Physical DisabilityNCT04300413
Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility
A study testing High-Intensity Rehabilitation plus Mobility (HeRo) in people with Physical Disability, run by University of Colorado, Denver at 1 site in United States.
Trial summary
During a hospital stay, older adults often become physically deconditioned and lose their ability to perform activities of daily living. Afterwards, they commonly require rehabilitation in a skilled nursing facility to regain independence. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Physical Disability
- What is being tested?
- High-Intensity Rehabilitation plus Mobility (HeRo)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2020to 9 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 50 who are admitted to a skilled nursing facility following hospitalization
- Qualify to receive at least physical therapy services
- Ambulatory prior to hospitalization
Who cannot join
- Patients with neurological disorders such as acute stroke or acute traumatic brain injury
- Patients on hospice care
- Patient with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription):
- Recent unstable fracture
- Advanced congestive heart failure
- Bone metastasis sites
Show all 15Show fewer
- Tumors in strengthening target areas
- Acute Illness
- Recent myocardial infarction (within 3-6 weeks)
- Weight bearing restrictions on graft or fracture sites
- Exposed tendon or muscle
- Absence of pedal pulses
- Presence of fistula
- Platelet levels <50,000/μL
- Weight-bearing precautions and inability to ambulate prior to hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Community Living Center at Fitzsimmons
Aurora, Colorado, 80045
About this study
During a hospital stay, older adults often become physically deconditioned and lose their ability to perform activities of daily living. Afterwards, they commonly require rehabilitation in a skilled nursing facility to regain independence. Even at discharge, however, many older adults are still far below their pre-hospitalization level of function making them at risk for adverse events such as falls, rehospitalizations, and loss of independence. Two reasons for inadequate outcomes may include that 1) physical and occupational therapy interventions are delivered at too low an intensity to incur substantial physiological gains, and 2) residents are largely sedentary outside of structured therapy time. These two problems represent critical targets for interventions that optimize care in skilled nursing facilities. Therefore, the investigators designed High-Intensity Rehabilitation + Mobility (HeRo), a patient-centered approach to skilled nursing facility care that incorporates a combination of high-intensity (i.e. high resistance, low repetition) functionally-based resistance training along with a structured mobility program outside of therapy time.
HeRo includes: 1) a team approach to patient-centered care; 2) a physical activity intervention that incorporates principals of behavioral economics, which uses incentives, goal setting, and gamification to optimize patient engagement and health outcomes and 3) a challenging, high-intensity rehabilitation intervention that pushes patients to expand their limits. The investigators expect that HeRo will improve physical function and physical activity while reducing sedentary time for older adults in the skilled nursing facility. The study team will assess the feasibility and acceptability of HeRo for multiple stakeholders including patients, physical and occupational therapists, nursing staff, and administration. This research will improve patient care in the skilled nursing facility environment, getting older adults on a fast track to developing independence after a hospital stay.
- Conditions
- Physical Disability
- Being tested
- High-Intensity Rehabilitation plus Mobility (HeRo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Rehabilitation plus Mobility (HeRo)Other
Progressive, high-intensity strengthening and functional intervention coupled with structured mobility based in principals of behavioral economics.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Rehabilitation plus Mobility (HeRo) | Experimental | The HeRo group will receive a behavior-change intervention based in the principals of behavioral economics to improve mobility. Physical and occupational therapists have been trained to deliver a high-intensity, functional intervention as the standard of care in this skilled nursing facility. Receives: Other: High-Intensity Rehabilitation plus Mobility (HeRo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Time it takes to walk 4 meters (meters per second)
Measured: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days
Secondary outcomes (1)
Short Physical Performance Battery (SPPB)
Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests
Measured: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start16 Feb 2020
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm study but will use two historical cohorts as comparison groups to assess outcomes: 1) usual care and 2) high-intensity, functionally based resistance training alone. The historical cohorts were included in a previous study (Clinical Trials Registry identifier: E2193-P). This design will include independent cohorts of patients within a single SNF, using the facility as its own control. This design optimally controls for facility-level variables that vary widely between SNFs and may influence care delivery, such as staffing levels, staff experience, and productivity standards.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Stevens-Lapsley, PT, PhD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300413
- Sponsor's protocol ID
- 19-2490
- Status last verified
- Jul 2022
- First submitted
- 24 Feb 2020
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mallinson T, Deutsch A, Bateman J, Tseng HY, Manheim L, Almagor O, Heinemann AW. Comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after hip fracture repair. Arch Phys Med Rehabil. 2014 Feb;95(2):209-17. doi: 10.1016/j.apmr.2013.05.031. Epub 2013 Jul 10.
PubMed 23850612Simning A, Caprio TV, Seplaki CL, Temkin-Greener H, Szanton SL, Conwell Y. Patient-Reported Outcomes in Functioning Following Nursing Home or Inpatient Rehabilitation. J Am Med Dir Assoc. 2018 Oct;19(10):864-870. doi: 10.1016/j.jamda.2018.06.014. Epub 2018 Jul 25.
PubMed 30056009Grant PM, Granat MH, Thow MK, Maclaren WM. Analyzing free-living physical activity of older adults in different environments using body-worn activity monitors. J Aging Phys Act. 2010 Apr;18(2):171-84. doi: 10.1123/japa.18.2.171.
PubMed 20440029
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility
- ClinicalTrials.gov ID
- NCT04300413
- Acronym / sponsor ID
- 19-2490
- Conditions
- Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 16 Feb 2020 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 9 Mar 2020 (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.
During a hospital stay, older adults often become physically deconditioned and lose their ability to perform activities of daily living. Afterwards, they commonly require rehabilitation in a skilled nursing facility to regain independence. Even at discharge, however, many older adults are still far below their pre-hospitalization level of function making them at risk for adverse events such as falls, rehospitalizations, and loss of independence. Two reasons for inadequate outcomes may include that 1) physical and occupational therapy interventions are delivered at too low an intensity to incur substantial physiological gains, and 2) residents are largely sedentary outside of structured therapy time. These two problems represent critical targets for interventions that optimize care in skilled nursing facilities. Therefore, the investigators designed High-Intensity Rehabilitation + Mobility (HeRo), a patient-centered approach to skilled nursing facility care that incorporates a combination of high-intensity (i.e. high resistance, low repetition) functionally-based resistance training along with a structured mobility program outside of therapy time.
HeRo includes: 1) a team approach to patient-centered care; 2) a physical activity intervention that incorporates principals of behavioral economics, which uses incentives, goal setting, and gamification to optimize patient engagement and health outcomes and 3) a challenging, high-intensity rehabilitation intervention that pushes patients to expand their limits. The investigators expect that HeRo will improve physical function and physical activity while reducing sedentary time for older adults in the skilled nursing facility. The study team will assess the feasibility and acceptability of HeRo for multiple stakeholders including patients, physical and occupational therapists, nursing staff, and administration. This research will improve patient care in the skilled nursing facility environment, getting older adults on a fast track to developing independence after a hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm study but will use two historical cohorts as comparison groups to assess outcomes: 1) usual care and 2) high-intensity, functionally based resistance training alone. The historical cohorts were included in a previous study (Clinical Trials Registry identifier: E2193-P). This design will include independent cohorts of patients within a single SNF, using the facility as its own control. This design optimally controls for facility-level variables that vary widely between SNFs and may influence care delivery, such as staffing levels, staff experience, and productivity standards.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Rehabilitation plus Mobility (HeRo) | Experimental | Other: High-Intensity Rehabilitation plus Mobility (HeRo)The HeRo group will receive a behavior-change intervention based in the principals of behavioral economics to improve mobility. Physical and occupational therapists have been trained to deliver a high-intensity, functional intervention as the standard of care in this skilled nursing facility. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 50 who are admitted to a skilled nursing facility following hospitalization
- Qualify to receive at least physical therapy services
- Ambulatory prior to hospitalization
Key exclusion criteria (15 listed)
- Patients with neurological disorders such as acute stroke or acute traumatic brain injury
- Patients on hospice care
- Patient with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription):
- Weight-bearing precautions and inability to ambulate prior to hospitalization
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 Rehabilitation plus Mobility (HeRo)Progressive, high-intensity strengthening and functional intervention coupled with structured mobility based in principals of behavioral economics. | Other | High-Intensity Rehabilitation plus Mobility (HeRo) |
Primary outcome
Gait Speed
Time frame: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days
Time it takes to walk 4 meters (meters per second)
1 secondary outcome
Short Physical Performance Battery (SPPB)
Time frame: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days
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 13 Jul 2022.
- Background: PubMed 23850612Mallinson T, Deutsch A, Bateman J, Tseng HY, Manheim L, Almagor O, Heinemann AW. Comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after hip fracture repair. Arch Phys Med Rehabil. 2014 Feb;95(2):209-17. doi: 10.1016/j.apmr.2013.05.031. Epub 2013 Jul 10.
- Background: PubMed 30056009Simning A, Caprio TV, Seplaki CL, Temkin-Greener H, Szanton SL, Conwell Y. Patient-Reported Outcomes in Functioning Following Nursing Home or Inpatient Rehabilitation. J Am Med Dir Assoc. 2018 Oct;19(10):864-870. doi: 10.1016/j.jamda.2018.06.014. Epub 2018 Jul 25.
- Background: PubMed 20440029Grant PM, Granat MH, Thow MK, Maclaren WM. Analyzing free-living physical activity of older adults in different environments using body-worn activity monitors. J Aging Phys Act. 2010 Apr;18(2):171-84. doi: 10.1123/japa.18.2.171.
- Individual participant dataSharing planned: No
Related trials for Physical Disability
Not yet recruiting
Examining the Health Impact of and Promoting Sitting Light Volleyball in the Greater Bay Area
Physial Disabilities
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Recruiting
The STRIVE Before Surgery Trial
Surgery-Complications, Disability Physical
Active, not recruitingObservational study
Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients
Multiple Sclerosis
Not yet recruitingObservational study
A Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status.
Scleroderma
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.
Jennifer Stevens-Lapsley, PT, PhD principal investigator
University of Colorado School of Medicine
1 site 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 plus Mobility (HeRo) in people with Physical Disability, run by University of Colorado, Denver 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 3 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 13 Jul 2022. 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?
Gait Speed (time frame: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days). 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 NCT04300413, which also lists 3 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 13 Jul 2022.