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

Study Overview
=================
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.

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

Conditions
-----------------
Inflammatory Bowel Diseases, Exercise Therapy

Intervention / Treatment
-----------------
* Other: Endurance training
* Other: Resistance training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endurance training group<br> | Other: Endurance training<br>* 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.<br>|
| Experimental: Resistance training group<br> | Other: Resistance training<br>* Patients in this group will perform lower limb strengthening exercises to improve the maximum strength of different muscle groups.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive effort test on bicycle ergometer (VO2 max) | This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases) | day 1 | 
| Progressive effort test on bicycle ergometer (VO2 max) | This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases) | through study completion, an average of 40 weeks | 
| Progressive effort test on bicycle ergometer (Heart rate) | This test allows to measure resting and maximum heart rate (thanks to an ECG) and maximum aerobic power in Watt. | day 1 | 
| Progressive effort test on bicycle ergometer (Heart rate) | This test allows to measure resting and maximum heart rate (thanks to an ECG) and maximum aerobic power in Watt. | through study completion, an average of 40 weeks | 
| Progressive effort test on bicycle ergometer (Power) | This test allows to measure maximum aerobic power in Watt. | day 1 | 
| Progressive effort test on bicycle ergometer (Power) | This test allows to measure maximum aerobic power in Watt. | through study completion, an average of 40 weeks | 
| Maximum force test (N/m) | 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. | Day 1 | 
| Maximum force test (N/m) | 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. | through study completion, an average of 40 weeks | 
| Blood sample | This type of tests includes biological monitoring to obtain information on biological parameters. | Day 1 | 
| Blood sample | This type of tests includes biological monitoring to obtain information on biological parameters. | through study completion, an average of 40 weeks | 
| Saddle analysis | This type of tests includes biological monitoring to obtain information on biological parameters. | Day 1 | 
| Saddle analysis | This type of tests includes biological monitoring to obtain information on biological parameters. | through study completion, an average of 40 weeks | 
| IBD-F | Participants will complete a questionnaire on fatigue perceived. | Week 1 | 
| IBD-F | Participants will complete a questionnaire on fatigue perceived. | Week 10 | 
| IBD-F | Participants will complete a questionnaire on fatigue perceived. | Week 20 | 
| Godin Leisure Time exercise questionnaire | Participants will complete a questionnaire on the level of physical activity | Week 1 | 
| Metabolic Equivalent Task questionnaire | Participants will complete a questionnaire on the level of inactivity | Week 1 | 
| Metabolic Equivalent Task questionnaire | Participants will complete a questionnaire on the level of inactivity | Week 10 | 
| Metabolic Equivalent Task questionnaire | Participants will complete a questionnaire on the level of inactivity | Week 20 | 
| Short Food Frequency Questionnaire | Participants will complete a questionnaire on their dietary habits | Week 1 | 
| Short Food Frequency Questionnaire | Participants will complete a questionnaire on their dietary habits | Week 10 | 
| Short Food Frequency Questionnaire | Participants will complete a questionnaire on their dietary habits | Week 20 | 
| EQ5D questionnaire | Participants will complete a questionnaire on their level of health | Week 1 | 
| EQ5D questionnaire | Participants will complete a questionnaire on their level of health | Week 10 | 
| EQ5D questionnaire | Participants will complete a questionnaire on their level of health | Week 20 | 
| Short health scale questionnaire | Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease | Week 1 | 
| Short health scale questionnaire | Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease | Week 10 | 
| Short health scale questionnaire | Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease | Week 20 |