PREHAB - Improving Condition Before Surgery

NCT05646043 | Unknown

• 1 other identifier: 08/RVO-FNOs/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer, Digestive System; Cancer, Rectum

Keywords

prehabilitation; cancer of the digestive system; cancer of the rectum; endurance walking; power training

Outcome Measures

Primary Outcomes (3)

• Number of enrolled patients

  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.

  3 months

• Number of patients completing the program

  The number of patients who complete the prehabilitation program by the time of surgery.

  3 months

• Individual patient compliance

  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

  3 months

Secondary Outcomes (19)

• Changes in spirometry examination results

  3 months

• Changes in the quality of life

  3 months

• Parameters monitored by the oncologist

  3 months

• Exercise program - number of steps/day

  3 months

• Exercise program - pressing force on the dynamometer

  3 months

Study Arms (2)

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.

Behavioral: Physical training; Behavioral: Muscle strength training

Patients with cancer of the rectum

ACTIVE COMPARATOR

Patients with cancer of the rectum will be enrolled in this study arm.

Behavioral: Physical training; Behavioral: Muscle strength training

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.

Patients with cancer of the digestive system; Patients with cancer of the rectum

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.

Patients with cancer of the digestive system; Patients with cancer of the rectum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

RECRUITING

Related Publications (1)

• 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.

  PMID: 39963182 DERIVED

MeSH Terms

Conditions

Digestive System Neoplasms; Rectal Neoplasms

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Irina Chmelová, MD,PhD,MBA

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking is used in this study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be enrolled in two parallel groups.

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 12, 2022
• Study Start: December 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)