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Prehabilitation for Gastrectomy

Personalized Trimodal Prehabilitation for Gastrectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04223401
Acronym
PREFOG
Enrollment
128
Registered
2020-01-10
Start date
2020-02-06
Completion date
2023-12-31
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Brief summary

Prehabilitation has been demonstrated to be an effective strategy to improve outcomes in patients undergoing some of the abdominal operations. It may increase the physical capacity of the patient, improve postoperative quality of life and even decrease the postoperative morbidity. Currently, the most effective strategy seems to be a trimodal prehabilitation which includes: 1) Nutritional support 2) Psychological support and 3) Physical training.

Detailed description

This study will investigate personalized trimodal prehabilitation for patients undergoing gastrectomy for gastric cancer. Prehabilitation group: Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve: 1. Nutritional intervention: The dietetic physician will perform physical examination and evaluation of the nutritional status to provide individualized care to each patient. Patients will receive personalized recommendations for the prevention or correction of malnutrition. 2. Psychological intervention: Patients will undergo consultation by specialized onco-psychologist. The anxiety and depression level will be evaluated by HAD score and patients will be trained to perform techniques, such as relaxation to reduce and manage anxiety on at home basis. The psychologist also will enhance patients' motivation to comply with the exercise and nutritional aspects of the intervention. 3. Exercise intervention: Patients will be consulted by PM&R physicians and physiotherapists and personalized exercise plans will be developed according to the results of 6MWT, AT and VO2peak. Exercises will focus on skeletal muscles and cardiopulmonary function training and the exercises feasible at home basis will be selected. All patients will undergo three supervised training sessions to learn the correct exercise techniques. All patients will be routinely contacted to ensure compliance with prehabilitation program. Patients scheduled for surgery first by multidisciplinary tumor board will undergo 4 weeks prehabilitation program, while patients scheduled for perioperative chemotherapy will undergo prehabilitation while neoadjuvant treatment will be administered. Control group: Patients will also undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before surgery or before and after neoadjuvant chemotherapy. Patients will not undergo prehabilitation.

Interventions

OTHERPrehabilitation

Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve: 1. Nutritional intervention 2. Psychological intervention 3. Exercise intervention

Sponsors

Vilnius University
CollaboratorOTHER
Vilnius University Hospital Santaros Klinikos
CollaboratorOTHER
National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient ≥ 18 years old * Patient agrees to participate in a clinical study * Patient requires surgical treatment for gastric cancer

Exclusion criteria

* Patient requiring surgical treatment for recurrent gastric cancer * Patient condition not allowing to postpone surgery for at least 4 weeks * Patients physical or mental condition which will not allow the patient to participate in prehabilitation program

Design outcomes

Primary

MeasureTime frame
Postoperative morbidity rate by Clavien-DindoAt 90 days postoperatively

Secondary

MeasureTime frame
Physical status by the sit to stand testBaseline, pre-surgery, 3, 6 and 12 months after surgery
Physical status by the timed up&go testBaseline, pre-surgery, 3, 6 and 12 months after surgery
Psychological status by Hospital Anxiety and Depression Scale (HADS).Baseline, pre-surgery, 3, 6 and 12 months after surgery
Physical status by SpiroergometryBaseline, pre-surgery, 3, 6 and 12 months after surgery
Physical status by International Physical Activity Questionnaire (IPAQ)Baseline, pre-surgery, 3, 6 and 12 months after surgery
Physical status by 6 minutes walk testBaseline, pre-surgery, 3, 6 and 12 months after surgery
Nutritional status by albumin levelBaseline, pre-surgery, 3, 6 and 12 months after surgery
Quality of Life by EORTC questionnairesBaseline, pre-surgery, 3, 6 and 12 months after surgery
Percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board (including preoperative chemotherapy, surgery and postoperative chemotherapy)12 months after surgery
Physical status by grip strength testBaseline, pre-surgery, 3, 6 and 12 months after surgery
Postoperative mortality rateAt 30 and 90 days postoperatively

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026