The aim of this randomized controlled pilot study is to investigate the feasibility and to improve the functional recovery of a patient, by providing them with a multimodal prehabilitation program consisting of supervised physical exercise and/or…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is functional capacity. This is measured with the validated
6-minute walking test (6MWT).
Secondary outcome
a. Postoperative complications within 30 days (Clavien Dindo)
b. Time to functional recovery
c. Health related quality of life (outpatient, EORTC QLQC-30)
d. VAS score appetite (see appendix 4)
e. VAS score food experience (see appendix 5)
f. Handgrip strength test (according to the South Hampton protocol)
g. Bioelectrical impedance analysis (BIA)
h. Time Up and Go Test (TUGT)
i. Maximal oxygen uptake (VO2max)
j. Short Physical Performance Battery (SPPB)
k. Sarcopenia (measured with preoperative abdominal CT-scan)
Other outcomes
a. Anthropomorphic and demographic parameters
b. Disease related demographics
c. Laboratory values: Hb, CRP, leukocytes, CEA, albumin, glucose, ferritin,
vitamin D, liver- and kidney function test.
d. Comorbidities
e. Nutritional assessments (length, height, BMI, current weight)
f. Short Nutritional Assessment Questionnaire (SNAQ)
g. Groningen Frailty Index (GFI)
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/or
protein-rich meals, we could improve the functional recovery of a patient.
Study objective
The aim of this randomized controlled pilot study is to investigate the
feasibility and to improve the functional recovery of a patient, by providing
them with a multimodal prehabilitation program consisting of supervised
physical exercise and/or protein-rich meals before surgery.
Study design
This is prospective randomized controlled pilot study
Intervention
This multimodal prehabilitation intervention is composed of a supervised
exercise training program and/or provision of freshly prepared protein-rich
meals supplied by Daily Fresh Food. The intervention takes place in the period
leading up to colorectal cancer surgery.
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 &
questionnaires;
- 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;
- Participants who are scheduled to receive neoadjuvant therapy;
- BMI >35 kg/m²;
- A history of or an active inflammatory gastrointestinal disease;
- Distant metastasis at the time of diagnosis (TNM stage M1);
- Inability or contraindication to performing physical exercise;
- Complex dietary needs and/or dietary allergies;
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 | NL70836.096.19 |