Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prehabilitation, Standard of Care (SOC).
- Who it may be relevant to
- Registry conditions: Frailty, Ventral Hernia. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Prehabilitation
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. - Other Standard of Care (SOC)
Patients will receive standard of care preoperative instructions.
Primary outcome measures
- Activity levels [Time frame: 6-8 weeks preoperatively]
Secondary outcome measures (7)
- Quality of Life Pre- and Postoperative Assessment [Time frame: 14-30 days postoperatively]
- Quality of Life Pre- and Postoperative Outcomes [Time frame: 14-30 days postoperatively]
- Quality of Life Pre- and Postoperative Outcomes [Time frame: 14-30 days postoperatively]
- Postoperative Outcomes - Surgical Complications [Time frame: 14-30 days postoperatively]
- Postoperative Outcomes - Length of Stay [Time frame: 14-30 days postoperatively]
- Postoperative Outcomes - Discharge Location [Time frame: 14-30 days postoperatively]
- Postoperative Outcomes - Return to Baseline [Time frame: 14-30 days postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Prisma Health — Greenville
Identifiers
NCT: NCT06874413 · 2290314