Clinical trial NCT02696382: Improving Function in Older Veterans With Hospital-Associated Deconditioning
Official title: Improving Function in Older Veterans With Hospital-associated Deconditioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Homebound Persons
Keywords: Veterans
Progressive High Intensity Physical Therapy
Gait Speed
Acute Hospitalization
Hospital Associated Deconditioning
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Colorado, Denver
First posted: 2016-03-02
Enrollment: 240
Sex: ALL
Minimum age (years): 55
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators plan to test an innovative, home-based, short duration, high intensity exercise program designed for application in the immediate post-hospitalization period in older Veterans. Preliminary data suggest a more intensive approach to physical therapy in older adults after hospitalization is safe and maximizes mobility more than usual care. The Veterans participating in the high intensity exercise program will receive therapy utilizing higher resistance exercises. Outcomes from this group will be compared to data collected from the patients receiving standard, lower resistance therapies.

Detailed description: Hospital associated deconditioning is a common and profound contributor to functional decline in older adults. Skeletal muscle weakness and atrophy are commonly observed in older adults with deconditioning after a hospitalizations, leading to chronic functional deficits. This is especially concerning for elderly Veterans, a population who tends to suffer from more chronic conditions and have decreased physical function than the general older adult population. Therefore, Veterans may be at even higher risk for developing disability in activities of daily living after hospitalization and be homebound. Home health physical therapy may be the ideal venue for addressing this functional decline as around 3 million older adults receive home health services following hospital discharge. These services, however, tend to be low intensity and do not appear to adequately address deficits in function or performance of home and community mobility. To address these concerns, the investigators have developed and tested an innovative, short-duration, home-based, high intensity exercise program designed for application immediately following hospitalization. This protocol will dose twelve therapy visits over the course of 30 days to determine whether visit frontloading has any effect on outcomes. The investigators are using a series of high resistance therapy exercises following acute hospitalization to determine if progressive high intensity therapy sustainability improves physical function more than standard home health physical therapy after an acute hospitalization in older Veterans. Outcomes will spotlight physical function, community mobility, Activities of Daily Living, quality of life, and cognition.

Eligibility criteria: Inclusion Criteria:

* Recent hospitalization or period of deconditioning
* Veteran Status
* Referred to or eligible for home health physical therapy
* Have at least 3 comorbid conditions including: Chronic Obstructive Pulmonary Disease (COPD), pneumonia, hypertension, hernia, heart disease, spinal stenosis, atrial fibrillation, post-op bowel surgery, gastrointestinal bleed, chronic ulcerative wounds, depression/ mental health, post-op pancreatic surgery, hypercholesterolemia, dehydration, hypo/hyperthyroid, congestive heart failure, urinary tract infection, diabetes, irritable bowel syndrome, osteoporosis, osteoarthritis, rheumatoid arthritis, gout, peripheral artery disease, syncope, renal failure-no dialysis
* Be ambulatory without human assistance prior to hospitalization

Exclusion Criteria:

* Acute lower extremity fracture with weight-bearing restriction
* Elective joint replacement surgery
* Lower extremity amputation
* Acute cardiac surgery
* Terminal illness
* Cancer
* Alzheimer's disease
* Deep vein thrombosis
* Recent stroke

  * Degenerative neurological conditions
  * Gait speed slower than 0.3 m/s or \>1.0 meters/second
* Inability to walk 10 feet without human assistance --History of illegal substance use

Primary outcomes:
measure: Change in Self-Selected Walking Speed
timeFrame: From baseline to 60 days post-baseline
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline
measure: Short Physical Performance Battery (SPPB)
timeFrame: 30 Days
measure: Short Physical Performance Battery (SPPB)
timeFrame: 60 Days
measure: Short Physical Performance Battery (SPPB)
timeFrame: 90 Days
measure: Short Physical Performance Battery (SPPB)
timeFrame: 180 Days
measure: Timed-Up-And-Go Test
timeFrame: Baseline
measure: Timed-Up-And-Go Test
timeFrame: 30 Days
measure: Timed-Up-And-Go Test
timeFrame: 60 Days
measure: Timed-Up-And-Go Test
timeFrame: 90 Days
measure: Timed-Up-And-Go Test
timeFrame: 180 Days
measure: Modified Physical Performance Test (mPPT)
timeFrame: Baseline
measure: Modified Physical Performance Test (mPPT)
timeFrame: 30 Days
measure: Modified Physical Performance Test (mPPT)
timeFrame: 60 Days
measure: Modified Physical Performance Test (mPPT)
timeFrame: 90 Days
measure: Modified Physical Performance Test (mPPT)
timeFrame: 180 Days
measure: Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor
timeFrame: Baseline
measure: Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor
timeFrame: 30 Days
measure: Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor
timeFrame: 60 Days
measure: Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor
timeFrame: 90 Days
measure: Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor
timeFrame: 180 Days
measure: Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor
timeFrame: Baseline
measure: Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor
timeFrame: 30 Days
measure: Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor
timeFrame: 60 Days
measure: Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor
timeFrame: 90 Days
measure: Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor
timeFrame: 180 Days
measure: Grip Strength: Dominant Hand
timeFrame: Baseline
measure: Grip Strength: Dominant Hand
timeFrame: 30 Days
measure: Grip Strength: Dominant Hand
timeFrame: 60 Days
measure: Grip Strength: Dominant Hand
timeFrame: 90 Days
measure: Grip Strength: Dominant Hand
timeFrame: 180 Days
measure: Self-Selected Walking Speed
timeFrame: Baseline
measure: Self-Selected Walking Speed
timeFrame: 30 Days
measure: Self-Selected Walking Speed
timeFrame: 90 Days
measure: Self-Selected Walking Speed
timeFrame: 180 Days
Other outcomes:
measure: Patient Activation Measure Survey (PAM)
timeFrame: Baseline
measure: Step Count
timeFrame: Baseline
measure: Step Count
timeFrame: 60 Days
measure: Step Count
timeFrame: 180 Days
measure: The Life-Space Assessment Survey
timeFrame: Baseline
measure: The Life-Space Assessment Survey
timeFrame: 30 Days
measure: The Life-Space Assessment Survey
timeFrame: 60 Days
measure: The Life-Space Assessment Survey
timeFrame: 90 Days
measure: The Life-Space Assessment Survey
timeFrame: 180 Days
measure: The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)
timeFrame: Baseline
measure: The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)
timeFrame: 60 Days
measure: The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)
timeFrame: 180 Days
measure: The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)
timeFrame: Baseline
measure: The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)
timeFrame: 60 Days
measure: The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)
timeFrame: 180 Days
measure: St. Louis University Mental Status Examination (SLUMS)
timeFrame: Baseline
measure: St. Louis University Mental Status Examination (SLUMS)
timeFrame: 60 Days
measure: St. Louis University Mental Status Examination (SLUMS)
timeFrame: 180 Days
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Jennifer E. Stevens-Lapsley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Falvey JR, Mangione KK, Stevens-Lapsley JE. Rethinking Hospital-Associated Deconditioning: Proposed Paradigm Shift. Phys Ther. 2015 Sep;95(9):1307-15. doi: 10.2522/ptj.20140511. Epub 2015 Apr 23.
citation: Tinetti ME, Baker D, Gallo WT, Nanda A, Charpentier P, O'Leary J. Evaluation of restorative care vs usual care for older adults receiving an acute episode of home care. JAMA. 2002 Apr 24;287(16):2098-105. doi: 10.1001/jama.287.16.2098.
citation: Andersen LL, Andersen CH, Mortensen OS, Poulsen OM, Bjornlund IB, Zebis MK. Muscle activation and perceived loading during rehabilitation exercises: comparison of dumbbells and elastic resistance. Phys Ther. 2010 Apr;90(4):538-49. doi: 10.2522/ptj.20090167. Epub 2010 Feb 4.
citation: El Solh A, Pineda L, Bouquin P, Mankowski C. Determinants of short and long term functional recovery after hospitalization for community-acquired pneumonia in the elderly: role of inflammatory markers. BMC Geriatr. 2006 Aug 9;6:12. doi: 10.1186/1471-2318-6-12.