The aim of this study is to investigate feasibility of a prehabilitation program for colorectal cancer patients aged * 65 years before surgery.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Is it feasible to provide 80% of included colorectal cancer patients with
supervised exercise training and/or protein-rich meals before surgery? Yes or
no?
Secondary outcome
Logistical feasibility
a. Success rate meal order and delivery
b. Success rate supervised exercise training and attendance
Feasibility of the interventions
c. Total protein-intake in grams and in grams/kilogram bodyweight
d. Total energy-intake in kilocalories and as percentage of the calculated
energy need (Harris Benedict)
e. Achievement of at least 80% of the calculated protein- and energy
requirement within the first week of the study
f. Amount of additional prescribed supplement drink according to usual care
based on the individually calculated needs
g. Distribution of protein and energy intake in one day
h. Compliance to exercise program of 80%
i. Success rate training program endurance
j. Average endured time of training program
k. Average achieved training intensity
l. Patient evaluation questionnaire: overall experience
Other study parameters (measurable outcomes)
m. Anthropomorphic and demographic parameters
n. Disease related demographics
o. Laboratory values: Hb, CRP, L, CEA, albumin, glucose, ferritin, vitamin D,
liver- and kidney function test.
p Comorbidities
q. Postoperative complications
r. Nutritional assessments (length, height, BMI, current weight)
s. Short Nutritional Assessment Questionnaire (SNAQ)
t. Groningen Frailty Index (GFI)
u. Health related quality of life (outpatient, EORTC QLQC-30)
v. VAS score appetite
w. VAS score food experience
x. Handgrip strength test (according to the South Hampton protocol)
y. Bioelectrical impedance analysis (BIA)
z. Maximal oxygen uptake (VO2max)
Background summary
Globally, the life expectancy has increased to 60 years of age and above. With
increasing age of the population, more elderly patients are being admitted in
the hospital for either chronic or acute treatment. The older patient requires
a different approach when being treated. The functional and nutritional status
of a patient has been proven to be important prognostic factors for recovery
after surgery. Elderly patients are commonly frail, sarcopenic and
undernourished. Standard dietary interventions seem to suffice, however do not
tackle all contributing factors. We believe that by intervening with a
prehabilitation program composed of supervised exercise training and
protein-rich meals, we could improve the functional capacity of a patient.
Study objective
The aim of this study is to investigate feasibility of a prehabilitation
program for colorectal cancer patients aged * 65 years before surgery.
Study design
the study design is a prospective feasibility study.
Intervention
this multimodal prehabilitation intervention is composed of a supervised
exercise training program and provision of freshly prepared protein-rich meals
supplied by Daily Fresh Food. The intervention takes place in the preoperative
period between diagnosis and surgery for colorectal cancer.
Study burden and risks
A benefit of participating in this study is, that it may provide an innovative
way to improve physical functioning before colorectal cancer surgery.
Furthermore, we expect an improved quality of life and satisfaction due to the
exercise training program and freshly prepared meals. It is hypothesized, that
this will build resistance against the trauma of surgery and reduce geriatric
frailty. Very few risks are associated with the participation of this study, as
patients who participate with the exercise training are continuously supervised
by experienced professionals. We expect no adverse events due to this study.
Though chances are very small, a food allergy may arise or a sprain during
training.
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
- Signed informed consent
- Scheduled to undergo elective colorectal surgery with primary anastomosis for
(pre)malignancy;
- 65 years or older;
- BMI < 35kg/m2;
- Physically and mentally capable of completing the exercise program;
- Capability to have a complete oral dietary intake.
Exclusion criteria
- Participant is receiving parenteral nutrition or enteral nutrition via
feeding tube in the preoperative phase;
- BMI >35 kg/m²;
- A history of or an active inflammatory gastrointestinal disease;
- Patients with a palliative treatment course;
- Inability or contraindication to performing physical exercise;
- Complex dietary needs and/or dietary allergies;
- Mentally incompetent or challenged.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70834.096.19 |