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
tasoskatsourakis@hotmail.com
Study website
Contact information
Type
Scientific
Contact name
Dr Anastasios Katsourakis
ORCID ID
http://orcid.org/0000-0002-5151-9449
Contact details
2 Elenis Zografou str
Thessaloniki
GR- 54634
Greece
+30 2313 322 178
tasoskatsourakis@hotmail.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
02/pancreas/05.2014
Study information
Scientific title
The influence of exercise on blood glucose control and the anti-oxidative ability of the blood in patients after pancreatectomy: a randomized controlled trial
Acronym
EQAP (Exercise and Quality of life After Pancreatectomy)
Study hypothesis
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.
Ethics approval(s)
Bioethics committee and Deontology, Medical School of Aristotle University Thessaloniki, 29/10/2015, ref: 166/ 29.10.2015
Study design
Interventional single-centre,randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Pancreatic disease, mainly neoplastic tumors of the pancreas
Intervention
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.
Intervention type
Mixed
Primary outcome measure
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 study start date
28/05/2014
Overall study end date
30/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult patients with pancreatic neoplasms that are fit for surgery
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
40 patients
Total final enrolment
43
Participant exclusion criteria
1. Age >75 years old
2. ASA >2
3. Non resectable pancreatic tumor (according to the guidelines)
4. Pregnancy
Recruitment start date
30/05/2014
Recruitment end date
30/06/2016
Locations
Countries of recruitment
Greece
Study participating centre
Agios Dimitrios General Hospital of Greece
2 Elenis Zografou Street
Thessaloniki
GR-54634
Greece
Sponsor information
Organisation
Agios Dimitrios General Hospital scientific committee and Aristotle University Thessaloniki
Sponsor details
2 Elenis Zografou str
Thessaloniki
GR-54634
Greece
+30 2313 322 100/178
tasoskatsourakis@hotmail.com
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Agios Dimitrios General Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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.
Intention to publish date
01/11/2017
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Tasos Katsourakis (tasoskatsourakis@hotmail.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.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2019 | 11/01/2019 | Yes | No |
| Results article | results | 01/01/2020 | 10/06/2019 | Yes | No |