Preoperative exercise training to increase the postoperative, functional capacity of patients with diverticulitis und colon cancer- a randomised controlled study

Phase 3

Recruiting

• Conditions: K57; C18; Diverticular disease of intestine; Malignant neoplasm of colon

• Registration Number: DRKS00028751
• Lead Sponsor: Abteilung Leistung und Gesundheit (Sportmedizin)Institut für Sport und SportwissenschaftTechnische Universität DortmundOtto-Hahn-Straße 3, 44227 Dortmund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Diagnosis of acute or chronic diverticulitis or colon cancer
- Candidate for elective colorectal surgery
- Schedule of surgery that allows intervention of more than three to five weeks prior to surgery
- High risk for surgical complications, defined by the presence of concomitant diseases such as deconditioning, heart disease, diabetes, renal insufficiency, hypertension or severe obesity (BMI=30)
- German language skills that allow understanding of the questionnaires and the tasks during testing and the sports intervention

Exclusion Criteria

Non-elective surgery
Unstable heart or respiratory disease
Limitations in mobility that prevent the intended exercise training
Cognitive limitations that prevent participation in the programme
Participation in other research studies that affect the endpoint of the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endurance capacity measured by 6 Minute Walking Test at t0, t1, t3, t4 and t5

Secondary Outcome Measures

Name	Time	Method
Peak oxygen uptake (VO2peak) reflecting their cardiorespiratory fitness measured during a maximal incremental exercise test on a cycle ergometer (t0, t1, t4 and t5)<br><br>Strength capacity measured by the Five-Repetition Maximum strength in relevant muscle groups (0, t1, t4 and t5) and by the hand grip strength (t0, t1, t3, t4 and t5)<br><br>body composition measured by a bioimpedance analysis (t0, t1, t4 and t5)<br><br>clincal, patient- oriented outcomes, i.e. days at home after 30, 60 and 90 days post surgery, time of intensive care needed, postoperative complicationes, return to work (t3, t4 and t5)<br><br>questionnaires to measure sleeping quality (t0, t1, t4 and t5) and quality of life (t0, t1, t4 and t5) <br><br>Number and proportions of further circulating immune markers associated with inflammation and exercise (t0, t1, t2, t3, t4 and t5)<br><br>Systemic and local, humoral and cellular inflammatory markers in blood, visceral fat and intestinal tissue (t2)