Better Exercise and FOod, better REcovery: Is it feasible to enhance functional and nutritional status of elderly colorectal cancer patients before surgery to improve recovery?

Better Exercise and FOod, better REcovery: Is it feasible to enhance functional and nutritional status of elderly colorectal cancer patients before surgery to improve recovery? - BEFORE - feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48054

Enrollment

Registered

2019-08-19

Start date

2019-11-19

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 provision of freshly prepared protein-rich meals supplied by Daily Fresh Food. The intervention

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; - 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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)