Physical training and nutrition before abdominal surgery for Crohn's disease

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Auteurs
Catégorie Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: Randomisation 1:1 to prehabilitation or control treatment is based on a sequence of random numbers. The sequence will be stratified for study site (Stockholm and Montréal) and gender. The sequence will be concealed by opaque envelopes. Prehabilitation entails endurance and resistance exercise and tailored protein supplementation. Participants will perform exercise five times per week for 4 weeks (20 occasions). Exercise is performed in the hospital once a week and at home four times per week. On each training occasion, endurance exercise is performed for 32 minutes on a stationary exercise bicycle (in hospital) or by jogging or brisk walking (at home) to a Borg score of 13‐15. Resistance exercise is performed three times per week, and not on consecutive days. Two sets of 10 repetitions of elastic band loading and own bodyweight of six major muscle groups are performed: leg press, chest press, abdominal crunches floor, lateral pull‐down, low row and step up. A target dietary protein intake of 1.5‐1.8 g/kg bodyweight in all patients will be achieved by dietary advice and/or adding oral nutritional supplements to the baseline diet. In addition, participants in the prehabilitation group will receive whey protein within 30 min following each exercise (5 days a week) and before sleep (7 days a week) at the following doses: 20 g (bodyweight less or equal to 50 kg), 30 g (bodyweight 51‐80 kg) or 40 g (bodyweight 81 kg or more). Participants randomised to the control group will receive current standard care during their preoperative period. They will not receive protein supplements. CONDITION: Crohn's disease requiring abdominal surgery ; Digestive System ; Crohn disease [regional enteritis] PRIMARY OUTCOME: Physical performance measured using the 6‐minute walk test at baseline, after prehabilitation/control and 4 and 8 weeks after surgery SECONDARY OUTCOME: ; 1. Physical performance measured using the timed stands test‐30 at baseline, after prehabilitation/control and 4 and 8 weeks after surgery; 2. Physical performance measured using handgrip strength at baseline, after prehabilitation/control and 4 and 8 weeks after surgery; 3. Physical performance measured using the arm curl test‐30 at baseline, after prehabilitation/control and 4 and 8 weeks after surgery; 4. Dominant leg thigh muscle area using magnetic resonance imaging at baseline, after prehabilitation/control and 4 and 8 weeks after surgery; 5. Patient‐reported outcomes at baseline, after prehabilitation/control and 4 and 8 weeks after surgery:; 5.1. General quality of life assessed using EuroQoL 5D‐5L; 5.2. Symptoms from Crohn's disease assessed using Harvey Bradshaw Index; 5.3. Ability to do important daily activities assessed using Instrumental Activities of Daily Living (IADL); 6. Compliance with intervention measured by self‐reported proportion of endurance and resistance exercises during the 20 daily exercises over the 4‐week period before surgery; 7. Total physical activity measured by a high‐resolution activity tracker over the 4‐week period before surgery; 8. Postoperative length of stay measured using observation of the hospital stay at the duration of the stay after surgery (usually 2‐10 days); 9. 30‐day postoperative morbidity measured using patient record review at 30 days after surgery; INCLUSION CRITERIA: 1. Adults (aged =16 years) 2. Listed for elective or expedited (within weeks) small or large intestinal resection by laparoscopy or laparotomy for Crohn’s disease 3. At Ersta Hospital, Stockholm, and McGill University Health Centre, Montréal
Epistemonikos ID: 23a9e5a47c24cb43e7274cad1427a37e8bcd680a
First added on: Aug 25, 2024