Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment
Popcorn
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Mar 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 8, 2022
February 1, 2022
1.8 years
February 16, 2022
February 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
6 minute walk test (6mwt)
6 minute walk test (6mwt)
12 weeks
Secondary Outcomes (22)
30 s chair stand test
12 weeks
Test of hand grip strength
12 weeks
International Physical Activity Questionnaire
12 weeks
Cardiopulmonary exercise test with ventilatory gas analysis
12 weeks
The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria
12 weeks
- +17 more secondary outcomes
Study Arms (2)
Prehabilitation
EXPERIMENTALPrehabilitation with physical exercise, psychological support, nutritional support and smoking/alchohol stop
Standard care
ACTIVE COMPARATORStandard preoperative recomendations
Interventions
Eligibility Criteria
You may qualify if:
- Patients, aged 18 or older, who have been evaluated as eligible for surgery for malignancy in the esophagus, rectum or liver (only metastases from colorectal cancer) will be evaluated for participation.
You may not qualify if:
- Surgery is scheduled in less than 12 weeks.
- Paralytic or completely immobilized patient, condition making physical training impractical.
- Cognitive disability making participation impossible.
- Not speaking or understanding the Swedish language well enough to read and understand the informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bergthor Björnsson, MD, PhD
Linkoeping University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 16, 2022
First Posted
March 8, 2022
Study Start
March 1, 2022
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
March 8, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share