Accidental FallsLIFTNCT01370174
Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging
A study testing Physical Training Interventions in people with Accidental Falls, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
Falls and their consequences are among the major problems in the medical care of older individuals. The long-term goal of this research is to establish the efficacy of a scientifically grounded and mechanism-based therapeutic intervention for improving balance function and preventing falls in older people. 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 Training Interventions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2012to 24 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 65 years of age or older
- Body Mass Index in range of 18.5 to 30
Who cannot join
- Timed -Up-and-Go faster than 12 seconds (very low fall risk)
- Persons advised by their doctor not to exercise
- Evidence of any medical condition as determined by physician or results of blood test that would lead to increased risk of accident, injury or illness due to any aspect of proposed tests and interventions, including resistance training
- Persons with history of brain, nerve or muscle disorder including Parkinson's disease, stroke, peripheral neuropathy or myopathy
- Persons with reported hip or knee joint replacement in past 6 months
- Persons with significant foot deformities or amputation as determined by a qualified medical professional
Show all 15Show fewer
- Persons with sedative medications including hypnotics, anxiolytic, opioids, neuroleptics, or sedating antidepressants
- Persons using medications that pose a significant bleeding risks as determined by a qualified medical professional
- Any significant functional limitation as determined by a score of zero on any of the six daily tasks of the Instrumental Activities of Daily Living Scale (IADL) that enable independent living in the community. The six functional items used are: A. Telephone, B. Shopping, C. Food Preparation, D. Housekeeping, E. Laundry, and F. Transportation
- Non-ambulatory (unable to walk)
- Persons using a gait device at all times in home environment
- Cognitive impairment defined as Mini-Mental State Exam score <24
- Persons with uncorrected vision limiting visual function or eye surgery in ast 6 months
- Persons with uncorrected hearing impairment limiting daily activities or communication as determined by a qualified medical professional
- Persons with major depression (Centers for Epidemiological Studies Depression Survey score >16)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PTRS Research Lab
Baltimore, Maryland, 21201
VA Maryland Health Care System
Baltimore, Maryland, 21201
About this study
Falls and their consequences are among the major problems in the medical care of older individuals. The long-term goal of this research is to establish the efficacy of a scientifically grounded and mechanism-based therapeutic intervention for improving balance function and preventing falls in older people. When human balance is challenged, protective stepping is a vital strategy for preventing a fall during activities of daily life. Many older people at risk for falls have particular difficulties with successfully stepping sideways as a protective response to loss of balance in the lateral direction. We propose that age-related declines in lateral balance function through impaired protective stepping that precipitates falls, result from neuromechanical (NM) limitations in hip abductor-adductor (AB-AD) muscle strength (torque and power). Moreover, we hypothesize that these functional and NM impairments are reversible with combined high intensity induced step training (IST) and muscle strengthening.
Read the detailed description
Falls and their consequences are among the major problems in the medical care of older individuals. Some 30 percent of community dwelling people aged 65 years and older, and over 50 percent of those living in institutions fall each year. Among older adults, complications of falls are the leading cause of deaths due to injury and are the most common cause of nonfatal injuries and hospitalization for trauma. The total lifetime healthcare cost of fall-related injuries for the elderly have been projected to reach $85 billion by the year 2020. Even in the absence of injury due to falling, the tendency to lose balance among the elderly commonly results in an overall reduction in the level of physical activity, and to a decreased ability to satisfactorily function in social roles.
Despite the contributions of multiple risk factors to age-related falls (e.g., environmental hazards, orthostatic hypotension, disorientation, sedation), it is well recognized that those who fall present greater impairments in neuromechanical (NM) factors than do older non-fallers. Aging changes in balance and gait associated with NM impairments have also been consistently found to be among the most important risk factors for falls. What is presently unresolved, however, is which among the age-associated NM impairments, altered balance and mobility functions are best associated with falls and responsive to interventions (training).
- Conditions
- Accidental Falls
- Being tested
- Physical Training Interventions
- Keywords
- Falls, Balance, Protective Stepping, Lateral Balance, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Training InterventionsOther
Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Induced Step Training (IST) | Active comparator | The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping. Receives: Other: Physical Training Interventions |
| Hip Strength Training (HST) | Active comparator | The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises. Receives: Other: Physical Training Interventions |
| Combined Induced Step and Hip Strength Training | Active comparator | This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST). Receives: Other: Physical Training Interventions |
| Standard Flexibility and Relaxation (SFR) | Placebo comparator | The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises. Receives: Other: Physical Training Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Abductor Torque
Hip abductor torque at baseline and 3 months
Measured: At baseline and post-test at 3 months
Step Count
The number of balance recovery steps at balance tolerance threshold at baseline and 3 months
Measured: At baseline and post-test at 3 months
Secondary outcomes (1)
Falls
Analysis of fall history between falls in the year prior to enrollment and 12 months after training finished.
Measured: Individual subject at 12 months post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study start25 Jan 2012
- Primary completion9 Dec 2016
- Study completion24 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, VA Maryland Health Care System
- Responsible party
- Principal investigator, Vicki Gray, University of Maryland, Baltimore
- Investigators
- Mark W Rogers, PT, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370174
- Sponsor's protocol ID
- HP-00045644
- Acronym
- LIFT
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2011
- Last updated
- 5 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging
- ClinicalTrials.gov ID
- NCT01370174
- Acronym / sponsor ID
- LIFT / HP-00045644
- Conditions
- Accidental Falls
- Keywords
- Falls, Balance, Protective Stepping, Lateral Balance, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Northwestern University, VA Maryland Health Care System
- Study start
- 25 Jan 2012 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Falls and their consequences are among the major problems in the medical care of older individuals. The long-term goal of this research is to establish the efficacy of a scientifically grounded and mechanism-based therapeutic intervention for improving balance function and preventing falls in older people. When human balance is challenged, protective stepping is a vital strategy for preventing a fall during activities of daily life. Many older people at risk for falls have particular difficulties with successfully stepping sideways as a protective response to loss of balance in the lateral direction. We propose that age-related declines in lateral balance function through impaired protective stepping that precipitates falls, result from neuromechanical (NM) limitations in hip abductor-adductor (AB-AD) muscle strength (torque and power). Moreover, we hypothesize that these functional and NM impairments are reversible with combined high intensity induced step training (IST) and muscle strengthening.
Detailed description
Falls and their consequences are among the major problems in the medical care of older individuals. Some 30 percent of community dwelling people aged 65 years and older, and over 50 percent of those living in institutions fall each year. Among older adults, complications of falls are the leading cause of deaths due to injury and are the most common cause of nonfatal injuries and hospitalization for trauma. The total lifetime healthcare cost of fall-related injuries for the elderly have been projected to reach $85 billion by the year 2020. Even in the absence of injury due to falling, the tendency to lose balance among the elderly commonly results in an overall reduction in the level of physical activity, and to a decreased ability to satisfactorily function in social roles.
Despite the contributions of multiple risk factors to age-related falls (e.g., environmental hazards, orthostatic hypotension, disorientation, sedation), it is well recognized that those who fall present greater impairments in neuromechanical (NM) factors than do older non-fallers. Aging changes in balance and gait associated with NM impairments have also been consistently found to be among the most important risk factors for falls. What is presently unresolved, however, is which among the age-associated NM impairments, altered balance and mobility functions are best associated with falls and responsive to interventions (training).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Induced Step Training (IST) | Active comparator | Other: Physical Training InterventionsThe IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping. |
| Hip Strength Training (HST) | Active comparator | Other: Physical Training InterventionsThe HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises. |
| Combined Induced Step and Hip Strength Training | Active comparator | Other: Physical Training InterventionsThis training group consists of combined induced step training (IST) and hip AB-AD strength training (HST). |
| Standard Flexibility and Relaxation (SFR) | Placebo comparator | Other: Physical Training InterventionsThe SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years of age or older
- Body Mass Index in range of 18.5 to 30
Key exclusion criteria (15 listed)
- Timed -Up-and-Go faster than 12 seconds (very low fall risk)
- Persons advised by their doctor not to exercise
- Evidence of any medical condition as determined by physician or results of blood test that would lead to increased risk of accident, injury or illness due to any aspect of proposed tests and interventions, including resistance training
- Persons with history of brain, nerve or muscle disorder including Parkinson's disease, stroke, peripheral neuropathy or myopathy
- Persons with reported hip or knee joint replacement in past 6 months
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 Training InterventionsSubjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. | Other | Combined Induced Step and Hip Strength Training, Hip Strength Training (HST), Induced Step Training (IST), Standard Flexibility and Relaxation (SFR) |
Primary outcome
Hip Abductor Torque
Time frame: At baseline and post-test at 3 months
Hip abductor torque at baseline and 3 months
Step Count
Time frame: At baseline and post-test at 3 months
The number of balance recovery steps at balance tolerance threshold at baseline and 3 months
1 secondary outcome
Falls
Time frame: Individual subject at 12 months post training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mark W Rogers, PT, PhD principal investigator
University of Maryland, Baltimore
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 Training Interventions in people with Accidental Falls, run by University of Maryland, Baltimore at 2 sites in United States.
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 2 inclusion and 15 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 5 Oct 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hip Abductor Torque (time frame: At baseline and post-test at 3 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?
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 5 Oct 2021.