Improving Function in Older Veterans With Hospital-Associated Deconditioning

VA Office of Research and Development

Status: Completed

Conditions: Homebound Persons; Frail Elderly

Treatments: Behavioral: Progressive High Intensity Therapy (PHIT); Behavioral: Usual Care (UC)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02696382

E1978-R

15-1571 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 55 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Usual Care (UC)

Active Comparator group

Description:

Participants in the "Usual Care" (UC) group will receive standard, low-intensity physical therapy following discharge from acute hospitalization.

Treatment:

Behavioral: Usual Care (UC)

Progressive High Intensity Therapy

Experimental group

Description:

Participants in the "Progressive High Intensity Therapy" (PHIT) group will receive high intensity physical therapy following discharge from acute hospitalization.

Treatment:

Behavioral: Progressive High Intensity Therapy (PHIT)