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

Prehabilitation in abdominal surgery for Crohn's disease: a randomised trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10756924

Enrollment

Registered

2021-11-16

Start date

2021-01-01

Completion date

Unknown

Last updated

2024-09-23

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

Conditions

Crohn's disease requiring abdominal surgery Digestive System Crohn disease [regional enteritis]

Interventions

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 wil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 10/09/2024: 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 Previous participant 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

Exclusion criteria

Exclusion criteria: 1. Inability to participate in the prehabilitation programme components 2. Operation performed through a peristomal incision alone

Design outcomes

Primary

Measure	Time frame
Physical performance measured using the 6-minute walk test at baseline, after prehabilitation/control and 4 and 8 weeks after surgery	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Sweden

Contacts

Public ContactCharlotte Jonsson

forskningsenheten@erstadiakoni.se+46 (0)8 714 6500

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026