Physical DeconditioningSNFNCT02421692
Improving Physical Function in Skilled Nursing Facility Residents
A study testing Progressive Rehabilitation in people with Physical Deconditioning, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Each year Medicare spends approximately $31.3 billion on 2.4 million skilled nursing facility (SNF) episodes of care. SNFs rely on interdisciplinary approaches to patient care to maximize rehabilitation potential for return to prior level of function and reduce the risk of adverse events in older adults. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Physical Deconditioning
- What is being tested?
- Progressive Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Nov 2016
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults older ≥55 years of age who are admitted to a skilled nursing facility following hospitalization
- Qualify to receive at least physical therapy services.
Who cannot join
- Patients with primary diagnoses related to neurological disorders will be excluded as patient needs require more of a motor-control approach versus the proposed high-intensity approach. Such patient populations include:
- Parkinson's Disease
- Traumatic Brain Injury
- Recent Cerebral Vascular Accident
- Alzheimer's
- Patients on hospice care will be excluded as the approach is based on palliative principles. Other patients to be excluded will include those with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription):
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- Recent unstable fractures
- Advanced congestive heart failure (ejection fracture <30%)
- Bone metastasis sites
- 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 a fistula
- Platelet levels <50,000/µL.
- Additional exclusions assessed prior to randomization include a score of less than 21 on the Mini-Mental Status Exam.
Trial locations and contacts
1 site in 1 country.
About this study
Each year Medicare spends approximately $31.3 billion on 2.4 million skilled nursing facility (SNF) episodes of care. SNFs rely on interdisciplinary approaches to patient care to maximize rehabilitation potential for return to prior level of function and reduce the risk of adverse events in older adults. However despite a substantial increase in spending on SNF services and minimal change in complexity of the caseload, 68% of patients are below their pre-hospitalization level of function at discharge, 25% return to the community, and 18% are hospitalized. This may be partially explained by current SNF approaches to patient care which foster inactivity and participation in low intensity rehabilitation interventions (preliminary data). Both inactivity and low-intensity interventions may perpetuate further functional decline or impede maximal recovery. The serious implication of risk with functional decline is exemplified by studies which have shown declines in physical function can increase the risk of being re-hospitalized six-fold and may infer other long term effects such as increased risk for mortality, morbidity, and institutionalization. Muscle weakness, reduced cardiorespiratory reserve, and neuromuscular deficits have been attributed to this acute decline in function. However current rehabilitation strategies in SNFs do not promote adequate dose and mode of interventions to induce beneficial systemic adaptations, perhaps due to the lack of evidence on effective rehabilitation protocols for this medically-complex population. Therefore, the investigators have designed an rehabilitation program, which uniquely integrates principles of physiologic tissue overload with strengthening and functional interventions for greater gains in physical function. Data will be collected on the first cohort of patients who cycle through a SNF during Stage 1, in which usual care occurs (5 months). Then, staff training on progressive rehabilitation interventions will occur over 2 months. Finally, data will be collected on a second cohort of patients who cycle through a SNF during Stage 2, in which progressive rehabilitation is implemented by SNF staff (5 months). Given the high turnover of patients in SNFs (average length of stay ~21 days), 2 different cohorts of patients will be studied and the analysis will consist of independent 2-sample t-tests. During Stage 1 and 2, measures of physical function will be assessed on all eligible patients at admission and discharge from SNF. Therapists will be assessed on adherence to the protocol through documentation audits and use of on-site observational checklist. Acceptability of the intervention by the patients will be assessed by a patient satisfaction survey. Any adverse events will be obtained from the medical record and documented. The discharge location of all patients will be documented.
- Conditions
- Physical Deconditioning
- Being tested
- Progressive Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive RehabilitationOther
Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | SNF rehabilitation therapists provide all patients with usual standard of care. |
| Progressive Rehabilitation | Experimental | SNF rehabilitation therapists have been trained on principles of progressive rehabilitation strategies and will implement to all eligible patients as new standard of care. Receives: Other: Progressive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests
Measured: Change from Admission to Discharge (expected average length of stay 21 days)
Secondary outcomes (1)
Gait Speed
Time it takes to walk a 4 meter path
Measured: Change from Admission to Discharge (expected average length of stay 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DeconditioningStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 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, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421692
- Sponsor's protocol ID
- 14-2388
- Acronym
- SNF
- Status last verified
- Nov 2016
- First submitted
- 13 Mar 2015
- Last updated
- 15 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Function in Skilled Nursing Facility Residents
- ClinicalTrials.gov ID
- NCT02421692
- Acronym / sponsor ID
- SNF / 14-2388
- Conditions
- Physical Deconditioning
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Apr 2015 (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.
Each year Medicare spends approximately $31.3 billion on 2.4 million skilled nursing facility (SNF) episodes of care. SNFs rely on interdisciplinary approaches to patient care to maximize rehabilitation potential for return to prior level of function and reduce the risk of adverse events in older adults. However despite a substantial increase in spending on SNF services and minimal change in complexity of the caseload, 68% of patients are below their pre-hospitalization level of function at discharge, 25% return to the community, and 18% are hospitalized. This may be partially explained by current SNF approaches to patient care which foster inactivity and participation in low intensity rehabilitation interventions (preliminary data). Both inactivity and low-intensity interventions may perpetuate further functional decline or impede maximal recovery. The serious implication of risk with functional decline is exemplified by studies which have shown declines in physical function can increase the risk of being re-hospitalized six-fold and may infer other long term effects such as increased risk for mortality, morbidity, and institutionalization. Muscle weakness, reduced cardiorespiratory reserve, and neuromuscular deficits have been attributed to this acute decline in function. However current rehabilitation strategies in SNFs do not promote adequate dose and mode of interventions to induce beneficial systemic adaptations, perhaps due to the lack of evidence on effective rehabilitation protocols for this medically-complex population. Therefore, the investigators have designed an rehabilitation program, which uniquely integrates principles of physiologic tissue overload with strengthening and functional interventions for greater gains in physical function. Data will be collected on the first cohort of patients who cycle through a SNF during Stage 1, in which usual care occurs (5 months). Then, staff training on progressive rehabilitation interventions will occur over 2 months. Finally, data will be collected on a second cohort of patients who cycle through a SNF during Stage 2, in which progressive rehabilitation is implemented by SNF staff (5 months). Given the high turnover of patients in SNFs (average length of stay ~21 days), 2 different cohorts of patients will be studied and the analysis will consist of independent 2-sample t-tests. During Stage 1 and 2, measures of physical function will be assessed on all eligible patients at admission and discharge from SNF. Therapists will be assessed on adherence to the protocol through documentation audits and use of on-site observational checklist. Acceptability of the intervention by the patients will be assessed by a patient satisfaction survey. Any adverse events will be obtained from the medical record and documented. The discharge location of all patients will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –SNF rehabilitation therapists provide all patients with usual standard of care. |
| Progressive Rehabilitation | Experimental | Other: Progressive RehabilitationSNF rehabilitation therapists have been trained on principles of progressive rehabilitation strategies and will implement to all eligible patients as new standard of care. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults older ≥55 years of age who are admitted to a skilled nursing facility following hospitalization
- Qualify to receive at least physical therapy services.
Key exclusion criteria (18 listed)
- Patients with primary diagnoses related to neurological disorders will be excluded as patient needs require more of a motor-control approach versus the proposed high-intensity approach. Such patient populations include:
- Patients on hospice care will be excluded as the approach is based on palliative principles. Other patients to be excluded will include those with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription):
- Additional exclusions assessed prior to randomization include a score of less than 21 on the Mini-Mental Status Exam.
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 |
|---|---|---|
| Progressive RehabilitationProgressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. | Other | Progressive Rehabilitation |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: Change from Admission to Discharge (expected average length of stay 21 days)
Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests
1 secondary outcome
Gait Speed
Time frame: Change from Admission to Discharge (expected average length of stay 21 days)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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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.
Jennifer Stevens-Lapsley, PT, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Rehabilitation in people with Physical Deconditioning, 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 2 inclusion and 18 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: stopped early, as of the sponsor's last update on 15 Nov 2016. 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 was stopped early. Results are not available in the source record.
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?
Short Physical Performance Battery (SPPB) (time frame: Change from Admission to Discharge (expected average length of stay 21 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 15 Nov 2016.