Improving Physical Function in Skilled Nursing Facility Residents

Physical Deconditioning Clinical Trial

— SNF  

Official title:

Improving Physical Function in Skilled Nursing Facility Residents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02421692
• Other study ID #: 14-2388
• Status: Terminated
• Phase: N/A
• First received: March 13, 2015
• Last updated: November 11, 2016
• Start date: April 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 153
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Adults older =55 years of age who are admitted to a skilled nursing facility following hospitalization

2. Qualify to receive at least physical therapy services.

Exclusion Criteria:

1. 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:

1. Parkinson's Disease

2. Traumatic Brain Injury

3. Recent Cerebral Vascular Accident

4. Alzheimer's

2. 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):

1. Recent unstable fractures

2. Advanced congestive heart failure (ejection fracture <30%)

3. Bone metastasis sites

4. Tumors in strengthening target areas

5. Acute illness

6. Recent myocardial infarction (within 3-6 weeks)

7. Weight bearing restrictions on graft or fracture sites

8. Exposed tendon or muscle

9. Absence of pedal pulses

10. Presence of a fistula

11. Platelet levels <50,000/µL.

3. Additional exclusions assessed prior to randomization include a score of less than 21 on the Mini-Mental Status Exam.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Physical Deconditioning

Intervention

Other:
• Progressive Rehabilitation
Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.

Locations

Country	Name	City	State
United States	Gardens on Quail	Arvada	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction Survey	8 question survey, scoring each question on a 1-10 scale (1=not at all and 10=extremely)	Discharge (expected average length of stay 21 days)	No
Other	Therapist Intervention Compliance	Audits of therapist documentation and on-site observations with an objective checklist during treatment sessions	Bi-weekly for 5 months during intervention arm	No
Other	Discharge Location	Record the discharge location of individuals	Discharge (expected average length of stay 21 days)	No
Primary	Short Physical Performance Battery (SPPB)	Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests	Change from Admission to Discharge (expected average length of stay 21 days)	No
Secondary	Gait Speed	Time it takes to walk a 4 meter path	Change from Admission to Discharge (expected average length of stay 21 days)	No