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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Exercise Therapy
• Intervention / Treatment: Other: Endurance training; Other: Resistance training

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Université de Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): February 7, 2023

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 20202021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No