N/A
N=150
Improving Function in Older Veterans With Hospital-Associated Deconditioning
Frail Elderly · Homebound Persons
Bottom Line
View on ClinicalTrials.gov: NCT02696382 ↗Enrolled (actual)
150
Serious AEs
44.7%
Results posted
Apr 2024
Primary outcome: Primary: Change in Self-Selected Walking Speed — 0.08; 0.08 m/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Progressive High Intensity Therapy (PHIT) (Behavioral); Usual Care (UC) (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Self-Selected Walking Speed |
0.08; 0.08 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
6.82; 6.46 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
6.82; 6.46 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
6.82; 6.46 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
6.82; 6.46 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
6.82; 6.46 | — |
| SECONDARY Timed-Up-And-Go Test |
15.96; 16.61 | — |
| SECONDARY Timed-Up-And-Go Test |
15.96; 16.61 | — |
| SECONDARY Timed-Up-And-Go Test |
15.96; 16.61 | — |
| SECONDARY Timed-Up-And-Go Test |
15.96; 16.61 | — |
| SECONDARY Timed-Up-And-Go Test |
15.96; 16.61 | — |
| SECONDARY Modified Physical Performance Test (mPPT) |
15.49; 16.51 | — |
| SECONDARY Modified Physical Performance Test (mPPT) |
15.49; 16.51 | — |
| SECONDARY Modified Physical Performance Test (mPPT) |
15.49; 16.51 | — |
| SECONDARY Modified Physical Performance Test (mPPT) |
15.49; 16.51 | — |
| SECONDARY Modified Physical Performance Test (mPPT) |
15.49; 16.51 | — |
| SECONDARY Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor |
20.99; 19.37 | — |
| SECONDARY Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor |
20.99; 19.37 | — |
| SECONDARY Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor |
20.99; 19.37 | — |
| SECONDARY Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor |
20.99; 19.37 | — |
| SECONDARY Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor |
20.99; 19.37 | — |
| SECONDARY Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor |
19.86; 19.52 | — |
| SECONDARY Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor |
19.86; 19.52 | — |
| SECONDARY Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor |
19.86; 19.52 | — |
| SECONDARY Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor |
19.86; 19.52 | — |
| SECONDARY Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor |
19.86; 19.52 | — |
| SECONDARY Grip Strength: Dominant Hand |
26.15; 27.86 | — |
| SECONDARY Grip Strength: Dominant Hand |
26.15; 27.86 | — |
| SECONDARY Grip Strength: Dominant Hand |
26.15; 27.86 | — |
| SECONDARY Grip Strength: Dominant Hand |
26.15; 27.86 | — |
| SECONDARY Grip Strength: Dominant Hand |
26.15; 27.86 | — |
| SECONDARY Self-Selected Walking Speed |
0.63; 0.60 | — |
| SECONDARY Self-Selected Walking Speed |
0.63; 0.60 | — |
| SECONDARY Self-Selected Walking Speed |
0.63; 0.60 | — |
| SECONDARY Self-Selected Walking Speed |
0.63; 0.60 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02696382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.