Clinical trial NCT04589338: Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease
Official title: Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Exercise Therapy
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progressive effort test on bicycle ergometer (VO2 max)
timeFrame: day 1
measure: Progressive effort test on bicycle ergometer (VO2 max)
timeFrame: through study completion, an average of 40 weeks
measure: Progressive effort test on bicycle ergometer (Heart rate)
timeFrame: day 1
measure: Progressive effort test on bicycle ergometer (Heart rate)
timeFrame: through study completion, an average of 40 weeks
measure: Progressive effort test on bicycle ergometer (Power)
timeFrame: day 1
measure: Progressive effort test on bicycle ergometer (Power)
timeFrame: through study completion, an average of 40 weeks
measure: Maximum force test (N/m)
timeFrame: Day 1
measure: Maximum force test (N/m)
timeFrame: through study completion, an average of 40 weeks
measure: Blood sample
timeFrame: Day 1
measure: Blood sample
timeFrame: through study completion, an average of 40 weeks
measure: Saddle analysis
timeFrame: Day 1
measure: Saddle analysis
timeFrame: through study completion, an average of 40 weeks
measure: IBD-F
timeFrame: Week 1
measure: IBD-F
timeFrame: Week 10
measure: IBD-F
timeFrame: Week 20
measure: Godin Leisure Time exercise questionnaire
timeFrame: Week 1
measure: Metabolic Equivalent Task questionnaire
timeFrame: Week 1
measure: Metabolic Equivalent Task questionnaire
timeFrame: Week 10
measure: Metabolic Equivalent Task questionnaire
timeFrame: Week 20
measure: Short Food Frequency Questionnaire
timeFrame: Week 1
measure: Short Food Frequency Questionnaire
timeFrame: Week 10
measure: Short Food Frequency Questionnaire
timeFrame: Week 20
measure: EQ5D questionnaire
timeFrame: Week 1
measure: EQ5D questionnaire
timeFrame: Week 10
measure: EQ5D questionnaire
timeFrame: Week 20
measure: Short health scale questionnaire
timeFrame: Week 1
measure: Short health scale questionnaire
timeFrame: Week 10
measure: Short health scale questionnaire
timeFrame: Week 20
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Université de Liège
Study officials:
References: