention diary maintained by (or for) each participant.
Read the detailed description
Objective:
To develop and demonstrate the feasibility and effectiveness of a multifactorial, community-based falls prevention program of screening, risk modification, and progressive physical therapy that targets vulnerable elderly Singaporeans at high-risk of falls.
Methodology:
This two-year, multi-center, two-arm, parallel group, randomized controlled trial will be divided into three phases: (1) pre-study, (2) intervention, and (3) analysis.
During the pre-study phase, overseas experts will train local physiotherapists and community health workers on how to administer and deliver the falls prevention program. Engaging hospital-based physiotherapists to deliver the home-based assessments and exercise programs will maximize the likelihood of long-term sustainability of the intervention program. In addition, manuals will be developed for physiotherapists to guide the evaluation risk factor assessments, home environment assessments, appropriate referrals to different health care providers, and selection of exercise programs that will be progressive, challenging and of optimal intensity and durations. Manuals for risk factor assessments will be shared with the blinded assessors.
The intervention phase will be divided into two phases: a three-month "Active Intervention Phase" and a six-month "Maintenance Phase." In the beginning of the active intervention phase, the participants in the intervention group will receive a detailed falls risk assessment at the baseline assessment by a physiotherapist. The risk factors that will be assessed are the following:
- Poor vision: Referral to ophthalmologist for correction
- Polypharmacy: Referral to AIC for management of medications if use of five or more medications
- Environmental Hazards: Caregiver education and suitable recommendations according to the CDC guidelines to modify risk such as removal of rugs, change to safer footwear, use of non-slip bath mats, additional lighting at night.
- Deficiencies in gait, balance or mobility: Physiotherapist-supervised program of gait training, balance and strengthening exercises In the analysis phase, the collected data will be analyzed. The primary outcome measure of the study is the number of fallers over the entire study period. The number of falls will be captured by a falls prevention diary maintained by (or for) each participant.
Procedures:
The elderly seen at ED for a fall or fall-related injury will be screened for participation of the study. Once the consent is taken, all study participants will be given an assessment by a physiotherapist at baseline which assesses sociodemographic characteristics, functional status measured by the Short Physical Performance Battery (SPPB), two-minute walk test, history of falls, cognitive impairment measured by the Montreal Cognitive Assessment (MoCA), quality of life (EQ-5D-5L and EQ-VAS), health care utilization, and medical history (polypharmacy, orthostatic vital signs, and self-reporting eyesight and hearing).
At the end of baseline assessment, the participants will be assigned either a control or the intervention group. Before the start of the exercise sessions, the participants in the intervention group will. Need to complete Physical Activity Readiness Questionnaire (PAR-Q) and a medical evaluation by a physician to ensure that the participants are fit for physical activity. Based on the SPPB score at baseline assessment, participants will be categorized as either high-risk (SPPB<6) or low-to-moderate-risk (SPPB>6) for falls. High-risk patients will be given an individualized PT-supervised program of physical therapy that specifically targets impairments that interfere with engaging in exercise in group setting. The goal of the tailored physical therapy sessions is to modify impairments and transition these patients to an evidence-based exercise program. Low-to-moderate-risk patients will be directly enrolled into an evidence-based group exercise program. The group exercise programs will be offered as one-hour sessions, twice weekly over the intervention period. At the end of the active intervention phase, these participants will transition to a maintenance phase in which they will be encouraged to continue with the exercise on their own and will also be referred to the Health Promotion Board's STEP program.
The participants will be asked at the end of the active intervention phase (three months from the date of randomization) and at the end of the study period (nine months from the date of randomization) about their functional status, history of falls, cognitive impairment, quality of life, health care utilization, and medical history by the blinded assessors. Recurrent falls incidence will be monitored by participants' self-reporting monthly falls diary as well as monthly phone calls conducted by the study coordinator during the entire study period.
- Conditions
- Accidental Falls
- Being tested
- physical therapy
- Keywords
- falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyOther
Also called Falls Prevention
Tailored physical therapy sessions to modify impairments in balance and/or gait and to transition high-risk participants to an evidence-based group exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention consists of a tailored physical therapy focused on progressive strength, balance and gait training for a period of 3 months. Receives: Other: physical therapy |
| Control Group | No intervention | Usual care by physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of fallers who have fallen at least once during the 9-month study period
Measured: 9 months
Secondary outcomes (1)
The number of injurious falls and healthcare utilization
Injurious falls are the falls that resulted in participants' seeking medical attention or restricting their daily activities for at least 48 hours.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore, Duke-NUS Graduate Medical School, Singapore General Hospital, Changi General Hospital, Health Promotion Board, Singapore, Agency for Integrated Care, Singapore, Jurong Health Services
- Responsible party
- Principal investigator, Dr. David Matchar, National University of Singapore
- Investigators
- David B Matchar, MD, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713543
- Sponsor's protocol ID
- HSRG10MAY002
- Status last verified
- Sep 2015
- First submitted
- 22 Oct 2012
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39.
PubMed 17996052Matchar DB, Eom K, Duncan PW, Lee M, Sim R, Sivapragasam NR, Lien CT, Ong MEH. A Cost-Effectiveness Analysis of a Randomized Control Trial of a Tailored, Multifactorial Program to Prevent Falls Among the Community-Dwelling Elderly. Arch Phys Med Rehabil. 2019 Jan;100(1):1-8. doi: 10.1016/j.apmr.2018.07.434. Epub 2018 Aug 27.
PubMed 30165053Pua YH, Ong PH, Clark RA, Matcher DB, Lim EC. Falls efficacy, postural balance, and risk for falls in older adults with falls-related emergency department visits: prospective cohort study. BMC Geriatr. 2017 Dec 21;17(1):291. doi: 10.1186/s12877-017-0682-2.
PubMed 29268720Matchar DB, Duncan PW, Lien CT, Ong MEH, Lee M, Gao F, Sim R, Eom K. Randomized Controlled Trial of Screening, Risk Modification, and Physical Therapy to Prevent Falls Among the Elderly Recently Discharged From the Emergency Department to the Community: The Steps to Avoid Falls in the Elderly Study. Arch Phys Med Rehabil. 2017 Jun;98(6):1086-1096. doi: 10.1016/j.apmr.2017.01.014. Epub 2017 Feb 12.
PubMed 28202383
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial, Evidence-based Program of Screening, Risk Modification and Physical Therapy to Prevent Falls Among Vulnerable Elderly Recently Discharged From Hospital to the Community.
- ClinicalTrials.gov ID
- NCT01713543
- Acronym / sponsor ID
- HSRG10MAY002
- Conditions
- Accidental Falls
- Keywords
- falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore, Duke-NUS Graduate Medical School, Singapore General Hospital, Changi General Hospital, Health Promotion Board, Singapore, Agency for Integrated Care, Singapore, Jurong Health Services
- Study start
- Dec 2012
- Primary completion
- Apr 2015 (actual)
- First posted
- 24 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.
Background: Falls are the leading cause of injury among older adults in Singapore, but falls among the elderly can be preventable and the risks are predictable. Translating this understanding of falls etiology into an integrated clinical and public health program that is accessible to the elderly is a critical health services delivery challenge.
Hypothesis: An evidence-based program of screening, risk modification and physical therapy delivered in a community setting will reduce recurrent falls incidence among a high-risk group of elderly recently discharged to the community.
Methodology: This randomized controlled trial targets patients seen at Emergency Department (ED) for a fall or fall-related injuries who are at least 65 years old and will be discharged to home. Upon signing the informed consent form, the participants will be followed up for nine months from the baseline assessment during which the participants are randomized into either a control or the intervention group. The participants in the intervention group will be provided with a multifactorial program of screening, risk modification and physical therapy focused on progressive strength, balance, and gait training either as an individualized program or a group setting in the community for the first three months from the date of randomization. The number of recurrent falls will be monitored via a falls prevention diary maintained by (or for) each participant.
Detailed description
Objective:
To develop and demonstrate the feasibility and effectiveness of a multifactorial, community-based falls prevention program of screening, risk modification, and progressive physical therapy that targets vulnerable elderly Singaporeans at high-risk of falls.
Methodology:
This two-year, multi-center, two-arm, parallel group, randomized controlled trial will be divided into three phases: (1) pre-study, (2) intervention, and (3) analysis.
During the pre-study phase, overseas experts will train local physiotherapists and community health workers on how to administer and deliver the falls prevention program. Engaging hospital-based physiotherapists to deliver the home-based assessments and exercise programs will maximize the likelihood of long-term sustainability of the intervention program. In addition, manuals will be developed for physiotherapists to guide the evaluation risk factor assessments, home environment assessments, appropriate referrals to different health care providers, and selection of exercise programs that will be progressive, challenging and of optimal intensity and durations. Manuals for risk factor assessments will be shared with the blinded assessors.
The intervention phase will be divided into two phases: a three-month "Active Intervention Phase" and a six-month "Maintenance Phase." In the beginning of the active intervention phase, the participants in the intervention group will receive a detailed falls risk assessment at the baseline assessment by a physiotherapist. The risk factors that will be assessed are the following:
- Poor vision: Referral to ophthalmologist for correction
- Polypharmacy: Referral to AIC for management of medications if use of five or more medications
- Environmental Hazards: Caregiver education and suitable recommendations according to the CDC guidelines to modify risk such as removal of rugs, change to safer footwear, use of non-slip bath mats, additional lighting at night.
- Deficiencies in gait, balance or mobility: Physiotherapist-supervised program of gait training, balance and strengthening exercises In the analysis phase, the collected data will be analyzed. The primary outcome measure of the study is the number of fallers over the entire study period. The number of falls will be captured by a falls prevention diary maintained by (or for) each participant.
Procedures:
The elderly seen at ED for a fall or fall-related injury will be screened for participation of the study. Once the consent is taken, all study participants will be given an assessment by a physiotherapist at baseline which assesses sociodemographic characteristics, functional status measured by the Short Physical Performance Battery (SPPB), two-minute walk test, history of falls, cognitive impairment measured by the Montreal Cognitive Assessment (MoCA), quality of life (EQ-5D-5L and EQ-VAS), health care utilization, and medical history (polypharmacy, orthostatic vital signs, and self-reporting eyesight and hearing).
At the end of baseline assessment, the participants will be assigned either a control or the intervention group. Before the start of the exercise sessions, the participants in the intervention group will. Need to complete Physical Activity Readiness Questionnaire (PAR-Q) and a medical evaluation by a physician to ensure that the participants are fit for physical activity. Based on the SPPB score at baseline assessment, participants will be categorized as either high-risk (SPPB<6) or low-to-moderate-risk (SPPB>6) for falls. High-risk patients will be given an individualized PT-supervised program of physical therapy that specifically targets impairments that interfere with engaging in exercise in group setting. The goal of the tailored physical therapy sessions is to modify impairments and transition these patients to an evidence-based exercise program. Low-to-moderate-risk patients will be directly enrolled into an evidence-based group exercise program. The group exercise programs will be offered as one-hour sessions, twice weekly over the intervention period. At the end of the active intervention phase, these participants will transition to a maintenance phase in which they will be encouraged to continue with the exercise on their own and will also be referred to the Health Promotion Board's STEP program.
The participants will be asked at the end of the active intervention phase (three months from the date of randomization) and at the end of the study period (nine months from the date of randomization) about their functional status, history of falls, cognitive impairment, quality of life, health care utilization, and medical history by the blinded assessors. Recurrent falls incidence will be monitored by participants' self-reporting monthly falls diary as well as monthly phone calls conducted by the study coordinator during the entire study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: physical therapyThe intervention consists of a tailored physical therapy focused on progressive strength, balance and gait training for a period of 3 months. |
| Control Group | No intervention | –Usual care by physician. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age ≥ 65 years
- Seen in the Emergency Department for a fall or injury related to a fall
- Able to follow 3 step commands
- Singapore citizen or Permanent Resident
- Living at home upon discharge
Key exclusion criteria (8 listed)
- Those patients with severe physical and/or mental impairments which preclude participation in a program of physical therapy (as determined by a primary physician) will NOT be eligible for participation.
- Unable to participate in the exercise program due to conflicting schedules (e.g. full-time employment, on dialysis)
- Serious life limiting illness
- Patients seen at ED due to road traffic accidents
- Unable to walk even with assistance
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 |
|---|---|---|
| physical therapyAlso: Falls PreventionTailored physical therapy sessions to modify impairments in balance and/or gait and to transition high-risk participants to an evidence-based group exercise program. | Other | Intervention Group |
Primary outcome
The number of fallers who have fallen at least once during the 9-month study period
Time frame: 9 months
1 secondary outcome
The number of injurious falls and healthcare utilization
Time frame: 9 months
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 7 Sep 2015.
- Background: PubMed 17996052Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39.
- Derived from this study: PubMed 30165053Matchar DB, Eom K, Duncan PW, Lee M, Sim R, Sivapragasam NR, Lien CT, Ong MEH. A Cost-Effectiveness Analysis of a Randomized Control Trial of a Tailored, Multifactorial Program to Prevent Falls Among the Community-Dwelling Elderly. Arch Phys Med Rehabil. 2019 Jan;100(1):1-8. doi: 10.1016/j.apmr.2018.07.434. Epub 2018 Aug 27.
- Derived from this study: PubMed 29268720Pua YH, Ong PH, Clark RA, Matcher DB, Lim EC. Falls efficacy, postural balance, and risk for falls in older adults with falls-related emergency department visits: prospective cohort study. BMC Geriatr. 2017 Dec 21;17(1):291. doi: 10.1186/s12877-017-0682-2.
- Derived from this study: PubMed 28202383Matchar DB, Duncan PW, Lien CT, Ong MEH, Lee M, Gao F, Sim R, Eom K. Randomized Controlled Trial of Screening, Risk Modification, and Physical Therapy to Prevent Falls Among the Elderly Recently Discharged From the Emergency Department to the Community: The Steps to Avoid Falls in the Elderly Study. Arch Phys Med Rehabil. 2017 Jun;98(6):1086-1096. doi: 10.1016/j.apmr.2017.01.014. Epub 2017 Feb 12.
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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.
David B Matchar, MD principal investigator
Duke-NUS Graduate Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy in people with Accidental Falls, run by National University of Singapore at 2 sites in Singapore.
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 7 inclusion and 8 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 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
The number of fallers who have fallen at least once during the 9-month study period (time frame: 9 months). 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 NCT01713543, which also lists 4 linked publications.
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 7 Sep 2015.