Physical Deconditioning
Conditions
Keywords
Skilled Nursing Facility, Post-Acute Care, Older Adults, Physical Function, Rehabilitation
Brief 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.
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.
Interventions
OTHERIntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents
Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
Sponsors
University of Colorado, Denver
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults \> 18 years of age who are admitted to a skilled nursing facility following hospitalization 2. Qualify to receive at least physical therapy services
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery (SPPB) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed | Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days) | Time it takes to walk a 4 meter path. Lower scores indicate better function. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Survey | Quantification at SNF Discharge (Expected average length of stay: 21 days) | 8 Question survey, scoring each questions on a 1-10 scale (1=not at all, 10=extremely). Higher scores indicate higher satisfaction. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from a skilled nursing facility between the dates of 02.28.2016 and 10.30.2018
Pre-assignment details
There were no exclusions of participants. All eligible, willing participants were allocated to one of two arms.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care. | 53 |
| I-STRONGER 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.
IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. | 50 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Total | I-STRONGER |
|---|---|---|---|
| Age, Continuous | 78.0 years STANDARD_DEVIATION 9.6 | 77.65 years STANDARD_DEVIATION 10.2 | 77.3 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 94 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 28 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) White | 34 Participants | 65 Participants | 31 Participants |
| Region of Enrollment United States | 53 Participants | 103 Participants | 50 Participants |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 2 Participants |
| Sex: Female, Male Male | 44 Participants | 92 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 50 |
| other Total, other adverse events | 0 / 53 | 0 / 50 |
| serious Total, serious adverse events | 0 / 53 | 0 / 50 |
Outcome results
Primary
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.
Time frame: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Short Physical Performance Battery (SPPB) | 3.6 score on a scale | Standard Deviation 2.3 |
| I-STRONGER | Short Physical Performance Battery (SPPB) | 4.3 score on a scale | Standard Deviation 2.7 |
p-value: 0.17t-test, 1 sided
Secondary
Gait Speed
Time it takes to walk a 4 meter path. Lower scores indicate better function.
Time frame: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Gait Speed | 0.3 seconds | Standard Deviation 0.2 |
| I-STRONGER | Gait Speed | 0.5 seconds | Standard Deviation 0.3 |
Other Pre-specified
Patient Satisfaction Survey
8 Question survey, scoring each questions on a 1-10 scale (1=not at all, 10=extremely). Higher scores indicate higher satisfaction.
Time frame: Quantification at SNF Discharge (Expected average length of stay: 21 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Patient Satisfaction Survey | 54.6 score on a scale | Standard Deviation 7.9 |
| I-STRONGER | Patient Satisfaction Survey | 59.4 score on a scale | Standard Deviation 7.3 |