|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
1 July 2019 |
|
Main ID: |
ISRCTN10827174 |
|
Date of registration:
|
16/11/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The role of exercise in metabolism and quality of life after pancreatectomy
|
|
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 |
|
Date of first enrolment:
|
30/05/2014 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN10827174 |
|
Study type:
|
Interventional |
|
Study design:
|
Interventional single-centre,randomized controlled trial (Quality of life)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Greece
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Anastasios
Katsourakis |
|
Address:
|
2 Elenis Zografou str
GR- 54634
Thessaloniki
Greece |
|
Telephone:
|
+30 2313 322 178 |
|
Email:
|
tasoskatsourakis@hotmail.com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Adult patients with pancreatic neoplasms that are fit for surgery
Exclusion criteria:
1. Age >75 years old
2. ASA >2
3. Non resectable pancreatic tumor (according to the guidelines)
4. Pregnancy
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Pancreatic disease, mainly neoplastic tumors of the pancreas
Cancer
|
|
Intervention(s)
|
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(s)
|
|
Measurement of blood glucose levels, HBA1c, albumin and uric acid, 12 weeks after the initiation of exercise (once every 4 weeks interval)
|
|
Secondary Outcome(s)
|
|
Evaluation of the quality of life (QoL) in both groups 12 weeks after the initiation of exercise
|
|
Secondary ID(s)
|
|
02/pancreas/05.2014
|
|
Source(s) of Monetary Support
|
|
Agios Dimitrios General Hospital
|
|
Ethics review
|
Status:
Approval date:
Contact:
Bioethics committee and Deontology, Medical School of Aristotle University Thessaloniki, 29/10/2015, ref: 166/ 29.10.2015
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
30/06/2016 |
|
URL:
|
|
|
|