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*Better Exercise and FOod, better REcovery: *Improving physical functioning and quality of life by preoperative training and nutritional supplementation in older patients undergoing colorectal cancer surgery. A pilot study.'

*Better Exercise and FOod, better REcovery: *Improving physical functioning and quality of life by preoperative training and nutritional supplementation in older patients undergoing colorectal cancer surgery. A pilot study.' - BEFORE - pilot study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48140
Enrollment
40
Registered
2019-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

reduced muscle mass under nutrition

Interventions

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 intervent

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Signed informed consent; - Scheduled to undergo elective colorectal surgery with primary anastomosis for (pre)malignancy; - 65 years or older; - BMI

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
The primary outcome is functional capacity. This is measured with the validated 6-minute walking test (6MWT).—

Secondary

MeasureTime frame
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)—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)