Physical Activity Clinical Trial
— PACOSOfficial title:
Physical Activity and Its Impact on Colon Cancer Surgery: Clinical and Histological Effects
NCT number | NCT03947840 |
Other study ID # | PACOS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 30, 2019 |
Est. completion date | February 20, 2024 |
Verified date | February 2024 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is a prospective clinical study that studies how the physical activity level before operation of colon cancer affects the outcome of complication and histology. The hypothesis is that patients who are more physical active have less postoperative complications and different histological immunological response around the tumor. The investigators are testing the patients before the surgery with physical tests for fitness, strength and physical activity level. Questionnaires are also filled by the patients for pain, anxiety, depression and motivation for life style changes. Their body mass is analyzed with a DEXA (Dual-energy X-ray absorptiometry scan). For one years the investigators are monitoring their activity and follow up for physical tests, DEXA and questionnaires is at 6 and 12 months. The histology is analyzed after surgery to se if there is a different immunological response around the tumor.
Status | Completed |
Enrollment | 85 |
Est. completion date | February 20, 2024 |
Est. primary completion date | February 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years. - Colon cancer which is going to surgery Exclusion Criteria: - Not able to do physical tests - Severe disease that makes a risk to do tests. - Not able to make informed consent due to psychic disease or dementia |
Country | Name | City | State |
---|---|---|---|
Sweden | Region Vasterbotten, centre of surgery | Umeå | Vasterbotten |
Lead Sponsor | Collaborator |
---|---|
Umeå University | Västerbotten County Council, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of postoperative complications | To study if there are differences in postoperative complications in different active patients. | 1 year | |
Primary | Rate of immunological response | To study if there is a difference in immunological reaction among physical active patients. | 1 year | |
Secondary | Rate of recovery in physical activity | To study if physical active patients have a faster postoperative recovery | 1 year |
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