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Completed

NCT Number: NCT04589338

Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease

This is a prospective interventional study. The investigators will include patients in clinical remission who are on stable treatment. These IBD patients will be followed to analyze the effects of physical activity on their inflammatory disease. Different exercises will be offered to two separate groups of randomly distributed patients: the first group will perform muscle building exercises while the other group will be offered aerobic exercises.There will also be a control group that does not initially benefit from a specific physical activity program. However, this group will be integrated into one of the other two groups after the 10-week follow-up. All three groups will perform the same baseline tests. These will be of different types: physical tests, biological tests and quality of life questionnaires.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Exercise Therapy Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Liège

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients in remission defined by a Harvey Bradshaw Index 5 in Crohn's disease (CD) and a clinical Mayo 3 with no sub-score >1 in ulcerative colitis (RCUH) with stable treatment, without corticosteroid for 4 months.
  • Patients accepting the study protocol

Exclusion criteria

  • Patients suffering from other pathologies (at the level of the digestive system, the cardiovascular system, as well as the musculoskeletal system: recent knee plasty, recent knee fractures, etc.), which can interfere with planned tests and activity programs.
  • Patients with more than 3 hours of sports activity per week
  • Pregnant, pregnant or nursing patients

Treatment and study plan

Endurance training

Other

This group will perform aerobic type exercises. Initially, patients will perform continuous exercises of progressive intensity in order to adapt to this kind of effort. Next, we will introduce interval exercises.

Resistance training

Other

Patients in this group will perform lower limb strengthening exercises to improve the maximum strength of different muscle groups.

Primary outcomes

  1. Progressive effort test on bicycle ergometer (VO2 max)

    Time frame: day 1

    This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)

  2. Progressive effort test on bicycle ergometer (VO2 max)

    Time frame: through study completion, an average of 40 weeks

    This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)

  3. Progressive effort test on bicycle ergometer (Heart rate)

    Time frame: day 1

    This test allows to measure resting and maximum heart rate (thanks to an ECG) and maximum aerobic power in Watt.

  4. Progressive effort test on bicycle ergometer (Heart rate)

    Time frame: through study completion, an average of 40 weeks

    This test allows to measure resting and maximum heart rate (thanks to an ECG) and maximum aerobic power in Watt.

  5. Progressive effort test on bicycle ergometer (Power)

    Time frame: day 1

    This test allows to measure maximum aerobic power in Watt.

  6. Progressive effort test on bicycle ergometer (Power)

    Time frame: through study completion, an average of 40 weeks

    This test allows to measure maximum aerobic power in Watt.

  7. Maximum force test (N/m)

    Time frame: Day 1

    This test will be performed using an isokinetic dynamometer. This evaluation will allow us to determine the maximum force of the quadriceps and hamstrings of each participant in N/m.

  8. Maximum force test (N/m)

    Time frame: through study completion, an average of 40 weeks

    This test will be performed using an isokinetic dynamometer. This evaluation will allow us to determine the maximum force of the quadriceps and hamstrings of each participant in N/m.

  9. Blood sample

    Time frame: Day 1

    This type of tests includes biological monitoring to obtain information on biological parameters.

  10. Blood sample

    Time frame: through study completion, an average of 40 weeks

    This type of tests includes biological monitoring to obtain information on biological parameters.

  11. Saddle analysis

    Time frame: Day 1

    This type of tests includes biological monitoring to obtain information on biological parameters.

  12. Saddle analysis

    Time frame: through study completion, an average of 40 weeks

    This type of tests includes biological monitoring to obtain information on biological parameters.

  13. IBD-F

    Time frame: Week 1

    Participants will complete a questionnaire on fatigue perceived.

  14. IBD-F

    Time frame: Week 10

    Participants will complete a questionnaire on fatigue perceived.

  15. IBD-F

    Time frame: Week 20

    Participants will complete a questionnaire on fatigue perceived.

  16. Godin Leisure Time exercise questionnaire

    Time frame: Week 1

    Participants will complete a questionnaire on the level of physical activity

  17. Metabolic Equivalent Task questionnaire

    Time frame: Week 1

    Participants will complete a questionnaire on the level of inactivity

  18. Metabolic Equivalent Task questionnaire

    Time frame: Week 10

    Participants will complete a questionnaire on the level of inactivity

  19. Metabolic Equivalent Task questionnaire

    Time frame: Week 20

    Participants will complete a questionnaire on the level of inactivity

  20. Short Food Frequency Questionnaire

    Time frame: Week 1

    Participants will complete a questionnaire on their dietary habits

  21. Short Food Frequency Questionnaire

    Time frame: Week 10

    Participants will complete a questionnaire on their dietary habits

  22. Short Food Frequency Questionnaire

    Time frame: Week 20

    Participants will complete a questionnaire on their dietary habits

  23. EQ5D questionnaire

    Time frame: Week 1

    Participants will complete a questionnaire on their level of health

  24. EQ5D questionnaire

    Time frame: Week 10

    Participants will complete a questionnaire on their level of health

  25. EQ5D questionnaire

    Time frame: Week 20

    Participants will complete a questionnaire on their level of health

  26. Short health scale questionnaire

    Time frame: Week 1

    Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease

  27. Short health scale questionnaire

    Time frame: Week 10

    Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease

  28. Short health scale questionnaire

    Time frame: Week 20

    Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Acronym: ACHILLE

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 19, 2020
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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