Investigate whether continuous monitoring of physical activity with an activity tracker leads to an improvement in preoperative endurance in elderly people with colorectal cancer, compared to a standard preoperative route with prehabilitation.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is an improvement of >=50 meters on the 6 minute walk test on
the day before surgery, compared to the start of the prehabilitation program.
Secondary outcome
Secondary endpoints are preoperative muscle strength (hand grip strength and
Five Times Sit to Stand (FTSTS) test) and quality of life, serious
postoperative complications (Clavien Dindo grade >=3) within 30 days, quality of
life and functional limitations at 3 months.
Background summary
Preoperative physical inactivity is a major cause of loss of function after
abdominal surgery. The preoperative period can be used to improve the muscle
strength and endurance of patients (prehabilitation). Compliance plays an
important role in successful prehabilitation. This study investigates the
effect of an activity tracker on preoperative endurance in elderly people with
colorectal cancer.
Study objective
Investigate whether continuous monitoring of physical activity with an activity
tracker leads to an improvement in preoperative endurance in elderly people
with colorectal cancer, compared to a standard preoperative route with
prehabilitation.
Study design
Randomized controlled singel center trial
Study burden and risks
Control group: Completing two additional questionnaires (EORTC QLQ-C30 and
WHODAS-2.0 12-item, appendix 1 and 2) at the start of the study, upon admission
before surgery and after 3 months, performing a 6-minute walking test, grip
strength and FTSTS (total ± 20 minutes) at study start and before surgery,
standard prehabilitation program (Appendix 3). Intervention group: Completing
the additional questionnaires at the start of the study, at admission to
hospital and after 3 months, performing a 6 minute walk test, squeeze force and
FTSTS (in total ± 20 minutes) at the start of the study and before the
operation, wearing an activity tracker (Fitbit) during the day, digital sharing
of anonymous activity tracking data
Koekoekslaan 1 Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1 Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
Inclusion criteria
Elective surgery for colorectal cancer
Age 70 or above
Exclusion criteria
Double tumor
Metastatic disease
Neoadjuvant chemo/radiotherapy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77624.100.21 |