---
title: PREHAB - Improving Condition Before Surgery
nct_id: NCT05646043
overall_status: UNKNOWN
phase: NA
sponsor: University Hospital Ostrava
study_type: INTERVENTIONAL
primary_condition: Cancer, Digestive System
countries: Czechia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05646043.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05646043"
ct_last_update_post_date: 2024-01-18
last_seen_at: "2026-05-12T06:46:57.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# PREHAB - Improving Condition Before Surgery

**Official Title:** PREHABILITATION During Neoadjuvant Therapy in Patients With Cancer of the Upper Digestive Tract and Rectum

**NCT ID:** [NCT05646043](https://clinicaltrials.gov/study/NCT05646043)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** University Hospital Ostrava
- **Conditions:** Cancer, Digestive System, Cancer, Rectum
- **Start Date:** 2022-12-01
- **Completion Date:** 2025-12
- **CT.gov Last Update:** 2024-01-18

## Brief Summary

The pilot research project is focused on the feasibility of a prehabilitation program for two groups of diagnoses (esophageal and stomach cancer, rectal cancer).

## Detailed Description

With the aim of achieving downstaging, downsizing, and reducing the risk of recurrence, neoadjuvant chemotherapy, possibly chemoradiotherapy - i.e. neoadjuvant therapy is indicated in the preoperative period for patients with cancer of the upper digestive tract and rectal cancer.

Chemotherapy has a negative impact not only on the overall physical and mental condition of the patient but also on the quality of life and on the daily activities of the individual, especially in the period when the organism is facing an abnormal stress load in the sense of extensive surgical procedures.

Recently, attention and efforts to improve postoperative morbidity and mortality have increasingly focused on the preoperative period. The concept of prehabilitation, which is defined as an intervention improving functional capacity before an upcoming physiological stressor, appears as a way to contribute to this. This fact is evidenced by a number of published references.

The main aim of the study is to confirm or refute the feasibility of the prehabilitation program during neoadjuvant therapy in two diagnostic groups of patients:

* \- Patients with cancer of the upper digestive tract
* \- Patients with rectal cancer

The prehabilitation program will be implemented in the patient's home environment.

The study aims to answer the basic research question of whether selected patients will be able to complete a home exercise regimen during the preoperative period when they will undergo neoadjuvant therapy.

As part of the study, the program's security and feasibility will be tested.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* radically operable locally advanced cancer of the esophagus, esophagogastric junction, stomach
* radically operable locally advanced carcinoma of the rectum
* the patient is able to handle the planned surgical resection procedure
* planned preoperative neoadjuvant therapy
* age \> 18 years
* the ability to complete a spiroergometric examination
* the ability to carry out a prehabilitation program consent to participate in the study confirmed by signing the informed consent

Exclusion Criteria:

* contraindications for spiroergometric examination
* limitation on the part of the locomotor system to spiroergometric examination or daily exercise (e.g. amputation, severe gonarthrosis, coxarthrosis)
* inoperability determined by the interdisciplinary team
* inability to manage the planned operational performance
* acute surgical performance
* synchronous malignant disease
* multivisceral resection
* planned non-surgical therapeutic procedure
* incomplete data
```

## Arms

- **Patients with cancer of the digestive system** (ACTIVE_COMPARATOR) — Patients with cancer of the digestive system (oesophageal and stomach cancer) will be enrolled in this study arm.
- **Patients with cancer of the rectum** (ACTIVE_COMPARATOR) — Patients with cancer of the rectum will be enrolled in this study arm.

## Interventions

- **Physical training** (BEHAVIORAL) — Physical training consists of endurance walking and strength training. The basis for determining the number of steps per day is the baseline value of each patient. This will increase by 10-15% every week until the surgery date. The assumption of a total load increase is 120-180% compared to the baseline.
- **Muscle strength training** (BEHAVIORAL) — Muscle strength training will take place using exercises to strengthen the upper and lower limbs and to strengthen the trunk. There will be a set of 5 exercises in two difficulty variants. The study subjects will perform this set 7 days a week, and will repeat the assembly a total of two times. The total time of strength training is 10 min.

## Primary Outcomes

- **Number of enrolled patients** _(time frame: 3 months)_ — The number of patients who express an interest in being included in the study from all patients diagnosed and indicated for neoadjuvant therapy in the monitored period. the reasons for refusal to enroll in the study will be monitored.
- **Number of patients completing the program** _(time frame: 3 months)_ — The number of patients who complete the prehabilitation program by the time of surgery.
- **Individual patient compliance** _(time frame: 3 months)_ — Number of days when the patient wore the smart bracelet and performed or attempted to perform the exercise program out of the total number of days in the monitored period

## Secondary Outcomes

- **Changes in spirometry examination results** _(time frame: 3 months)_
- **Changes in the quality of life** _(time frame: 3 months)_
- **Parameters monitored by the oncologist** _(time frame: 3 months)_
- **Exercise program - number of steps/day** _(time frame: 3 months)_
- **Exercise program - pressing force on the dynamometer** _(time frame: 3 months)_
- **Exercise program - InBody examination** _(time frame: 3 months)_
- **Exercise program - Body Mass Index** _(time frame: 3 months)_
- **Exercise program - perceived exertion** _(time frame: 3 months)_
- **Parameters monitored by the anesthesiologist - ASA value** _(time frame: 3 months)_
- **Parameters monitored by the anesthesiologist - morbidity assessment** _(time frame: 3 months)_
- **Parameters monitored by the anesthesiologist - preoperative analgesia** _(time frame: 3 months)_
- **Parameters monitored by the anesthesiologist - postoperative opioid analgesia** _(time frame: 3 months)_
- **Parameters monitored by the anesthesiologist - pain assessment** _(time frame: 3 months)_
- **Laboratory examinations - complete blood count** _(time frame: 3 months)_
- **Laboratory examinations - CRP values** _(time frame: 3 months)_
- **Laboratory examinations - procalcitonin level** _(time frame: 3 months)_
- **Laboratory examinations - nutritional parameters** _(time frame: 3 months)_
- **Laboratory examinations - coagulation factors (aPTTp** _(time frame: 3 months)_
- **Laboratory examinations - coagulation factors (fibrinogen)** _(time frame: 3 months)_

## Locations (1)

- University Hospital Ostrava, Ostrava, Moravian-Silesian Region, Czechia — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university hospital ostrava|ostrava|moravian-silesian region|czechia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05646043.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05646043*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*