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

Inflammatory Bowel Diseases Clinical Trial

— ACHILLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04589338
• Other study ID #: 20202021
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: February 7, 2023

Study information

• Verified date: May 2023
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 7, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Therapy
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
Belgium	Université de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

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