The role of exercise in metabolism and quality of life after pancreatectomy
| ISRCTN | ISRCTN10827174 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10827174 |
| Secondary identifying numbers | 02/pancreas/05.2014 |
- Submission date
- 03/11/2015
- Registration date
- 16/11/2015
- Last edited
- 10/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Scientific
2 Elenis Zografou str
Thessaloniki
GR- 54634
Greece
 ORCID ID |
0000-0002-5151-9449 |
|---|---|
| Phone | +30 2313 322 178 |
| tasoskatsourakis@hotmail.com |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 patients |
| Total final enrolment | 43 |
| Participant inclusion criteria | Adult patients with pancreatic neoplasms that are fit for surgery |
| 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
Thessaloniki
GR-54634
Greece
Sponsor information
Hospital/treatment centre
2 Elenis Zografou str
Thessaloniki
GR-54634
Greece
| Phone | +30 2313 322 100/178 |
|---|---|
| tasoskatsourakis@hotmail.com | |
"ROR" |
https://ror.org/02j61yw88 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/11/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 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. |
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 |
Editorial Notes
10/06/2019: Publication reference and total final enrolment added.
11/01/2019: Publication reference added.
14/09/2017: IPD sharing statement added.
04/05/2016: Recruitment and overall study end dates changed from 30/04/2016 to 30/06/2016.
