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Clinical Trials/NCT02696382
NCT02696382CompletedNot Applicable

Improving Function in Older Veterans With Hospital-associated Deconditioning

VA Office of Research and Development1 site in 1 country240 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
240
Locations
1
Primary Endpoint
Change in Self-Selected Walking Speed

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
55 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • 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

Arms & Interventions

Usual Care (UC)

Active Comparator

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

Intervention: Usual Care (UC) (Behavioral)

Progressive High Intensity Therapy

Experimental

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

Intervention: Progressive High Intensity Therapy (PHIT) (Behavioral)

Outcomes

Primary Outcomes

Change in Self-Selected Walking Speed

Time Frame: From baseline to 60 days post-baseline

Will be assessed at the subject's self selected speed for each participant over 4 meters. Faster walking indicates capacity for performance of certain activities (e.g. crossing a street before the light changes).

Secondary Outcomes

  • Grip Strength: Dominant Hand(180 Days)
  • Self-Selected Walking Speed(180 Days)
  • Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor(180 Days)
  • Modified Physical Performance Test (mPPT)(180 Days)
  • Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor(180 Days)
  • Short Physical Performance Battery (SPPB)(180 Days)
  • Timed-Up-And-Go Test(180 Days)
  • Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor(30 Days)
  • Short Physical Performance Battery (SPPB)(Baseline)
  • Short Physical Performance Battery (SPPB)(30 Days)
  • Short Physical Performance Battery (SPPB)(60 Days)
  • Short Physical Performance Battery (SPPB)(90 Days)
  • Timed-Up-And-Go Test(Baseline)
  • Timed-Up-And-Go Test(30 Days)
  • Timed-Up-And-Go Test(60 Days)
  • Timed-Up-And-Go Test(90 Days)
  • Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor(60 Days)
  • Modified Physical Performance Test (mPPT)(Baseline)
  • Modified Physical Performance Test (mPPT)(30 Days)
  • Modified Physical Performance Test (mPPT)(60 Days)
  • Modified Physical Performance Test (mPPT)(90 Days)
  • Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor(Baseline)
  • Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor(90 Days)
  • Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor(Baseline)
  • Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor(30 Days)
  • Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor(60 Days)
  • Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor(90 Days)
  • Grip Strength: Dominant Hand(Baseline)
  • Grip Strength: Dominant Hand(30 Days)
  • Grip Strength: Dominant Hand(60 Days)
  • Grip Strength: Dominant Hand(90 Days)
  • Self-Selected Walking Speed(Baseline)
  • Self-Selected Walking Speed(30 Days)
  • Self-Selected Walking Speed(90 Days)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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