Clinical trial · Interventional
Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer.
Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer. A Phase II Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with gastrointestinal cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal surgical procedures. It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention. Main objective: To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery. Materials and methods: This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, hepatic, colon or rectal cancer), without electrocardiographic abnormalities, and scheduled for primary surgery in 4 weeks or more since recruitment All the enrolled patients will receive a basal aerobic capacity assessment with the 6-minute walk test. Then, two physical therapist will prescribe them a supervised and individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will increase the heart rate target weekly (from 50% to 70% of the maximum heart rate). The aerobic exercise will be carried on a treadmill or in a stationary bicycle. The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence. This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Liver Neoplasm | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative exercise program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preoperative exercise program
- description
- The individualized aerobic training program will be developed according to Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks. Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed as follows: Week 1: heart rate target: 50% of maximum heart rate Week 2: heart rate target: 60% of maximum heart rate Week 3: heart rate target: 70% of maximum heart rate Week 4: heart rate target: 60% of maximum heart rate The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist.
- interventionNames
- Other: Preoperative exercise program
Primary outcomes (1)
- measure
- Peak oxygen comsumption
- timeFrame
- 4 weeks after the exercise program beginning
- description
- peak oxygen consumption measured in ml/kg/min using the American College of Sports Medicine's equation
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion criteria: * 45 to 70 years * Confirmed diagnosis of gastric, hepatic, colon or rectal cancer. * Live in Bogota for at least 3 months * Hemoglobin concentration superior to 10g/dL * Primary surgery date scheduled in the next 4 weeks or more since eligibility assessment * ECOG score 0 or 1 Exclusion criteria: * Behavior or cognitive impairment * musculoskeletal impairment * any exercise contraindication (fracture or sprains in the last 2 months, severe osteoarthritis, tendinitis) * Uncontrolled metabolically comorbidities (diabetes, hypertension, hyperlipidemia) * Presence of obstructive or restrictive pulmonary disease * Enrolled in another supervised exercise program * Major electrocardiographic abnormalities.
References
Publications (27)
- BACKGROUNDPardo C, Cendales R. Incidencia, prevalencia y mortalidad de Cáncer en Colombia, 2007-2011: Instituto Nacional de Cancerología; 2015.
- BACKGROUNDChicharro, JL., Vaquero, AF. (2006). Fisiología del ejercicio. Ed. Médica Panamericana.
- BACKGROUNDSchmidt K, Vogt L, Thiel C, Jager E, Banzer W. Validity of the six-minute walk test in cancer patients. Int J Sports Med. 2013 Jul;34(7):631-6. doi: 10.1055/s-0032-1323746. Epub 2013 Feb 26. PMID 23444095
- RESULTVeen EJ, Steenbruggen J, Roukema JA. Classifying surgical complications: a critical appraisal. Arch Surg. 2005 Nov;140(11):1078-83. doi: 10.1001/archsurg.140.11.1078. PMID 16301444
- RESULTWorster B, Holmes S. A phenomenological study of the postoperative experiences of patients undergoing surgery for colorectal cancer. Eur J Oncol Nurs. 2009 Dec;13(5):315-22. doi: 10.1016/j.ejon.2009.04.008. Epub 2009 May 30. PMID 19482512
- RESULTDindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. PMID 15273542
- RESULTMartos-Benitez FD, Gutierrez-Noyola A, Echevarria-Victores A. Postoperative complications and clinical outcomes among patients undergoing thoracic and gastrointestinal cancer surgery: A prospective cohort study. Rev Bras Ter Intensiva. 2016 Jan-Mar;28(1):40-8. doi: 10.5935/0103-507X.20160012. PMID 27096675
- RESULTWilson RJ, Davies S, Yates D, Redman J, Stone M. Impaired functional capacity is associated with all-cause mortality after major elective intra-abdominal surgery. Br J Anaesth. 2010 Sep;105(3):297-303. doi: 10.1093/bja/aeq128. Epub 2010 Jun 23. PMID 20573634