Improving Function in Older Veterans With Hospital-Associated Deconditioning

Not Applicable

Completed

• Conditions: Homebound Persons; Frail Elderly
• Interventions: Behavioral: Usual Care (UC); Behavioral: Progressive High Intensity Therapy (PHIT)

• Registration Number: NCT02696382
• Lead Sponsor: VA Office of Research and Development

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 Timeline

• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Study Start: 2016-04-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-10-08
• Results First Submitted: 2022-09-02
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Results First Posted: 2024-04-01
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care (UC)	Usual Care (UC)	Participants in the "Usual Care" (UC) group will receive standard, low-intensity physical therapy following discharge from acute hospitalization.
Progressive High Intensity Therapy	Progressive High Intensity Therapy (PHIT)	Participants in the "Progressive High Intensity Therapy" (PHIT) group will receive high intensity physical therapy following discharge from acute hospitalization.

Primary Outcome Measures

Name	Time	Method
Change in Self-Selected Walking Speed	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 Outcome Measures

Name	Time	Method
Modified Physical Performance Test (mPPT)	180 Days	mPPT assesses 7 tasks. Based on the time it takes to complete each task, a score from 0 (unable to complete) to 4 (performed quickly and easily) is given for each item. The maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders.
Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor	180 Days	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.
Grip Strength: Dominant Hand	180 Days	Grip strength was measured on the dominant hand using a hand dynamometer with the participant seated and elbow positioned at 90 degrees of flexion with the arm resting against the trunk. Maximal grip strength during a 3 second hold was measured for at least 2 trials and a 3rd trial was allowed if differences between trials were \> 5%. Higher numbers indicate greater strength (better outcome).
Self-Selected Walking Speed	180 Days	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).
Short Physical Performance Battery (SPPB)	180 Days	The SPPB is a well-accepted global measure of lower extremity function which consists of a composite measure including walking speed, chair stands, and balance. It is a strong predictor of disability, institutionalization, and morbidity in older adults. The SPPB is comprised of 3 tasks: a hierarchical standing balance test (side-by-side, semi-tandem, and tandem), a 4-meter usual gait speed, and a 5-time sit-to-stand from a standardized chair. Each subtask is scored (based on time) from 0-4 points and then summarized into a total score of 0-12 points, where 12 points represents the highest performance.
Timed-Up-And-Go Test	180 Days	The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance. This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). Faster times indicate a better outcome.
Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor	180 Days	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.

Trial Locations

Locations (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO; 🇺🇸 Aurora, Colorado, United States