Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-12-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Patients with cancer of the digestive system
Patients with cancer of the digestive system (oesophageal and stomach cancer) will be enrolled in this study arm.
Physical training
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
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.
Patients with cancer of the rectum
Patients with cancer of the rectum will be enrolled in this study arm.
Physical training
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
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.
Interventions
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Physical training
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Irina Chmelová, MD,PhD,MBA
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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Chmelova I, Pastucha D, Hudecek T, Guran Z, Ciecotkova S, Martinek L, Zubikova J, Matlova A, Dolezel J, Salounova D, Chmelo J. Prehabilitation during neoadjuvant therapy in patients with cancer of the upper gastrointestinal tract and rectum-the study protocol. Front Sports Act Living. 2025 Feb 3;6:1495398. doi: 10.3389/fspor.2024.1495398. eCollection 2024.
Other Identifiers
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08/RVO-FNOs/2022
Identifier Type: -
Identifier Source: org_study_id
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