Frailty, Ventral Hernia
Conditions
Brief summary
The purpose of this study is to assess the physical fitness of patients undergoing hernia repair and correlate the postoperative outcomes and recovery as well as assess the impact of a targeted physical exercise program preoperatively in a cohort of frail, elderly patients. The investigators hypothesize that physical exercise will improve activity levels in elderly patients with frailty prior to ventral hernia repair. The investigators further hypothesize that increased levels of activity preoperatively will correlate with improved postoperative outcomes.
Detailed description
The goals of this study are to: * assess the impact of a targeted physical exercise program on activity levels prior to ventral hernia repair in elderly, frail patients using wearable activity monitoring. * correlate physical activity and the impact of physical exercise with postoperative outcomes, including quality of life, postoperative complications, length of hospital stay, discharge to home, and return to baseline activity. The investigators intend to randomize one group of elderly, frail patients to perform an exercise program for 6-8 weeks prior to surgery and another group of elderly, frail patients to receive standard of care preoperative instructions. The investigators will also collect data from a cohort of patients receiving a ventral or inguinal hernia repair who have a wearable activity monitor that are willing to download an application on their phone and allow us to monitor their activity levels prior to surgery.
Interventions
BEHAVIORALPrehabilitation
Physical prehabilitation or exercise conducted through the YMCA's Silver Sneaker's program prior to receiving surgery that will be assessed through the use of wearable activity monitors.
OTHERStandard of Care (SOC)
Patients will receive standard of care preoperative instructions.
Sponsors
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Groups 1 \& 2: * Age 65 or greater * Presence of a ventral hernia with plans for elective hernia repair with mesh * Willing to consent to study and randomization, including activity data capture * Score of ≥6 and ≤11 on the Edmonton Frail Scale OR 5-item modified Frail Index Score \> 0 * For patients with cardiac disease, additional referral for cardiac risk assessment may be performed at the discretion of the treating surgeon or anesthesiologist. If deemed appropriate risk, patients may still enroll. * Uses a smartphone that is capable of downloading the Health Kit application * Group 3: * Age 18 or older * Presence of a ventral hernia or inguinal hernia with plans for elective repair with mesh * Willing to consent to activity data capture * Uses a smartphone that is capable of downloading the Health Kit application
Exclusion criteria
* Group 1 \&2: * Age \<65 * Unwilling or unable to consent to study or randomization * Joint or muscle pain with movement at a level of 5 out of 10 or higher per patient report * Score of ≥12 on Edmonton Frail Scale * mFI-5 positive for congestive heart failure (newly diagnosed or exacerbated within 30 days) * Functional dependence that prevents self-guided physical prehabilitation or other condition medically unsuitable for exercises (as determined by surgeon). * BMI \>50 * Parastomal hernia repair or repair without mesh * Plan for concurrent procedure Group 3: * \<18 y/o * Unwilling or unable to consent to study * Joint or muscle pain with movement at a level of 5 out of 10 or higher per patient report * BMI \>50 * Parastomal hernia repair or repair without mesh * Plan for concurrent procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity levels | 6-8 weeks preoperatively | Amount of time spent active measured by data from wearable activity monitors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Pre- and Postoperative Assessment | 14-30 days postoperatively | Quality of life will be measured with the Hernia-Related Quality of Life Survey (HerQLes). This survey is a 12 question survey that measures how strongly the patient agrees or disagrees (strongly, moderately, and slightly agree or disagree) with the statement. |
| Quality of Life Pre- and Postoperative Outcomes | 14-30 days postoperatively | Quality of life as measured by the Patient-Reported Outcome Measurement Information System (PROMIS-3). |
| Postoperative Outcomes - Surgical Complications | 14-30 days postoperatively | Postoperative complications |
| Postoperative Outcomes - Length of Stay | 14-30 days postoperatively | Number of days staying in the hospital prior to discharge |
| Postoperative Outcomes - Discharge Location | 14-30 days postoperatively | Discharge location |
| Postoperative Outcomes - Return to Baseline | 14-30 days postoperatively | Ability to return to baseline activity |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeremy Warren, MD
Prisma Health
Outcome results
None listed