Plain English Summary
Background and study aims
There are no studies that provide sufficient information on how exercise can influence the quality of patient’s life after resection (removal) of the pancreas due to pancreatic disease, such as cancer. The aim of this study is to find out whether exercise can help in controlling blood glucose levels and oxidative stress after pancreatectomy (surgery to remove the pancreas).
Who can participate?
Adult patients with pancreatic cancer that are fit for surgery.
What does the study involve?
The participants are randomly allocated into one of two groups. All participants have a pancreatectomy. The participants in the exercise group exercise using a static bicycle for 12 weeks. The participants in the control group do not exercise. Blood glucose, HBA1c (glycated haemoglobin, which is a form of haemoglobin that is measured to identify average plasma glucose concentrations in the blood), albumin and the uric acid levels for all participants in both groups are measured every 4 weeks for the duration of the study.
What are the possible benefits and risks of participating?
There are no risks for the participants.
Where is the study run from?
Agios Dimitrios General Hospital (under the control of Aristotle University Thessaloniki)
When is study starting and how long is it expected to run for?
May 2014 to June 2016
Who is funding the study?
Agios Dimitrios General Hospital (Greece)
Who is the main contact?
Dr Anastasios Katsourakis
The influence of exercise on blood glucose control and the anti-oxidative ability of the blood in patients after pancreatectomy: a randomized controlled trial
EQAP (Exercise and Quality of life After Pancreatectomy)
The aim of this study is to investigate whether pancreatectomy helps to control blood glucose after exercise, improves the anti-oxidative ability of the blood in patients and improves patient quality of life.
Bioethics committee and Deontology, Medical School of Aristotle University Thessaloniki, 29/10/2015, ref: 166/ 29.10.2015
Interventional single-centre,randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Pancreatic disease, mainly neoplastic tumors of the pancreas
Participants are randomly allocated to one of two groups, the intervention group and the control group.
Both groups will undergo a pancreatectomy. The surgical procedure will be open and according to the location of the tumor the patient will undergo a Longmire Traverso/Whipple operation (pancreatoduodenectomy) or distal pancreatectomy with or without preservation of the spleen. Four weeks after the operation the participants in the intervention group will start to exercise, which involves 30 minutes on a static bicycle (60% of maximum heart rate) for 12 weeks. The participants in the control group do not start to exercise.
Primary outcome measures
Measurement of blood glucose levels, HBA1c, albumin and uric acid, 12 weeks after the initiation of exercise (once every 4 weeks interval)
Secondary outcome measures
Evaluation of the quality of life (QoL) in both groups 12 weeks after the initiation of exercise
Overall trial start date
Overall trial end date
Participant inclusion criteria
Adult patients with pancreatic neoplasms that are fit for surgery
Target number of participants
Participant exclusion criteria
1. Age >75 years old
2. ASA >2
3. Non resectable pancreatic tumor (according to the guidelines)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Agios Dimitrios General Hospital of Greece
2 Elenis Zografou Street
Agios Dimitrios General Hospital scientific committee and Aristotle University Thessaloniki
2 Elenis Zografou str
+30 2313 322 100/178
Agios Dimitrios General Hospital
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The trialists intend to publish the results immediately after the recruitment of a statistically significant number of patients and about 2 weeks later after the statistical analysis.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Tasos Katsourakis (email@example.com). Type of data that will be shared: all data will be available. When the data will be available: starting 01/10/2017. For how long: no limit. What type of analyses: demographic and surgical details, repeated measures ANOVA for the results. Consent was obtained from all participants, no ethical or legal restrictions.
Intention to publish date
Participant level data
Available on request
Results - basic reporting