Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail… (NCT06874413) | Clinical Trial Compass
By InvitationNot Applicable
Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
United States120 participantsStarted 2025-03-19
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* U…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.