Lower Extremity Weakness DistalNCT01552551
Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program
A study testing Assessment and education, Healthy Steps with Falls Case Management and Healthy Steps in Motion in people with Lower Extremity Weakness Distal and Distorted; Balance, run by University of Pittsburgh at 1 site in United States.
Trial summary
Older adults at high risk of falls will complete the PA Healthy Steps program. This program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Lower Extremity Weakness Distal, Distorted; Balance
- What is being tested?
- Assessment and education, Healthy Steps with Falls Case Management and Healthy Steps in Motion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2013
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Willing to be randomized
- Scoring in the lowest tertile on at least one test in the Healthy Steps lower extremity performance battery
- Age 50+
Who cannot join
- Hospice enrollee or life-threatening illness
- Active cancer treatment
- Neurologic disease linked to falls risk, such as Parkinson's
- Unable to ambulate indoors
- High likelihood of moving in next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Older adults at high risk of falls will complete the PA Healthy Steps program. This program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. Participants will then be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which adherence to physician and home safety assessments will be facilitated; and (iii) Healthy Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All participants will be followed monthly for 6 months through personal and automated telephone interview protocols to ascertain falls and injuries.
Read the detailed description
This falls prevention program is offered in 11 senior housing sites. Trained instructors from the research team provide the Healthy Steps in Motion exercise classes. Participants provide a signed form indicating physician clearance for participation. Falls case management involves monthly calls to speak with participants about home safety checks, perceived risk for falls, and physician contact or other visits to health care professionals to reduce falls risk.
This study is a pilot. The research team is interested in participation and adherence, as well as the primary outcome of falls incidence.
- Being tested
- Assessment and education, Healthy Steps with Falls Case Management, Healthy Steps in Motion
- Keywords
- Falls, exercise, safety, injury, Older adults
- Medical subject headings
- Motor Activity, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment and educationBehavioural
PA Healthy Steps program
Healthy Steps with Falls Case ManagementBehavioural
Counseling to ensure that participants receive a physician assessment and home safety check
Healthy Steps in MotionBehavioural
Group exercise program
| Study group | Role | What they receive |
|---|---|---|
| Healthy Steps | Active comparator | Healthy Steps program as currently implemented by the PA Department of Aging Receives: Behavioral: Assessment and education |
| Healthy Steps with Falls Case Management | Experimental | Healthy Steps program augmented with research interventionist guidance on seeking physician care and home safety assessment Receives: Behavioral: Healthy Steps with Falls Case Management |
| Healthy Steps in Motion | Experimental | Healthy Steps program augmented with Healthy Steps in Motion, a 4-week, twice a week program of group exercise. Receives: Behavioral: Healthy Steps in Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls
Falls ascertained in automated monthly telephone contact
Measured: 6 months
Secondary outcomes (1)
Fall-related injuries requiring hospitalization/emergency department care
Events ascertained in a monthly automated telephone interview
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Weakness DistalStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Steven M. Albert, University of Pittsburgh
- Investigators
- Steven M Albert, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552551
- Sponsor's protocol ID
- U48DP002657-RCT
- Other IDs
- U48DP002657
- Status last verified
- Dec 2015
- First submitted
- 8 Mar 2012
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Deidentified research data will be made available to qualified investigators
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program
- ClinicalTrials.gov ID
- NCT01552551
- Acronym / sponsor ID
- U48DP002657-RCT
- Keywords
- Falls, exercise, safety, injury, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Mar 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.
Older adults at high risk of falls will complete the PA Healthy Steps program. This program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. Participants will then be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which adherence to physician and home safety assessments will be facilitated; and (iii) Healthy Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All participants will be followed monthly for 6 months through personal and automated telephone interview protocols to ascertain falls and injuries.
Detailed description
This falls prevention program is offered in 11 senior housing sites. Trained instructors from the research team provide the Healthy Steps in Motion exercise classes. Participants provide a signed form indicating physician clearance for participation. Falls case management involves monthly calls to speak with participants about home safety checks, perceived risk for falls, and physician contact or other visits to health care professionals to reduce falls risk.
This study is a pilot. The research team is interested in participation and adherence, as well as the primary outcome of falls incidence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Steps | Active comparator | Behavioral: Assessment and educationHealthy Steps program as currently implemented by the PA Department of Aging |
| Healthy Steps with Falls Case Management | Experimental | Behavioral: Healthy Steps with Falls Case ManagementHealthy Steps program augmented with research interventionist guidance on seeking physician care and home safety assessment |
| Healthy Steps in Motion | Experimental | Behavioral: Healthy Steps in MotionHealthy Steps program augmented with Healthy Steps in Motion, a 4-week, twice a week program of group exercise. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide informed consent
- Willing to be randomized
- Scoring in the lowest tertile on at least one test in the Healthy Steps lower extremity performance battery
- Age 50+
Key exclusion criteria (5 listed)
- Hospice enrollee or life-threatening illness
- Active cancer treatment
- Neurologic disease linked to falls risk, such as Parkinson's
- Unable to ambulate indoors
- High likelihood of moving in next 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 |
|---|---|---|
| Assessment and educationPA Healthy Steps program | Behavioural | Healthy Steps |
| Healthy Steps with Falls Case ManagementCounseling to ensure that participants receive a physician assessment and home safety check | Behavioural | Healthy Steps with Falls Case Management |
| Healthy Steps in MotionGroup exercise program | Behavioural | Healthy Steps in Motion |
Primary outcome
Falls
Time frame: 6 months
Falls ascertained in automated monthly telephone contact
1 secondary outcome
Fall-related injuries requiring hospitalization/emergency department care
Time frame: 6 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 30 Dec 2015.
- Individual participant dataSharing planned: Yes. Deidentified research data will be made available to qualified investigators
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.
Steven M Albert, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment and education, Healthy Steps with Falls Case Management and Healthy Steps in Motion in people with Lower Extremity Weakness Distal and Distorted; Balance, run by University of Pittsburgh at 1 site 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 4 inclusion and 5 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 30 Dec 2015. 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 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. 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?
Falls (time frame: 6 months). 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 30 Dec 2015.