Improving Function in Older Veterans With Hospital-Associated Deconditioning

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2021-10-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Development of a Power Training Program to Improve Mobility in Older Veterans

NCT07210645

Physical Deconditioning Mobility Decline

NOT_YET_RECRUITING NA

Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients

NCT02300896

Functional Impairment Cognitive Impairment Elderly

UNKNOWN NA

High Intensity Interval Training (HIIT) to Reduce Frailty and Enhance Resilience in Older Veterans

NCT05625204

Frailty

RECRUITING NA

Role of Exercise in Reversal of Hospitalization-associated Disability in Elderly

NCT01901939

Aging

WITHDRAWN NA

Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly

NCT05317338

Old Age; Debility

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frail Elderly Homebound Persons

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Care (UC)

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

Group Type ACTIVE_COMPARATOR

Usual Care (UC)

Intervention Type BEHAVIORAL

Participants in the "Usual Care" group will receive standard physical therapy following discharge from acute hospitalization. The activities of therapy will include basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program.

Progressive High Intensity Therapy

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

Group Type EXPERIMENTAL

Progressive High Intensity Therapy (PHIT)

Intervention Type BEHAVIORAL

Participants in the "Progressive High Intensity Therapy" (PHIT) group will receive high intensity physical therapy following discharge from acute hospitalization. The activities of training will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Like the Usual Care group, the PHIT participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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. The activities of training will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Like the Usual Care group, the PHIT participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program.

Intervention Type BEHAVIORAL

Usual Care (UC)

Participants in the "Usual Care" group will receive standard physical therapy following discharge from acute hospitalization. The activities of therapy will include basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No