Exercise & Training

STRONG prehabilitation before elective ventral hernia repair: Learnings from recruitment challenges in a randomized controlled trial.

TL;DR

The STRONG-Hernia trial was terminated early after randomizing only 43 of a planned 398 patients, so it was not powered to assess postoperative complications; the STRONG program 'seems promising for optimizing risky lifestyles', though these results are preliminary.

Key Findings

The trial recruited far fewer patients than planned and was terminated early because of slow recruitment.

  • Power calculation required inclusion of 2 × 199 patients.
  • Between March 2024 and May 2025, 43 patients were randomized: 21 to STRONG prehabilitation and 22 to standard care.
  • The trial was therefore not powered to assess the effect of prehabilitation on postoperative complications.

Most participants had one risky lifestyle factor, and obesity was the most common.

  • Around 75% had one risky SNAP (smoking, nutrition, alcohol, physical inactivity) factor.
  • About 25% had ≥2 risky factors.

Prehabilitation led to a much higher proportion of participants with all risky lifestyles optimized at end of intervention.

  • 13/19 in the prehabilitation group had optimized all risky lifestyles versus 0/22 in the control group (p < 0.01).
  • Two prehabilitation participants were excluded shortly after randomization because they had no surgery.
  • The authors describe these lifestyle results as preliminary.

Postoperative complications at 30 days did not differ significantly between groups, but the trial was underpowered.

  • Complications occurred in 3/16 prehabilitation and 4/19 control participants (p = 1.00).
  • Three additional participants in each group did not undergo surgery.
  • The trial was not powered to assess complications.

EQ-5D VAS stayed unchanged with prehabilitation but decreased in controls, while EQ-5D-5L index changes were similar between groups.

  • EQ-5D VAS remained unchanged from baseline in the prehabilitation group but decreased significantly in the control group (p = 0.03).
  • EQ-5D-5L index changes were similar between groups (p = 0.92).

Recruitment challenges included patient outsourcing, an insufficient recruitment strategy, and a low inclusion rate.

  • The authors suggest insights from the trial may help address recruitment challenges in a future adequately powered trial.
  • The intervention comprised six weekly in-hospital sessions of education, motivational, and pharmaceutical support tailored to each patient's SNAP factors.

The study was a multicenter, parallel-group, centrally randomized trial with blinded final outcome assessment and analyses.

  • Conducted at two Danish university hospitals (NCT06611462).
  • Adults scheduled for elective ventral hernia repair with ≥1 risky SNAP factor were randomized 1:1 to STRONG prehabilitation or standard care.
  • Primary outcome was postoperative complications ≤30 days; secondary outcomes included lifestyle changes and EQ-5D.

What This Means

This study tested whether a six-week program of weekly hospital sessions could help people with unhealthy lifestyle habits (smoking, poor nutrition including obesity, risky alcohol use, or physical inactivity) get healthier before planned hernia surgery, and whether this would reduce complications afterward. Patients were randomly assigned to the program or to usual care. The trial planned to enroll nearly 400 patients but managed only 43 before being stopped early, mainly because of recruitment problems such as patients being sent elsewhere for surgery and a recruitment approach that was not effective enough. Among those who completed the program, most (13 of 19) had improved all of their risky habits, compared with none of 22 in the usual-care group. Complication rates after surgery were similar (3 of 16 versus 4 of 19), but with so few patients this trial could not determine whether the program affects complications. Self-rated health stayed stable in the program group but fell in the usual-care group. This research suggests that the program may help people change risky lifestyle habits before surgery, but these findings are preliminary. The main contribution is a clearer picture of recruitment pitfalls, which could help researchers design a larger trial that can properly test whether such programs reduce surgical complications.

Check Your Own Numbers

Upload your bloodwork. We'll cross-reference your results against this study and 4,700 others.

Upload Your Labs

Have a question about this study?

Citation

Jensen S, Lauridsen S, Fonnes S, Rosenberg J, Brandstrup B, Helgstrand F, et al.. (2026). STRONG prehabilitation before elective ventral hernia repair: Learnings from recruitment challenges in a randomized controlled trial.. PloS one. https://doi.org/10.1371/journal.pone.0360482