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Effects of supervised physical activity on endurance capacity in colorectal cancer patients undergoing ambulatory Chemotherapy

Effects of supervised physical activity on endurance capacity in colorectal cancer patients undergoing ambulatory Chemotherapy - CoAktiv

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005793
Enrollment
60
Registered
2014-03-11
Start date
2010-10-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C18

Interventions

Group 1: With beginning of the chemotherapy a standardized endurance training of 15/30 min will be accomplished within 24 weeks. 2 sessions per week will be passed on a bicycle ergometer (30min) and 3

Sponsors

Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin Abt. Molekulare und Zelluläre Sportmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients with curative resected colon carcinoma (UICC stadium II-III), undergoing chemotherapy for at least six months, written informed consent

Exclusion criteria

Exclusion criteria: WHO/ECOG performance status > 2, clinical manifested heart failure (NYHA III-IV), pulmonary partial and global insufficiency, diability which renders usage of an bicycle ergometer, durable thrombocytopenia < 10000/µl, congenital or acquired thrombocytopenia or coagulation disorder, pregnancy, missing consent for storage and transfer of personal data according to protocol, symtomatic Coronary disease (stress electrocardiogram recommended), therapy refractory hypertension, psychiatric disorder, uncontrolled cerebral convulsion, Psychological or medical problems which are critical in view of the responsible medical doctor

Design outcomes

Primary

MeasureTime frame
primary outcome is the physical fitness, measured by spiroergometry before and after intervention (24 weeks after baseline), and at the 3 year follow-up.

Secondary

MeasureTime frame
Quality of life (EORTC QLQ-C30 and module CR-29), measurement at baseline, 12 weeks, 24 weeks and after 3 years; reduction of frequency and intensity of treatment-related side effects; criteria of the National Cancer Institute (NCI-CTC); improvement of event-free survival, investigation of possible molecular mechanisms of physical activity: radical formation via reactive oxygene/nitrogene species (ROS / RNS), hormone status: insulin, IGF1 und IGFBP, FACS analysis for immune status, cytokine profiles: INFgamma, TNFalpha, TGFbeta, IL-1/6, MF, IL-8, flexibility of erythrocytes; blood samples will be taken at baseline, after 24 weeks and after 3 year follow up

Countries

Germany

Contacts

Public ContactFreerk Baumann

Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin Abt. Molekulare und Zelluläre Sportmedizin

f.baumann@dshs-koeln.de0221/49824821

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 14, 2026