Feasibility of a 4-Week Intensive Postoperative Multimodal Rehabilitation Program in Complicated Patients After Proximal Pancreatectomy: A Prospective Single-Cohort Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Multimodal Postoperative Rehabilitation Program: Participants will undergo a 4-week multimodal postoperative rehabilitation program starting during the first week after hospital discharge. The program includes individualized exercise training, nutritional therapy, and anxiety-reducing techniques. Exercise includes moderate-intensity endurance, resistance, and breathing exercises tailored to the patient's clinical condition and may be delivered in a hospital-based or home-based setting. Nutritional therapy consists of an individualized dietary plan, with a recommended protein intake of 1.5-2.0 g/kg of ideal body weight and whey protein supplementation if needed. Participants will also receive instruction in relaxation techniques, including imagery, visualization, and deep-breathing exercises. The program is delivered by qualified physiotherapists, nutritionists, and psychology-trained personnel.

Study summary

The REACT study is a prospective, single-center, single-cohort study designed to evaluate the feasibility of a 4-week intensive multimodal postoperative rehabilitation program in patients who develop severe complications after proximal pancreatic resection (pancreatoduodenectomy or total pancreatectomy).

Postoperative complications after pancreatic surgery may result in substantial physiological and metabolic stress, leading to loss of muscle mass, malnutrition, reduced functional capacity, and delayed recovery. Although prehabilitation programs have been proposed to improve patients' functional capacity before surgery, evidence regarding structured multimodal rehabilitation after pancreatic surgery is currently lacking.

Adult patients undergoing elective proximal pancreatic resection who develop a severe postoperative complication (Comprehensive Complication Index \>21) will be eligible for the study. Participants will undergo a 4-week multimodal rehabilitation program starting after hospital discharge and including individualized exercise training, nutritional therapy, and anxiety-reducing techniques. The program may be delivered either in a supervised hospital-based setting or through a home-based program according to patient preference and availability.

The primary objective is to assess the feasibility of the rehabilitation program in terms of recruitment, adherence, completion of outcome assessments, completeness of data, and safety. Secondary objectives include evaluating postoperative functional recovery using PROMIS-29 Physical and Mental Health Summary Scores, the 6-minute walk test, and the Duke Activity Status Index. In patients with malignancy who are candidates for adjuvant treatment, return to intended oncologic treatment will also be evaluated.

A total of 40 patients will be enrolled and followed for up to 90 days after surgery.

Eligibility

Primary outcome measure(s)

• Feasibility of the multimodal postoperative rehabilitation program — At the end of the 4-week rehabilitation program
  Feasibility will be assessed according to five predefined criteria: 1. ≥50% of eligible patients agree to participate; 2. ≥80% of enrolled patients adhere to the program; 3. ≥80% complete the post-rehabilitation outcome assessment; 4. missing data among patients completing outcome assessments are \<10%; (5) no serious adverse events related to the rehabilitation program occur. The intervention will be considered feasible only if all five criteria are met.

Trial sites (1)

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