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 States80 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 range65 Years
SexALL
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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 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 …