N/A
N=18
Prehabilitation of Veterans With Exercise and Nutrition
Frailty
Bottom Line
View on ClinicalTrials.gov: NCT04485611 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Feasibility, Measured as Acceptance Rate — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supervised aerobic + resistance training and nutritional support (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility, Measured as Acceptance Rate |
20 | — |
| PRIMARY Acceptability, Measured as Compliance Rate |
16; 11; 12; 6 | — |
| PRIMARY Safety, Measured as the Number of Adverse Events During Exercise. |
— | — |
| SECONDARY Physical Function - Aerobic Endurance |
79.11; 105.41; 86.73; 115.38 | — |
| SECONDARY Physical Function - Lower Extremity Strength and Balance |
14.47; 9.93; 11.37; 8.85 | — |
| SECONDARY Hospital Anxiety & Depression Scale (HADS): Anxiety (HADS-A) |
5.21; 4.23; 4.21; 2.92; 4.21 | — |
| SECONDARY Hospital Anxiety & Depression Scale (HADS): Depression (HADS-D) |
3.16; 2.71; 3.57; 1.77; 3.57 | — |
| SECONDARY Short Form 36 (SF-36) |
69.04; 74.60; 68.21 | — |
Summary
The goal of VA's RR&D office is to maximize functional recovery. This proposal will allow the investigators to test an intervention that combines the fundamentals of Physical Medicine and Rehabilitation with state-of-the-art nutritional support and innovations in care such as telehealth and the use of activity trackers to optimize patients before high-risk surgery. This intervention has the potential to not only reduce complications and hospital readmissions, but also to maximize functional recovery and quality of life for thousands of Veterans undergoing high-risk surgery every year. Furthermore, the proposal is the first step in the design and implementation of prehabilitative services for Veterans living in rural areas and those with inadequate support or transportation.
Eligibility Criteria
Inclusion Criteria
- Scheduled for high-risk surgery
- Time from assessment to surgery 21 days
- Age 50 years
- English speaking
- 5RSTS time >11 sec and/or TMST score 25% percentile for gender/age
Exclusion Criteria
- A score of <21 (high school) or <20 (less than high school) on the Montreal Cognitive Assessment (MoCA)
- Dementia diagnosis
- Inability to complete physical function assessment
- ASA categories 4 and 5
- Living in skilled nursing facility
- No access to a telephone
- Advanced chronic kidney disease (KDIGO stage 4 and 5)
Data sourced from ClinicalTrials.gov (NCT04485611). 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.