Physical DeconditioningNCT02927171
Shifting Rehabilitation Paradigms in Skilled Nursing Facilities
A study testing IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents in people with Physical Deconditioning, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
This study seeks to improve rehabilitation methods for restoring physical function with skilled nursing facility care. More specifically, this study is designed to evaluate the effectiveness of an intensive therapeutic rehabilitation program for older adult skilled nursing home residents compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Deconditioning
- What is being tested?
- IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Feb 2016to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults > 18 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 rather than the proposed high-intensity approach. Such patient populations include:
- Parkinson's Disease
- Traumatic Brain Injury
- Recent Cerebral Vascular Accident
- Alzheimer's Disease
- Patients on hospice care will be excluded as the approach is based on palliative principles.
Show all 19Show fewer
- 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):
- Recent unstable fracture
- Advanced congestive heart failure
- 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 fistula
- Platelet levels <50,000/ L
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
VA Community Living Center
Aurora, Colorado, 80045
Brookdale Senior Living
Denver, Colorado, 80247
About this study
This study seeks to improve rehabilitation methods for restoring physical function with skilled nursing facility care. More specifically, this study is designed to evaluate the effectiveness of an intensive therapeutic rehabilitation program for older adult skilled nursing home residents compared to usual care.
Read the detailed description
There is growing recognition that acute hospitalization contributes to marked functional decline in older adults. Nearly 20% of all hospitalized older adults are discharged to a skilled nursing facility (SNF) to address these functional deficits. However, rehabilitation in SNFs may not adequately restore physical function, which potentially contributes to poor community discharge rates. Strikingly, only 37% of all patients admitted to SNFs are discharged to a community setting, which suggests a paradigm shift is required to optimize rehabilitation within SNFs. Currently, usual care rehabilitation in SNFs consists of low-intensity rehabilitation interventions, which are physiologically inadequate to induce meaningful changes in skeletal muscle strength and physical function. Therefore, the investigators propose a novel "IntenSive Therapeutic Rehabilitation for Older skilled NursinG HomE Residents" (I-STRONGER) program, which integrates principles of physiologic tissue overload into combined strengthening and functional interventions for greater gains in physical function. The overall goals of this investigation are to 1) demonstrate feasibility of I-STRONGER in SNF settings and 2) determine the effectiveness of I-STRONGER in improving physical function. A comparison of usual care (UC) with I-STRONGER will occur using a staged, 2 group design (independent cohorts), with a single SNF serving as its own control. The first cohort of SNF patients will participate in UC (Stage 1) and after therapist training on ISTRONGER is completed, a second cohort of patients entering the same facility will participate in I-STRONGER (Stage 2). The feasibility of I-STRONGER will be evaluated by patient acceptability and therapist compliance measures. Sample size estimates (using patients with mobility deficits in home health settings) suggest at least 86 participants are necessary to be adequately powered. Heterogeneity of the sample will be re-evaluated during the study period using SNF data and sample size estimates may be adjusted as appropriate.
- Conditions
- Physical Deconditioning
- Being tested
- IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents
- Keywords
- Skilled Nursing Facility, Post-Acute Care, Older Adults, Physical Function, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home ResidentsOther
Also called I-STRONGER
Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care. |
| I-STRONGER | Experimental | IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. Receives: Other: IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents |
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. Minimum scores are 0 and maximum scores are 12. Higher scores indicate better function.
Measured: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)
Secondary outcomes (1)
Gait Speed
Time it takes to walk a 4 meter path. Lower scores indicate better function.
Measured: Change from SNF Admission to SNF 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 posted6 Oct 2016 (estimated)
- Study start28 Feb 2016
- Primary completion30 Oct 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical DeconditioningStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Denver
- 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
- NCT02927171
- Sponsor's protocol ID
- E2193-P
- Other IDs
- I21RX002193
- Status last verified
- Mar 2020
- First submitted
- 26 Sep 2016
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 23850612Peterson MJ, Crowley GM, Sullivan RJ, Morey MC. Physical function in sedentary and exercising older veterans as compared to national norms. J Rehabil Res Dev. 2004 Sep;41(5):653-8. doi: 10.1682/jrrd.2003.09.0141.
PubMed 15558394
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shifting Rehabilitation Paradigms in Skilled Nursing Facilities
- ClinicalTrials.gov ID
- NCT02927171
- Acronym / sponsor ID
- E2193-P
- Conditions
- Physical Deconditioning
- Keywords
- Skilled Nursing Facility, Post-Acute Care, Older Adults, Physical Function, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Colorado, Denver
- Study start
- 28 Feb 2016 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Posted 3 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to improve rehabilitation methods for restoring physical function with skilled nursing facility care. More specifically, this study is designed to evaluate the effectiveness of an intensive therapeutic rehabilitation program for older adult skilled nursing home residents compared to usual care.
Detailed description
There is growing recognition that acute hospitalization contributes to marked functional decline in older adults. Nearly 20% of all hospitalized older adults are discharged to a skilled nursing facility (SNF) to address these functional deficits. However, rehabilitation in SNFs may not adequately restore physical function, which potentially contributes to poor community discharge rates. Strikingly, only 37% of all patients admitted to SNFs are discharged to a community setting, which suggests a paradigm shift is required to optimize rehabilitation within SNFs. Currently, usual care rehabilitation in SNFs consists of low-intensity rehabilitation interventions, which are physiologically inadequate to induce meaningful changes in skeletal muscle strength and physical function. Therefore, the investigators propose a novel "IntenSive Therapeutic Rehabilitation for Older skilled NursinG HomE Residents" (I-STRONGER) program, which integrates principles of physiologic tissue overload into combined strengthening and functional interventions for greater gains in physical function. The overall goals of this investigation are to 1) demonstrate feasibility of I-STRONGER in SNF settings and 2) determine the effectiveness of I-STRONGER in improving physical function. A comparison of usual care (UC) with I-STRONGER will occur using a staged, 2 group design (independent cohorts), with a single SNF serving as its own control. The first cohort of SNF patients will participate in UC (Stage 1) and after therapist training on ISTRONGER is completed, a second cohort of patients entering the same facility will participate in I-STRONGER (Stage 2). The feasibility of I-STRONGER will be evaluated by patient acceptability and therapist compliance measures. Sample size estimates (using patients with mobility deficits in home health settings) suggest at least 86 participants are necessary to be adequately powered. Heterogeneity of the sample will be re-evaluated during the study period using SNF data and sample size estimates may be adjusted as appropriate.
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 | –Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care. |
| I-STRONGER | Experimental | Other: IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home ResidentsIntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults > 18 years of age who are admitted to a skilled nursing facility following hospitalization
- Qualify to receive at least physical therapy services
Key exclusion criteria (19 listed)
- Patients with primary diagnoses related to neurological disorders will be excluded as patient needs require more of a motor control approach rather than 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
- Recent unstable fracture
- Advanced congestive heart failure
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 |
|---|---|---|
| IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home ResidentsAlso: I-STRONGERProgressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. | Other | I-STRONGER |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)
Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests. Minimum scores are 0 and maximum scores are 12. Higher scores indicate better function.
1 secondary outcome
Gait Speed
Time frame: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
- Results publication: PubMed 15558394Peterson MJ, Crowley GM, Sullivan RJ, Morey MC. Physical function in sedentary and exercising older veterans as compared to national norms. J Rehabil Res Dev. 2004 Sep;41(5):653-8. doi: 10.1682/jrrd.2003.09.0141.
- Individual participant dataSharing planned: No
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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 E. Stevens-Lapsley, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents in people with Physical Deconditioning, run by VA Office of Research and Development at 3 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 2 inclusion and 19 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 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 3 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 SNF Admission to SNF 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?
On the ClinicalTrials.gov record for NCT02927171, which also lists 2 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 3 Apr 2020.