AgingNCT07872384
Supplemental Mobility
A study testing High Intensity Rehabilitation and Safe Transfers and Mobility Program in people with Aging and Functional Recovery, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
This pilot study will evaluate the feasibility of a supplemental mobility intervention, the Safe Transfers And Mobility Program (STAMP). This program will be implemented in patients admitted to skilled nursing facilities (SNFs) following hospitalization. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aging, Functional Recovery, Skilled Nursing Facility
- What is being tested?
- High Intensity Rehabilitation and Safe Transfers and Mobility Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to May 2028
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 50 years old
- Admitted to SNF from the hospital
- Ambulatory at admission with minimal assistance or less
Who cannot join
- Contraindications to high-intensity resistance training (per American College of Sports Medicine Exercise Testing and Prescription)
- Neurological diagnosis (e.g., cerebral vascular accident, multiple sclerosis, Parkinson's disease, traumatic brain injury)
- Lower extremity weight-bearing precautions that require greater than minimal assistance with ambulation
- Subsequent SNF admission
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, 80045
Jennifer Stevens-Lapsley, PT, PhD, 303-724-9590, jennifer.stevens-lapsley@cuanschutz.edu
Aegis Therapies
Frisco, Texas, 75034
Dawn Greaves, 317-513-9116, Dawn.Greaves@aegistherapies.com
About this study
Official title: Improving Functional Recovery in Skilled Nursing Facilities Through Supplemental Mobility
This pilot study will evaluate the feasibility of a supplemental mobility intervention, the Safe Transfers And Mobility Program (STAMP). This program will be implemented in patients admitted to skilled nursing facilities (SNFs) following hospitalization. STAMP will be administered by a mobility aide who will support patients in increasing physical activity through walking and transfers outside of structured rehabilitation. Participants will either receive high-intensity rehabilitation (HIR) or usual care rehabilitation, combined with STAMP. The two main aims are: 1) determine the feasibility, acceptability, and safety of STAMP, and 2) evaluate the feasibility and variability of patient physical function outcome measures. The study will provide preliminary data on program delivery and safety to inform the design of a larger trial aimed at identifying the most effective strategies to optimize functional recovery in SNFs.
Read the detailed description
A substantial portion of older adults receiving care in skilled nursing facilities (SNFs) do not achieve successful outcomes, with nearly 40% unable to return home and up to 29% experiencing hospital readmission an outcome strongly associated with mortality. A major, modifiable contributor to these poor outcomes is reduced physical function. Although SNFs offer structured rehabilitation to address mobility impairments, its effectiveness is undermined by pervasive sedentary behavior. Up to 96% of patients receiving care in SNFs require assistance with mobility, and despite participating in daily rehabilitation, patients average less than 1,000 steps per day.
Our team conducted an NIH-funded pragmatic cluster randomized trial (R01, AG072693) evaluating high-intensity rehabilitation (HIR) to improve functional recovery. This trial provided a strong foundation and highlighted that high-intensity rehabilitation alone may be insufficient if patients remain inactive outside of scheduled sessions.
The purpose of this study is to determine the feasibility of an interdisciplinary, patient-centered mobility program (STAMP) to address common barriers in SNFs (e.g., staff shortages, safety concerns, limited training) and increase daily activity with support from a mobility aide. This aide will support patients in walking and functional transfers outside of formal therapy sessions, targeting 45 minutes of additional physical activity to complement structured rehabilitation. This study will explore whether STAMP alone or in combination with HIR offers a scalable strategy to improve function. The study will evaluate STAMP implemented in two settings: one with HIR + STAMP and one with usual care + STAMP. Investigators will determine feasibility, acceptability, and safety of STAMP through a convergent parallel mixed methods approach. Secondarily, investigators will evaluate the feasibility and variability of patient physical function outcome measures to inform outcome selection for future trials.
- Being tested
- High Intensity Rehabilitation, Safe Transfers and Mobility Program, Usual Care
- Keywords
- Rehabilitation, Older Adults, Physical Therapy, Occupational Therapy, i-STRONGER, High-Intensity Rehabilitation, Post-Acute Care, Physical Function, Safe Transfers and Mobility Program, Feasibility, Implementation Science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity RehabilitationOther
An 8RM is the dose necessary for most effective strength gains in community-dwelling older adults, and is equivalent to 80% of a one repetition max, which is the maximal load needed to voluntarily complete one repetition of a given exercise with proper form. Activities will include strength training, transfer practice, balance training, advanced ADLs. Clinicians will tailor the intervention for each activity to target overload using 8-repetition maximum for resistance training. Other interventions will be performed to muscle failure or inability to complete the final repetition. Failure is the inability to complete a repetition through the full, available range of motion without significant compensation. Further, high-intensity dosing requires continuous, volitional effort from the patient; therefore, incorporation of motivational interviewing strategies across sessions will maximize patient effort and self-efficacy.
Safe Transfers and Mobility ProgramOther
The Safe Transfers and Mobility Program (STAMP) embeds a mobility aide into daily care. STAMP is a patient-centered, scalable approach to extend the benefits of rehabilitation sessions by increasing mobility throughout the day and reinforcing activity between therapy sessions. Core components are: (1) targeting 45 minutes of additional daily physical activity through support with walking and functional mobility tasks; (2) establishing individualized mobility goals collaboratively set by the therapist and patient, based on functional level; (3) delivering progressive activities with walking distances increased by ~30% weekly, adjusted for patient tolerance; and (4) interdisciplinary coordination to incorporate STAMP sessions into routine care with minimal disruption to clinical workflow. Prior work suggests that 45 minutes of STAMP can at least double daily step counts, and increasing walking distance by 30% per week is feasible even for individuals with low baseline function.
Usual CareOther
Usual Care SNFs will continue with routine collection and documentation of physical performance outcomes (gait speed, SPPB, Modified Barthel ADL Index) as standard practice. Importantly, the Usual Care SNF including the facility, rehabilitation clinicians, and patients will not have access to i-STRONGER materials.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Not described Receives: Other: Usual Care |
| High Intensity Rehabilitation | Experimental | Not described Receives: Other: High Intensity Rehabilitation |
| Usual Care and STAMP | Experimental | Not described Receives: Other: Safe Transfers and Mobility Program; Other: Usual Care |
| High Intensity Rehabilitation and STAMP | Experimental | Not described Receives: Other: High Intensity Rehabilitation; Other: Safe Transfers and Mobility Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usual Gait Speed
Gait speed will be measured in meters/second using the time it takes to walk a 4-meter path at usual speed using a stopwatch. Completion rates will be collected. Within site pre- to post- STAMP changes will be assessed. Higher gait speed indicates better outcome.
Measured: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Secondary outcomes (11)
Feasibility of Intervention Measure (FIM)
Feasibility of Intervention (FIM) will be collected from SNF Providers to assess feasibility. The FIM is a 4-item survey rated on a 5-point Likert scale (1=completely disagree to 5=completely agree), with higher average scores indicating greater feasibility.
Measured: At end of STAMP phase, approximately 8 months
STAMP Session Adherence Rate
Of all enrolled patients, percent completing ≥ 80% of sessions attempted by mobility aide
Measured: Beginning of STAMP phase to end of STAMP phase, approximately 8 months
Modified 30 Second Sit to Stand
The Modified 30 second sit to stand test (m30STS) counts the number of stands from a chair completed in 30 seconds, which allows for upper extremity use on the armrests of a chair. The score is the total number of stands completed in 30 seconds; more than halfway up at the end of 30 seconds counts as a stand. Completion rates will be collected. Within site pre- to post- STAMP changes will be assessed. Higher scores indicate better outcomes.
Measured: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Number of Rehospitalizations
Number of re-hospitalizations during SNF stay.
Measured: Up to 8 months of Pre-STAMP phase and 8 months of STAMP phase
STAMP Intervention Fidelity
Percent of mobility aides achieving an average of ≥80% fidelity across study assessments. A formally trained site champion or research team member will measure STAMP fidelity on at least 2 patients per mobility aide each quarter.
Measured: Beginning of STAMP phase to end of STAMP phase, approximately 8 months
Theoretical Framework of Acceptability (TFA)
Theoretical Framework of Acceptability (TFA) will be collected from SNF Providers to assess acceptability of the STAMP intervention. The TFA is a survey, which includes 8 items rated 1-5 on a Likert scale and summed (higher scores indicate greater acceptability).
Measured: At month 8 of STAMP phase
Pittsburgh Rehabilitation Participation Scale (PRPS)
Patient acceptability of the STAMP intervention will be assessed by mobility aides using the PRPS. The PRPS is a validated, single question, 6-point Likert-scale, rated by the mobility aide, that measures effort and participation. Higher score indicates more acceptability.
Measured: Every patient encounter during STAMP phase
Change in Step Count
Change in daily step count from admission to discharge.
Measured: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Proportion of Patients with Increased Step Count
Of all enrolled patients, proportion achieving ≥20% increase in daily step count from admission to discharge.
Measured: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Change in Short Physical Performance Battery (SPPB)
The SPPB is comprised of 3 tasks: a hierarchical standing balance test (side-by-side, semi-tandem, and tandem), a 4-meter usual gait speed, and a 5-time sit-to-stand from a standardized chair. Each subtask is scored (based on time) from 0-4 points and then summarized into a total score of 0-12 points, where 12 points represents the highest performance. Completion rates and within site pre- to post-STAMP differences will be assessed.
Measured: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Change in Modified Barthel ADL Index (MBI)
The MBI assesses the ability to perform basic Activities of Daily Living (ADL) tasks. Total score range is 0-100. Total score is commuted by summing dependence across 10 ADL tasks: chair/bed transfers, ambulation, stair climbing, toilet transfers, bowel control, bladder control, bathing, dressing, personal hygiene (grooming), and feeding. Higher scores indicate increased independence. Completion rates and within site pre- to post-STAMP differences will be assessed.
Measured: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMay 2028 (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 University of Colorado, DenverThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study model uses pretest-posttest design, with each facility serving as its own control. Two facilities will go through a pre-STAMP phase and a STAMP phase, creating four conditions.
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Aegis Therapies, Inc.
- Responsible party
- Sponsor
- Investigators
- Jennifer Stevens-Lapsley, PT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872384
- Sponsor's protocol ID
- 26-0207
- Other IDs
- 1R21AG095336-01A1
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team guarantees that any and all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. Data will be made available in a timely manner to the broader scientific community, and will be complete, and as accurate as possible. All data released will be de-identified, with no information that could be linked to any study subjects, or participating study practices to ensure the confidentiality of all subjects and practices. If necessary, a data use agreement will be established.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functional Recovery in Skilled Nursing Facilities Through Supplemental Mobility
- ClinicalTrials.gov ID
- NCT07872384
- Acronym / sponsor ID
- 26-0207
- Keywords
- Rehabilitation, Older Adults, Physical Therapy, Occupational Therapy, i-STRONGER, High-Intensity Rehabilitation, Post-Acute Care, Physical Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Aegis Therapies, Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Oct 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.
This pilot study will evaluate the feasibility of a supplemental mobility intervention, the Safe Transfers And Mobility Program (STAMP). This program will be implemented in patients admitted to skilled nursing facilities (SNFs) following hospitalization. STAMP will be administered by a mobility aide who will support patients in increasing physical activity through walking and transfers outside of structured rehabilitation. Participants will either receive high-intensity rehabilitation (HIR) or usual care rehabilitation, combined with STAMP. The two main aims are: 1) determine the feasibility, acceptability, and safety of STAMP, and 2) evaluate the feasibility and variability of patient physical function outcome measures. The study will provide preliminary data on program delivery and safety to inform the design of a larger trial aimed at identifying the most effective strategies to optimize functional recovery in SNFs.
Detailed description
A substantial portion of older adults receiving care in skilled nursing facilities (SNFs) do not achieve successful outcomes, with nearly 40% unable to return home and up to 29% experiencing hospital readmission an outcome strongly associated with mortality. A major, modifiable contributor to these poor outcomes is reduced physical function. Although SNFs offer structured rehabilitation to address mobility impairments, its effectiveness is undermined by pervasive sedentary behavior. Up to 96% of patients receiving care in SNFs require assistance with mobility, and despite participating in daily rehabilitation, patients average less than 1,000 steps per day.
Our team conducted an NIH-funded pragmatic cluster randomized trial (R01, AG072693) evaluating high-intensity rehabilitation (HIR) to improve functional recovery. This trial provided a strong foundation and highlighted that high-intensity rehabilitation alone may be insufficient if patients remain inactive outside of scheduled sessions.
The purpose of this study is to determine the feasibility of an interdisciplinary, patient-centered mobility program (STAMP) to address common barriers in SNFs (e.g., staff shortages, safety concerns, limited training) and increase daily activity with support from a mobility aide. This aide will support patients in walking and functional transfers outside of formal therapy sessions, targeting 45 minutes of additional physical activity to complement structured rehabilitation. This study will explore whether STAMP alone or in combination with HIR offers a scalable strategy to improve function. The study will evaluate STAMP implemented in two settings: one with HIR + STAMP and one with usual care + STAMP. Investigators will determine feasibility, acceptability, and safety of STAMP through a convergent parallel mixed methods approach. Secondarily, investigators will evaluate the feasibility and variability of patient physical function outcome measures to inform outcome selection for future trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study model uses pretest-posttest design, with each facility serving as its own control. Two facilities will go through a pre-STAMP phase and a STAMP phase, creating four conditions.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual Care |
| High Intensity Rehabilitation | Experimental | Other: High Intensity Rehabilitation |
| Usual Care and STAMP | Experimental | Other: Safe Transfers and Mobility Program, Other: Usual Care |
| High Intensity Rehabilitation and STAMP | Experimental | Other: High Intensity Rehabilitation, Other: Safe Transfers and Mobility Program |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 50 years old
- Admitted to SNF from the hospital
- Ambulatory at admission with minimal assistance or less
Key exclusion criteria (4 listed)
- Contraindications to high-intensity resistance training (per American College of Sports Medicine Exercise Testing and Prescription)
- Neurological diagnosis (e.g., cerebral vascular accident, multiple sclerosis, Parkinson's disease, traumatic brain injury)
- Lower extremity weight-bearing precautions that require greater than minimal assistance with ambulation
- Subsequent SNF admission
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 |
|---|---|---|
| High Intensity RehabilitationAn 8RM is the dose necessary for most effective strength gains in community-dwelling older adults, and is equivalent to 80% of a one repetition max, which is the maximal load needed to voluntarily complete one repetition of a given exercise with proper form. Activities will include strength training, transfer practice, balance training, advanced ADLs. Clinicians will tailor the intervention for each activity to target overload using 8-repetition maximum for resistance training. Other interventions will be performed to muscle failure or inability to complete the final repetition. Failure is the inability to complete a repetition through the full, available range of motion without significant compensation. Further, high-intensity dosing requires continuous, volitional effort from the patient; therefore, incorporation of motivational interviewing strategies across sessions will maximize patient effort and self-efficacy. | Other | High Intensity Rehabilitation, High Intensity Rehabilitation and STAMP |
| Safe Transfers and Mobility ProgramThe Safe Transfers and Mobility Program (STAMP) embeds a mobility aide into daily care. STAMP is a patient-centered, scalable approach to extend the benefits of rehabilitation sessions by increasing mobility throughout the day and reinforcing activity between therapy sessions. Core components are: (1) targeting 45 minutes of additional daily physical activity through support with walking and functional mobility tasks; (2) establishing individualized mobility goals collaboratively set by the therapist and patient, based on functional level; (3) delivering progressive activities with walking distances increased by ~30% weekly, adjusted for patient tolerance; and (4) interdisciplinary coordination to incorporate STAMP sessions into routine care with minimal disruption to clinical workflow. Prior work suggests that 45 minutes of STAMP can at least double daily step counts, and increasing walking distance by 30% per week is feasible even for individuals with low baseline function. | Other | High Intensity Rehabilitation and STAMP, Usual Care and STAMP |
| Usual CareUsual Care SNFs will continue with routine collection and documentation of physical performance outcomes (gait speed, SPPB, Modified Barthel ADL Index) as standard practice. Importantly, the Usual Care SNF including the facility, rehabilitation clinicians, and patients will not have access to i-STRONGER materials. | Other | Usual Care, Usual Care and STAMP |
Primary outcome
Usual Gait Speed
Time frame: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Gait speed will be measured in meters/second using the time it takes to walk a 4-meter path at usual speed using a stopwatch. Completion rates will be collected. Within site pre- to post- STAMP changes will be assessed. Higher gait speed indicates better outcome.
11 secondary outcomes
Feasibility of Intervention Measure (FIM)
Time frame: At end of STAMP phase, approximately 8 months
STAMP Session Adherence Rate
Time frame: Beginning of STAMP phase to end of STAMP phase, approximately 8 months
Modified 30 Second Sit to Stand
Time frame: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Number of Rehospitalizations
Time frame: Up to 8 months of Pre-STAMP phase and 8 months of STAMP phase
STAMP Intervention Fidelity
Time frame: Beginning of STAMP phase to end of STAMP phase, approximately 8 months
Theoretical Framework of Acceptability (TFA)
Time frame: At month 8 of STAMP phase
Pittsburgh Rehabilitation Participation Scale (PRPS)
Time frame: Every patient encounter during STAMP phase
Change in Step Count
Time frame: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Proportion of Patients with Increased Step Count
Time frame: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Change in Short Physical Performance Battery (SPPB)
Time frame: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
Change in Modified Barthel ADL Index (MBI)
Time frame: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
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 13 Oct 2026.
- Individual participant dataSharing planned: Yes. The study team guarantees that any and all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. Data will be made available in a timely manner to the broader scientific community, and will be complete, and as accurate as possible. All data released will be de-identified, with no information that could be linked to any study subjects, or participating study practices to ensure the confidentiality of all subjects and practices. If necessary, a data use agreement will be established.
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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.
University of Colorado Denver, Anschutz Medical Campus
Aurora, United States
Jennifer Stevens-Lapsley, PT, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Rehabilitation and Safe Transfers and Mobility Program in people with Aging and Functional Recovery, run by University of Colorado, Denver 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 3 inclusion and 4 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 13 Oct 2026. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usual Gait Speed (time frame: Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days). 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 13 Oct 2026.