AgingNCT07513805
Implementation of Routine Walking Speed Measurements in Older Veterans
A study testing FASTER in people with Aging and Fall Risk, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Walking speed is a powerful predictor of mortality and adverse health consequences (e.g. fall or hospitalization) in older adults. Knowledge of individuals' walking speed can provide unique insight into current physical function and need for healthcare services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aging, Fall Risk, Mobility Limitation
- What is being tested?
- FASTER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Site Inclusion Criteria:
- VHA primary care clinics
- VHA Personnel Inclusion Criteria:
- Providers working in a VHA primary care clinic where FASTER is implemented
- Nursing staff working in a VHA primary care clinic where FASTER is implemented
- Veteran Inclusion Criteria:
- Veterans 60 years and older receiving care in a VHA primary care clinic where FASTER is implemented
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Jennifer E Stevens-Lapsley, PhD, 303-949-9304, Jennifer.Stevens-Lapsley@va.gov
Joyce A Middleton, (303) 908-8935, joyce.middleton@va.gov
About this study
Official title: Walking Speed as a Vital Sign: Enhancing Function in Older Veterans
Walking speed is a powerful predictor of mortality and adverse health consequences (e.g. fall or hospitalization) in older adults. Knowledge of individuals' walking speed can provide unique insight into current physical function and need for healthcare services. Furthermore, walking speed is a modifiable risk factor such that early recognition of physical function decline allows for appropriate and timely intervention prior to the occurrence of adverse health events. Therefore, this proposal seeks to implement routine measures of walking speed into VHA primary care as a 'vital sign' to routinely monitor Veteran physical function and help guide provider referrals.
Read the detailed description
Background: Walking speed is a vital sign that can predict mortality and adverse health outcomes in older adults. However, it is not routinely assessed in outpatient primary care clinics, potentially leading to missed opportunities for timely intervention and rehabilitative care. Current literature identifies walking speed as a sensitive measure of overall health and functional status, with a walking speed of <0.6 m/s indicating increased risk of adverse events and reduced independence. Consequently, knowledge of individuals' walking speed can provide unique insight into current physical function and need for healthcare services. Importantly, walking speed is also a modifiable risk factor and is sensitive to change in multiple populations with varying medical conditions, making it an ideal measure for longitudinal monitoring of physical function. The investigators' preliminary work implementing walking speed measurement into outpatient geriatric clinical care, along with recent literature, demonstrates that routine walking speed assessments are feasible, quick, and safe.
Significance: Current VHA standard of care within primary care clinics relies on subjective information to evaluate a Veteran's physical function, which can be unreliable and inaccurate. Implementation of walking speed will introduce an objective measure that can accurately assess how a Veteran's physical function changes over time, thus helping providers identify whether referrals to rehabilitation services are needed.
Innovation and Impact: This proposal is innovative as it will be one of the first studies to assess the implementation and effect of walking speed across multiple primary care clinics. Additionally, examination of contextual factors influencing the implementation and effect of walking speed is innovative and will lead to adaptations that facilitate future widespread implementation.
Methodology: Pragmatic hybrid type 2 effectiveness-implementation study using a stepped-wedge cluster randomized trial design to evaluate and improve walking speed implementation and assess its effectiveness across VHA PACT clinics.
- Conditions
- Aging, Fall Risk, Mobility Limitation
- Being tested
- Usual Care, FASTER
- Keywords
- Screening, Preventative Care, Implementation Science, RE-AIM, PRISM
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
During the Usual Care phase, participating clinics will continue with usual care with the addition that walking speed will be measured and recorded. Veterans and providers will be blinded to walking speed measurement so as to not influence care.
FASTEROther
During the FASTER phase, walking speed will be measured during clinic visits, recorded in the medical record, and used by providers to guide care. An Action Toolkit will be provided with resources for providers to support informed care decisions based on Veterans' walking speeds.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Usual care will continue in clinical practice with this phase occurring before FASTER implementation. Receives: Other: Usual Care |
| FASTER | Experimental | The FASTER intervention includes measurement, recording, and use of walking speed measurement to help guide care in older Veterans. Receives: Other: FASTER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed
Time to complete 4-meter walk at usual speed converted to meters per second. Higher speed indicates better function.
Measured: Change in walking speed before exposure and change in walking speed after exposure to FASTER intervention (up to 12 months).
Secondary outcomes (2)
Adverse Events (Injurious Falls)
Falls that result in a medical visit
Measured: Start of usual care to end of implementation (anticipated 24 months).
Adverse Events (Emergency Department Visits and Hospitalizations)
Emergency department visits and hospitalizations
Measured: Start of usual care to end of implementation (anticipated 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Apr 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The FASTER intervention includes three stages. First, the Veteran is instructed to walk over a 6-meter course (4-meter timed course with 1-meter acceleration and deceleration zones) with an emphasis on walking at their usual pace. While the Veteran walks this course, a stopwatch is used to measure walking speed. Second, the walking speed is input into the medical record along with any assistive device used during measurement. Third, providers use the walking speed information to help guide care and potential referrals.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer E. Stevens-Lapsley, PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513805
- Sponsor's protocol ID
- HSR6-009-24S
- Other IDs
- I01HX003877
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team intends to share study data that may be requested from other research investigators in a data-sharing agreement provided at the study end. Data prepared for distribution under a data-sharing agreement will be further redacted to ensure privacy of study participant identity yet allow analyses to occur by other investigators. The data-sharing agreement will include requirements to protect participants' privacy and data confidentiality. All participants will be de-identified using a coded participant ID to maintain confidentiality and will not be individually identifiable by name.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Speed as a Vital Sign: Enhancing Function in Older Veterans
- ClinicalTrials.gov ID
- NCT07513805
- Acronym / sponsor ID
- HSR6-009-24S
- Conditions
- Aging, Fall Risk, Mobility Limitation
- Keywords
- Screening, Preventative Care, Implementation Science, RE-AIM, PRISM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,500 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 7 Apr 2026 (actual)
- 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.
Walking speed is a powerful predictor of mortality and adverse health consequences (e.g. fall or hospitalization) in older adults. Knowledge of individuals' walking speed can provide unique insight into current physical function and need for healthcare services. Furthermore, walking speed is a modifiable risk factor such that early recognition of physical function decline allows for appropriate and timely intervention prior to the occurrence of adverse health events. Therefore, this proposal seeks to implement routine measures of walking speed into VHA primary care as a 'vital sign' to routinely monitor Veteran physical function and help guide provider referrals.
Detailed description
Background: Walking speed is a vital sign that can predict mortality and adverse health outcomes in older adults. However, it is not routinely assessed in outpatient primary care clinics, potentially leading to missed opportunities for timely intervention and rehabilitative care. Current literature identifies walking speed as a sensitive measure of overall health and functional status, with a walking speed of <0.6 m/s indicating increased risk of adverse events and reduced independence. Consequently, knowledge of individuals' walking speed can provide unique insight into current physical function and need for healthcare services. Importantly, walking speed is also a modifiable risk factor and is sensitive to change in multiple populations with varying medical conditions, making it an ideal measure for longitudinal monitoring of physical function. The investigators' preliminary work implementing walking speed measurement into outpatient geriatric clinical care, along with recent literature, demonstrates that routine walking speed assessments are feasible, quick, and safe.
Significance: Current VHA standard of care within primary care clinics relies on subjective information to evaluate a Veteran's physical function, which can be unreliable and inaccurate. Implementation of walking speed will introduce an objective measure that can accurately assess how a Veteran's physical function changes over time, thus helping providers identify whether referrals to rehabilitation services are needed.
Innovation and Impact: This proposal is innovative as it will be one of the first studies to assess the implementation and effect of walking speed across multiple primary care clinics. Additionally, examination of contextual factors influencing the implementation and effect of walking speed is innovative and will lead to adaptations that facilitate future widespread implementation.
Methodology: Pragmatic hybrid type 2 effectiveness-implementation study using a stepped-wedge cluster randomized trial design to evaluate and improve walking speed implementation and assess its effectiveness across VHA PACT clinics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The FASTER intervention includes three stages. First, the Veteran is instructed to walk over a 6-meter course (4-meter timed course with 1-meter acceleration and deceleration zones) with an emphasis on walking at their usual pace. While the Veteran walks this course, a stopwatch is used to measure walking speed. Second, the walking speed is input into the medical record along with any assistive device used during measurement. Third, providers use the walking speed information to help guide care and potential referrals.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareUsual care will continue in clinical practice with this phase occurring before FASTER implementation. |
| FASTER | Experimental | Other: FASTERThe FASTER intervention includes measurement, recording, and use of walking speed measurement to help guide care in older Veterans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- VHA primary care clinics
- Providers working in a VHA primary care clinic where FASTER is implemented
- Nursing staff working in a VHA primary care clinic where FASTER is implemented
- Veterans 60 years and older receiving care in a VHA primary care clinic where FASTER is implemented
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Usual CareDuring the Usual Care phase, participating clinics will continue with usual care with the addition that walking speed will be measured and recorded. Veterans and providers will be blinded to walking speed measurement so as to not influence care. | Other | Usual Care |
| FASTERDuring the FASTER phase, walking speed will be measured during clinic visits, recorded in the medical record, and used by providers to guide care. An Action Toolkit will be provided with resources for providers to support informed care decisions based on Veterans' walking speeds. | Other | FASTER |
Primary outcome
Walking Speed
Time frame: Change in walking speed before exposure and change in walking speed after exposure to FASTER intervention (up to 12 months).
Time to complete 4-meter walk at usual speed converted to meters per second. Higher speed indicates better function.
2 secondary outcomes
Adverse Events (Injurious Falls)
Time frame: Start of usual care to end of implementation (anticipated 24 months).
Adverse Events (Emergency Department Visits and Hospitalizations)
Time frame: Start of usual care to end of implementation (anticipated 24 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. The research team intends to share study data that may be requested from other research investigators in a data-sharing agreement provided at the study end. Data prepared for distribution under a data-sharing agreement will be further redacted to ensure privacy of study participant identity yet allow analyses to occur by other investigators. The data-sharing agreement will include requirements to protect participants' privacy and data confidentiality. All participants will be de-identified using a coded participant ID to maintain confidentiality and will not be individually identifiable by name.
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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.
Jennifer E. Stevens-Lapsley, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FASTER in people with Aging and Fall Risk, run by VA Office of Research and Development 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 7 inclusion and 1 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: opening soon, as of the sponsor's last update on 7 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer E Stevens-Lapsley, PhD ((303) 949-9304, Jennifer.Stevens-Lapsley@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed (time frame: Change in walking speed before exposure and change in walking speed after exposure to FASTER intervention (up to 12 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 7 Apr 2026.